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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized, Parallel-Group, Active- and Placebo-Controlled Polysomnography Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42847922 in Subjects With Insomnia Disorder

    Summary
    EudraCT number
    2017-000980-33
    Trial protocol
    DE   BE   PL   FR  
    Global end of trial date
    03 Apr 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Apr 2020
    First version publication date
    16 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    42847922ISM2005
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03375203
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, B-2340
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Apr 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the dose-response of 3 doses of seltorexant (5 milligram [mg], 10 mg, and 20 mg) compared to placebo on an objective measure of sleep onset in subjects with insomnia disorder.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. Safety evaluations were based on adverse events, clinical laboratory tests (hematology, serum chemistry, and urinalysis), vital sign measurements, physical examinations, electrocardiogram (ECG), Cognitive assessment (modified Patient Reported Outcome Measurement Information System-Applied Cognition Abilities [PROMIS-ACA] and cognitive functioning evaluations), residual effects (Karolinska Sleepiness Scale [KSS], body sway), withdrawal effects (Physician Withdrawal Checklist [PWC], Benzodiazepine Withdrawal Symptom Questionnaire [BWSQ]), Columbia Suicide Severity Rating Scale (C-SSRS).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Nov 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Germany: 43
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Japan: 21
    Country: Number of subjects enrolled
    Poland: 5
    Country: Number of subjects enrolled
    United States: 285
    Worldwide total number of subjects
    364
    EEA total number of subjects
    58
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    238
    From 65 to 84 years
    126
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Total of 365 subjects were randomized, 364 were treated. 1 subject was randomized in error group never received study drug, was discontinued from study. 1 subject was randomized to JNJ-42847922 10 mg group received 5 mg of JNJ-42847922 and was summarized under 5 mg group for safety analyses, and under 10 mg dose group for all other analyses.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Arm title
    JNJ-42847922 5 mg
    Arm description
    Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-42847922
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Arm title
    JNJ-42847922 10 mg
    Arm description
    Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-42847922
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo oral capsule for 14 consecutive nights from Day 1 to Day 14.

    Arm title
    JNJ-42847922 20 mg
    Arm description
    Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-42847922
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo oral capsule for 14 consecutive nights from Day 1 to Day 14.

    Arm title
    Zolpidem
    Arm description
    Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.
    Arm type
    Active comparator

    Investigational medicinal product name
    Zolpidem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Zolpidem 5 mg as one 5 mg capsule and one placebo oral capsule, or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Number of subjects in period 1
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Started
    75
    71
    74
    71
    73
    Completed
    69
    68
    72
    69
    69
    Not completed
    6
    3
    2
    2
    4
         Protocol deviation
    -
    -
    1
    -
    -
         Adverse event, serious non-fatal
    -
    -
    -
    1
    -
         Non-compliance with study drug
    1
    -
    -
    -
    -
         Withdrawal by subject
    3
    -
    1
    -
    2
         Adverse event, non-fatal
    2
    3
    -
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 5 mg
    Reporting group description
    Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 10 mg
    Reporting group description
    Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 20 mg
    Reporting group description
    Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    Zolpidem
    Reporting group description
    Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Reporting group values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem Total
    Number of subjects
    75 71 74 71 73 364
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0
        Adults (18-64 years)
    50 45 48 47 48 238
        From 65 to 84 years
    25 26 26 24 25 126
        85 years and over
    0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    58.6 ± 11.49 56.9 ± 13.85 57.6 ± 12.9 57.6 ± 11.88 58.5 ± 12.03 -
    Title for Gender
    Units: subjects
        Female
    45 48 51 50 52 246
        Male
    30 23 23 21 21 118

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 5 mg
    Reporting group description
    Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 10 mg
    Reporting group description
    Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 20 mg
    Reporting group description
    Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    Zolpidem
    Reporting group description
    Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Subject analysis set title
    JNJ-42847922 5 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject is summarized under the 5 mg dose group for safety analyses.

    Subject analysis set title
    JNJ-42847922 10 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject is summarized under the 5 mg dose group for safety analyses.

    Subject analysis set title
    JNJ-42847922 20 mg
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.

    Subject analysis set title
    Zolpidem
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Primary: Change from Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1

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    End point title
    Change from Baseline in Latency to Persistent Sleep (LPS) as Measured by Polysomnography (PSG) on Night 1
    End point description
    LPS was measured on Night 1 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep. The LPS change from baseline on Night 1 was calculated as (LPS at Night 1 minus Baseline LPS). Negative changes in LPS indicated improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Primary
    End point timeframe
    Baseline and Night 1
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    73
    71
    73
    Units: Minutes
        arithmetic mean (standard deviation)
    -15.24 ± 78.547
    -29.92 ± 49.049
    -49.49 ± 53.216
    -47.69 ± 48.423
    -40.74 ± 54.395
    Statistical analysis title
    Stastistical Analysis 1
    Comparison groups
    JNJ-42847922 5 mg v Placebo
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.346
    Method
    ANCOVA
    Parameter type
    Back-transformed Least Square Mean Ratio
    Point estimate
    0.88
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    1.1
    Statistical analysis title
    Stastistical Analysis 2
    Comparison groups
    Placebo v JNJ-42847922 10 mg
    Number of subjects included in analysis
    148
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.001
    Method
    ANCOVA
    Parameter type
    Back-transformed Least Square Mean Ratio
    Point estimate
    0.64
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.51
         upper limit
    0.81
    Statistical analysis title
    Stastistical Analysis 3
    Comparison groups
    Placebo v JNJ-42847922 20 mg
    Number of subjects included in analysis
    146
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    Back-transformed Least Square Mean Ratio
    Point estimate
    0.51
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.41
         upper limit
    0.64

    Secondary: Change from Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1

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    End point title
    Change from Baseline in Wake After Sleep Onset (WASO) Over the First 6 Hours as Measured by PSG on Night 1
    End point description
    Polysomnography was used to measure the time to wake after initial sleep onset over the first 6 hours (WASO-6) on Night 1 was reported. Negative changes in WASO-6 indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Night 1
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    71
    73
    71
    73
    Units: Minutes
        arithmetic mean (standard deviation)
    -15.05 ± 57.485
    -22.70 ± 45.904
    -42.57 ± 40.011
    -44.69 ± 42.823
    -29.04 ± 46.779
    No statistical analyses for this end point

    Secondary: Change from Baseline in Latency to Persistent Sleep as Measured by PSG on Night 13

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    End point title
    Change from Baseline in Latency to Persistent Sleep as Measured by PSG on Night 13
    End point description
    LPS was measured on Night 13 by PSG. LPS is the time in minutes from 'lights out' that marks the starting of total recording time to the first epoch scored as sleep. Negative changes in LPS indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Night 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    69
    69
    73
    69
    69
    Units: Minutes
        arithmetic mean (standard deviation)
    -23.74 ± 61.790
    -27.12 ± 54.726
    -53.99 ± 60.292
    -41.19 ± 59.713
    -30.94 ± 60.236
    No statistical analyses for this end point

    Secondary: Change from Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13

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    End point title
    Change from Baseline in WASO Over the First 6 Hours as Measured by PSG on Night 13
    End point description
    Polysomnography was used to measure the time to wake after initial sleep onset over the first 6 hours (WASO-6) on Night 13 was reported. Negative changes in WASO-6 indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Night 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    68
    69
    73
    68
    69
    Units: Minutes
        arithmetic mean (standard deviation)
    -17.80 ± 52.369
    -14.63 ± 57.207
    -30.74 ± 52.835
    -38.40 ± 53.661
    -20.22 ± 46.465
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13

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    End point title
    Change from Baseline in Total Sleep Time (TST) as Measured by PSG Over 6 Hours on Nights 1 and 13
    End point description
    TST is defined as the total sleep time in minutes, the total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Nights 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    73
    71
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        Night 1 (n= 75, 71, 73, 71, 73)
    25.50 ± 72.146
    43.26 ± 50.771
    76.47 ± 50.711
    80.49 ± 56.216
    53.70 ± 57.688
        Night 13 (n=69, 69, 73, 69, 69)
    33.16 ± 71.488
    39.80 ± 66.556
    66.03 ± 62.995
    67.66 ± 66.254
    35.84 ± 64.950
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13

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    End point title
    Change from Baseline in Total Sleep Time (TST) as Measured by PSG Over 8 Hours on Nights 1 and 13
    End point description
    TST is defined as the total sleep time in minutes, the total sleep time is the total amount of sleep time scored during the total recording time. Positive changes in TST indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Nights 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    73
    71
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        Night 1 (n=75, 71, 73, 71, 73)
    37.03 ± 86.539
    47.85 ± 64.499
    81.20 ± 60.607
    81.07 ± 71.581
    63.88 ± 59.115
        Night 13 (n=69, 69, 73, 69, 69)
    38.45 ± 83.177
    45.72 ± 72.640
    64.84 ± 77.358
    64.27 ± 82.377
    39.26 ± 77.773
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13

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    End point title
    Change from Baseline in Sleep Efficiency (SE) Measured by PSG on Nights 1 and 13
    End point description
    Sleep efficiency was measured as the total sleep time divided by the total time in bed (that is, the number of hours from the beginning of the Polysomnography recording to the end of the recording) (in percent). Positive changes in SE indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Nights 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    73
    71
    73
    Units: Percent of efficient sleep
    arithmetic mean (standard deviation)
        Night 1 (n=75, 71, 73,71, 73)
    7.74 ± 18.031
    10.18 ± 12.818
    16.92 ± 12.626
    16.86 ± 14.963
    13.29 ± 12.317
        Night 13 (n=69, 69, 73,69, 69)
    7.99 ± 17.322
    9.51 ± 15.154
    13.67 ± 16.037
    13.56 ± 17.199
    8.27 ± 16.323
    No statistical analyses for this end point

    Secondary: Change from Baseline in Wake After Sleep Onset Total Score Measured Hourly on Day 1 and 13 from Hour 1 to Hour 8

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    End point title
    Change from Baseline in Wake After Sleep Onset Total Score Measured Hourly on Day 1 and 13 from Hour 1 to Hour 8
    End point description
    Polysomnography was used to measure the time to wake after initial sleep onset measured hourly on Day 1 and 13 from Hour 1 to Hour 8 was reported. WASO is measured during overnight sleep laboratory (PSG) assessment and defined as the duration of wakefulness from the onset of persistent sleep (that is, 10 consecutive minutes of sleep) over 8 hours of PSG assessment. Negative changes in WASO indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    71
    73
    71
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        WASO (hour 1): Day 1(n=43, 43, 47, 50, 48)
    -3.40 ± 13.074
    -3.55 ± 10.510
    -3.44 ± 12.969
    -6.37 ± 14.213
    -5.40 ± 12.086
        WASO (hour 1): Day 13(n=42, 41, 46, 48, 45)
    0.43 ± 12.083
    -4.78 ± 8.824
    -7.05 ± 14.569
    -7.47 ± 13.004
    -4.90 ± 11.821
        WASO (hour 2): Day 1(n=66, 62, 66, 67, 64)
    1.06 ± 18.481
    -5.72 ± 11.817
    -9.62 ± 16.721
    -10.82 ± 13.658
    -7.68 ± 14.812
        WASO (hour 2):Day 13(n=61, 63, 67, 63, 59)
    1.11 ± 18.504
    -4.12 ± 14.596
    -9.04 ± 17.034
    -9.64 ± 14.963
    -4.37 ± 16.883
        WASO (hour 3): Day 1(n=69, 69, 72, 70, 71)
    -5.57 ± 18.316
    -3.91 ± 12.037
    -11.05 ± 13.272
    -9.64 ± 13.055
    -9.62 ± 14.141
        WASO (hour 3): Day 13(n=64, 67, 71, 67, 66)
    -5.70 ± 17.681
    -0.31 ± 18.562
    -8.10 ± 12.446
    -6.99 ± 15.331
    -5.12 ± 18.140
        WASO (hour 4): Day 1(n=72, 71, 72, 71, 72)
    -5.33 ± 17.109
    -4.73 ± 13.193
    -9.67 ± 14.495
    -9.74 ± 14.727
    -6.23 ± 16.471
        WASO (hour 4): Day 13(n=67, 69, 71, 68, 67)
    -5.49 ± 18.185
    -3.47 ± 16.754
    -9.57 ± 14.483
    -6.21 ± 14.140
    -7.00 ± 15.727
        WASO (hour 5): Day 1(n= 73, 71, 73, 71, 73)
    -3.36 ± 22.284
    -6.16 ± 15.820
    -7.53 ± 14.371
    -7.44 ± 15.834
    -4.34 ± 16.150
        WASO (hour 5): Day 13(n=68, 69, 73, 69, 69)
    -4.96 ± 22.597
    -4.06 ± 20.776
    -5.34 ± 20.232
    -7.97 ± 17.016
    -5.03 ± 16.306
        WASO (hour 6): Day 1(n=74, 71, 73, 71, 73)
    -1.06 ± 17.258
    -4.46 ± 22.383
    -5.44 ± 17.510
    -7.78 ± 18.348
    -1.46 ± 19.965
        WASO (hour 6): Day 13(n=68, 69, 73, 69, 69)
    -4.69 ± 19.658
    -3.09 ± 21.426
    0.56 ± 22.721
    -7.37 ± 20.872
    0.84 ± 20.768
        WASO (hour 7): Day 1(n= 74, 71, 73,71, 73)
    -5.01 ± 22.247
    -5.71 ± 19.784
    -3.84 ± 16.756
    -1.61 ± 19.349
    -6.15 ± 13.756
        WASO (hour 7): Day 13(n=69, 69, 73,69, 69)
    -3.57 ± 21.828
    -4.92 ± 18.271
    -1.50 ± 21.145
    1.16 ± 23.642
    -0.75 ± 18.096
        WASO (hour 8): Day 1(n=74, 71, 73, 71, 73)
    -7.52 ± 23.369
    0.66 ± 21.311
    -0.65 ± 22.278
    1.25 ± 22.046
    -3.95 ± 20.149
        WASO (hour 8): Day 13(n=69, 69, 73, 69, 69)
    -1.73 ± 24.898
    -0.63 ± 20.118
    1.88 ± 23.845
    1.24 ± 20.858
    -3.22 ± 22.343
    No statistical analyses for this end point

    Secondary: Change from Baseline in Number of Nighttime Awakenings (nNAW) Over 6 Hours on Day 1 and 13

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    End point title
    Change from Baseline in Number of Nighttime Awakenings (nNAW) Over 6 Hours on Day 1 and 13
    End point description
    PSG was used to measure the number of nighttime awakening over the first 6 hours after initial sleep onset. Negative changes in nNAW indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    71
    73
    71
    73
    Units: Number of awakenings
    arithmetic mean (standard deviation)
        Day 1 (n=74, 71, 73, 71, 73)
    -2.08 ± 6.412
    -0.87 ± 7.224
    0.14 ± 7.385
    -0.94 ± 9.102
    -1.14 ± 8.727
        Day 13 (n=69, 69, 73, 69, 69)
    -2.02 ± 6.928
    0.93 ± 7.769
    -0.40 ± 8.352
    -2.13 ± 7.542
    -0.57 ± 7.803
    No statistical analyses for this end point

    Secondary: Change from Baseline in Wake During Total Sleep Period on Day 1 and 13

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    End point title
    Change from Baseline in Wake During Total Sleep Period on Day 1 and 13
    End point description
    PSG was used to measure wake time during the total recording period. Negative changes in wake during total sleep period indicate improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    71
    73
    71
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        Day 1(n=74, 71, 73, 71, 73)
    -13.79 ± 63.082
    -27.47 ± 58.188
    -49.64 ± 47.106
    -52.25 ± 40.828
    -32.36 ± 53.737
        Day 13(n= 69, 69, 73, 69,69)
    -18.83 ± 59.005
    -19.79 ± 60.626
    -42.57 ± 53.867
    -41.95 ± 64.846
    -20.58 ± 56.799
    No statistical analyses for this end point

    Secondary: Change from Baseline in Wake After Final Awakening on Day 1 and 13

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    End point title
    Change from Baseline in Wake After Final Awakening on Day 1 and 13
    End point description
    Polysomnography was used to measure the time awake after final awakening to the end of the PSG period. Negative changes in wake after final awakening indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    71
    73
    71
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        Day 1(n=74, 71, 73, 71, 73)
    -13.63 ± 50.958
    -0.28 ± 29.552
    2.80 ± 38.492
    7.21 ± 45.189
    -5.40 ± 29.473
        Day 13(n=69, 69, 73, 69, 69)
    -5.32 ± 55.112
    -0.39 ± 31.519
    12.42 ± 62.515
    5.62 ± 48.641
    -2.17 ± 29.376
    No statistical analyses for this end point

    Secondary: Change from Baseline in Number of Nighttime Awakenings per hour (nNAW/hr) on Day 1 and 13

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    End point title
    Change from Baseline in Number of Nighttime Awakenings per hour (nNAW/hr) on Day 1 and 13
    End point description
    PSG was used to measure number of nighttime awakenings per hour. Negative changes in nNAW/hr indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    71
    73
    71
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        Day 1(n=74, 71, 73, 71, 73)
    -0.35 ± 1.069
    -0.14 ± 1.204
    0.02 ± 1.231
    -0.16 ± 1.517
    -0.19 ± 1.455
        Day 13(n=69, 69, 73, 69, 69)
    -0.34 ± 1.155
    0.16 ± 1.295
    -0.07 ± 1.392
    -0.36 ± 1.257
    -0.10 ± 1.300
    No statistical analyses for this end point

    Secondary: Change from Baseline in Time to First Awakening After Sleep on Day 1 and 13

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    End point title
    Change from Baseline in Time to First Awakening After Sleep on Day 1 and 13
    End point description
    PSG was used to measure the time to first awakening after sleep onset. Positive changes in time to first awakening after sleep indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    71
    73
    70
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        Day 1(n=74, 71, 73, 70, 73)
    12.05 ± 57.535
    10.71 ± 61.015
    23.11 ± 73.749
    53.90 ± 92.802
    35.63 ± 74.617
        Day 13(n=69, 69, 71, 68, 67)
    11.08 ± 45.714
    32.13 ± 70.549
    33.12 ± 71.826
    48.92 ± 88.909
    27.55 ± 75.080
    No statistical analyses for this end point

    Secondary: Change from Baseline in Rapid Eye Movement (REM) duration on Day 1 and 13

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    End point title
    Change from Baseline in Rapid Eye Movement (REM) duration on Day 1 and 13
    End point description
    PSG was used to measure REM duration (time to first REM period from sleep onset). FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    71
    73
    71
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        Day 1(n=74, 71, 73, 71, 73)
    10.32 ± 24.366
    10.23 ± 28.891
    25.12 ± 29.495
    23.79 ± 31.175
    5.41 ± 22.381
        Day 13(n=69, 69, 73, 69, 69)
    5.70 ± 29.875
    6.40 ± 25.188
    17.42 ± 28.699
    12.91 ± 32.051
    5.97 ± 28.811
    No statistical analyses for this end point

    Secondary: Change from Baseline in Rapid Eye Movement Latency on Day 1 and 13

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    End point title
    Change from Baseline in Rapid Eye Movement Latency on Day 1 and 13
    End point description
    PSG was used to measure the REM latency. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    73
    70
    73
    70
    72
    Units: Minute
    arithmetic mean (standard deviation)
        Day 1 (n=73,70, 73, 70, 72)
    -26.60 ± 82.487
    -38.06 ± 79.396
    -85.61 ± 84.380
    -88.36 ± 76.551
    -42.73 ± 67.024
        Day 13 (n=67, 67, 72, 67, 67)
    -26.41 ± 87.903
    -32.11 ± 86.623
    -83.89 ± 83.313
    -73.40 ± 81.747
    -31.59 ± 64.953
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Sleep-Onset Rapid Eye Movement on Day 1 and 13

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    End point title
    Percentage of Subjects with Sleep-Onset Rapid Eye Movement on Day 1 and 13
    End point description
    PSG was used to measure the sleep-onset REM in subjects. REM sleep periods within 15 minutes from sleep onset were measured. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    73
    71
    73
    Units: Percentage of subjects
    number (not applicable)
        Day 1 (n=75, 71, 73, 71, 73)
    1.3
    4.2
    9.6
    14.1
    0
        Day 13 (n=69, 69, 73, 69, 69)
    1.4
    2.9
    4.1
    8.7
    2.9
    No statistical analyses for this end point

    Secondary: Change from Baseline in Number of Sleep Cycles on Day 1 and 13

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    End point title
    Change from Baseline in Number of Sleep Cycles on Day 1 and 13
    End point description
    PSG was used to measure the number of sleep cycles. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    73
    71
    73
    Units: Number of sleep cycles
    arithmetic mean (standard deviation)
        Day 1 (n=75, 71, 73, 71, 73)
    0.43 ± 1.138
    0.40 ± 1.006
    0.97 ± 1.049
    0.75 ± 1.155
    0.62 ± 0.941
        Day 13 (n=69, 69, 73, 69, 69)
    0.20 ± 1.222
    0.41 ± 1.062
    0.77 ± 1.182
    0.45 ± 1.219
    0.32 ± 0.955
    No statistical analyses for this end point

    Secondary: Change from Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep Stages N1, N2 and N3 on Day 1 and 13

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    End point title
    Change from Baseline in Total Time Spent in Non-Rapid Eye Movement Sleep Stages N1, N2 and N3 on Day 1 and 13
    End point description
    PSG was used to measure total time spent in non-rapid eye movement sleep stages N1, N2 and N3. Positive changes in NREM (total of N1-N3) duration indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 1 and 13
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    73
    71
    73
    Units: Minutes
    arithmetic mean (standard deviation)
        Day 1 (n= 75, 71, 73, 71, 73)
    27.87 ± 68.202
    37.62 ± 49.817
    56.08 ± 45.218
    57.29 ± 54.245
    58.47 ± 52.803
        Day 13 (n=69, 69, 73, 69, 69)
    32.74 ± 61.726
    39.33 ± 61.524
    47.41 ± 59.791
    51.37 ± 59.310
    33.28 ± 62.466
    No statistical analyses for this end point

    Secondary: Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)

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    End point title
    Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), Subjective Total Sleep Time (sTST)
    End point description
    CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to prior night's sleep. It allows for calculation of total time spent in bed and SE (as % of time asleep out of amount of time spent in bed). Sleep quality and how well rested subject felt at awaking are rated on a 5-point Likert scale ranges from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: sSOL, sTST, sWASO. Negative change in sSOL, sWASO indicate improvement. Positive change in sTST indicates improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint and 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 2 and 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    71
    66
    68
    69
    68
    Units: Minutes
    arithmetic mean (standard deviation)
        sSOL: Day 2 (n=71, 66, 68, 69, 68)
    15.20 ± 61.761
    -3.99 ± 46.858
    -16.49 ± 42.699
    -27.60 ± 34.456
    -24.98 ± 30.395
        sSOL: Day 14 (n=63, 64, 67, 65, 66)
    10.92 ± 68.201
    -8.81 ± 45.936
    -31.33 ± 36.888
    -33.93 ± 37.274
    -14.53 ± 53.705
        sWASO: Day 2 (n=69, 64, 68, 64, 61)
    0.81 ± 75.475
    -5.47 ± 61.067
    -18.54 ± 51.301
    -13.28 ± 48.225
    -15.99 ± 84.549
        sWASO : Day 14(n= 59, 61, 64, 62, 60)
    -5.60 ± 55.955
    -18.25 ± 56.719
    -25.20 ± 58.872
    -20.16 ± 65.568
    -17.56 ± 51.007
        sTST: Day 2 (n=71, 66, 68, 69, 68)
    -12.64 ± 96.051
    4.90 ± 92.105
    29.25 ± 67.934
    34.50 ± 76.904
    37.07 ± 71.297
        sTST: Day 14 (n=63, 64, 67, 65, 66)
    3.30 ± 89.019
    29.34 ± 83.772
    36.79 ± 88.379
    45.35 ± 81.983
    27.68 ± 90.387
    No statistical analyses for this end point

    Secondary: Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)

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    End point title
    Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
    End point description
    The CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE (as the percentage of time asleep out of amount of time spent in bed). Sleep quality and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement. Full analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 2 and 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    71
    66
    68
    69
    68
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        sFRESH: Day 2 (n=71, 66, 68, 69, 68)
    0.07 ± 0.930
    0.14 ± 0.865
    0.34 ± 0.852
    0.58 ± 1.050
    0.41 ± 0.876
        sFRESH: Day 14 (n=63, 64, 67, 65, 66)
    0.26 ± 0.826
    0.39 ± 1.081
    0.51 ± 1.005
    0.59 ± 1.018
    0.41 ± 1.051
        sQUAL: Day 2 (n=71, 66, 68, 69, 68)
    0.11 ± 0.995
    0.14 ± 1.054
    0.49 ± 0.896
    0.49 ± 1.091
    0.66 ± 0.818
        sQUAL: Day 14 (n=63, 64, 67, 65, 66)
    0.26 ± 1.024
    0.43 ± 1.172
    0.79 ± 1.189
    0.67 ± 1.159
    0.52 ± 1.084
    No statistical analyses for this end point

    Secondary: Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW)

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    End point title
    Change from Baseline in Subjective Sleep Parameters Using Consensus Sleep Diary - Morning Administration (CSD-M) on Days 2 and 14: Number of Nighttime Awakenings (s-nNAW)
    End point description
    CSD-M is a standardized participant diary based on expert consensus and qualitative participant input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE (as the percentage of time asleep out of amount of time spent in bed). Sleep quality and how well rested participants felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed include: s-nNAW. Negative change in s-nNAW indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 2 and 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    71
    66
    68
    69
    68
    Units: Number of awakenings
    arithmetic mean (standard deviation)
        Day 2 (n=71, 66, 68, 69, 68)
    0.64 ± 2.197
    0.21 ± 1.465
    0.49 ± 1.465
    0.27 ± 1.418
    0.38 ± 6.076
        Day 14 (n=63, 64, 67, 65, 66)
    0.10 ± 1.234
    0.04 ± 1.580
    0.05 ± 1.320
    -0.02 ± 1.175
    -0.22 ± 1.376
    No statistical analyses for this end point

    Secondary: Change from Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System – Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14

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    End point title
    Change from Baseline in Sleep Disturbance as Measured by Patient Reported Outcome Measurement Information System – Sleep Disturbance (PROMIS-SD) Total Score on Days 8 and 14
    End point description
    PROMIS Sleep Disturbance (PROMIS-SD) Short Form subscale consists of a static 8-item questionnaire. Using a recall period of the past 7 days, it assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Each question has 5 response options ranging in value from 1-5. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For the 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Lower scores indicate less sleep disturbance. Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 8 and 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    63
    60
    66
    63
    66
    Units: Unit on a Scale
    arithmetic mean (standard deviation)
        Day 8 (n=59, 55, 59, 58, 58)
    -4.9 ± 6.81
    -9.0 ± 7.13
    -9.2 ± 7.17
    -9.6 ± 8.16
    -8.3 ± 7.31
        Day 14 (n=63, 60, 66, 63, 66)
    -5.7 ± 7.75
    -10.8 ± 7.64
    -10.3 ± 7.39
    -9.5 ± 7.93
    -10.1 ± 8.06
    No statistical analyses for this end point

    Secondary: Change from Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System – Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14

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    End point title
    Change from Baseline in Impairment as Measured by Patient Reported Outcome Measurement Information System – Sleep Related Impairment (PROMIS-SRI) Total Score on Days 8 and 14
    End point description
    PROMIS for Sleep Related Impairment (PROMIS-SRI) scale consists of 8 items to evaluated daytime consequences on functioning on 5-point Likert scales. PROMIS-SRI measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Each question has five response options ranging in value from 1-5. To find total raw score for a short form with all questions answered, sum values of response to each question. For 8-item form, lowest possible raw score is 8; highest possible raw score is 40. Higher score indicates greater sleep impairment. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 8 and 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    61
    59
    63
    62
    65
    Units: Unit on a Scale
    arithmetic mean (standard deviation)
        Day 8 (n=57, 54, 55, 51, 54)
    -4.0 ± 6.56
    -7.0 ± 6.15
    -5.5 ± 6.55
    -8.8 ± 7.09
    -4.9 ± 6.98
        Day 14 (n=61, 59, 63, 62, 65)
    -5.2 ± 6.88
    -9.1 ± 6.53
    -6.3 ± 6.94
    -7.8 ± 6.98
    -7.4 ± 6.35
    No statistical analyses for this end point

    Secondary: Change from Baseline in Subjects's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale on Day 14

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    End point title
    Change from Baseline in Subjects's Assessment of Insomnia Severity Using the Patient Global Impression - Severity (PGI-S) Scale on Day 14
    End point description
    The PGI-S is a self-report scale to measure severity of illness (1=no insomnia, 2=very mild, 3=mild, 4=moderate, 5=severe, 6=very severe). Considering all aspects of insomnia, subjects were rated their severity on the PGI-S scale. Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    59
    59
    65
    62
    65
    Units: Unit on a Scale
        median (full range (min-max))
    0.00 (-5.0 to 2.0)
    -1.00 (-4.0 to 2.0)
    -1.00 (-4.0 to 1.0)
    -1.00 (-5.0 to 1.0)
    -1.00 (-4.0 to 1.0)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Subject's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale on Day 14

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    End point title
    Change from Baseline in Subject's Assessment of Improvement in Insomnia Using the Patient Global Impression - Improvement (PGI-I) Scale on Day 14
    End point description
    PGI-I is a self-report scale to measure improvement in illness (1=very much improved, 2=much improved, 3=improved [just enough to make a difference], 4=no change, 5=worse [just enough to make a difference], 6=much worse, 7=very much worse). Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    60
    62
    69
    65
    67
    Units: Units on a Scale
        median (full range (min-max))
    3.00 (0.0 to 5.0)
    2.00 (0.0 to 5.0)
    2.00 (0.0 to 4.0)
    2.00 (0.0 to 4.0)
    2.00 (0.0 to 5.0)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Response During on Insomnia Severity Index (ISI) Total Score on Day 14

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    End point title
    Percentage of Subjects Who Achieved Response During on Insomnia Severity Index (ISI) Total Score on Day 14
    End point description
    Percentage (%) of Responders defined as at least 50% reduction from baseline in ISI total score were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, total score ranges from 0-28. Negative changes in scores indicate improvement. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28). FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Subjects with missing values at a given time point are imputed as non-responders for that time point.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    74
    71
    73
    Units: Percentage of subjects
        number (not applicable)
    21.3
    40.8
    31.1
    33.8
    41.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Response During on Insomnia Severity Index (ISI) Total Score on Day 14 – Observed Case

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    End point title
    Percentage of Subjects Who Achieved Response During on Insomnia Severity Index (ISI) Total Score on Day 14 – Observed Case
    End point description
    % of Responders defined as at least 50% reduction from baseline in ISI total score were reported. It is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems; distress caused by sleep difficulties. 5-point Likert scale (0-4) was used to rate each item, total score ranges from 0-28. Negative changes in scores indicate improvement. Total score interpreted insomnia as follows: absence (0-7); sub-threshold (8-14); moderate (15-21); severe (22-28). FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number subjects evaluable for this endpoint. Subjects with missing values at a given time point are excluded from frequency calculation for that time point.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    69
    69
    73
    69
    70
    Units: Percentage of Subjects
        number (not applicable)
    23.2
    42.0
    31.5
    34.8
    42.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Remission During on Insomnia Severity Index (ISI) Total Score on Day 14

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    End point title
    Percentage of Subjects Who Achieved Remission During on Insomnia Severity Index (ISI) Total Score on Day 14
    End point description
    Percentage of subjects with remission of insomnia symptom defined as, total score of less than or equal to (<=) 10 on ISI scale. ISI is a 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. A 5-point Likert scale (0-4) is used to rate each item, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28). Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Subjects with missing values at a given time point are imputed as non-remitters for that time point.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    71
    74
    71
    73
    Units: Percentage of subjects
        number (not applicable)
    22.7
    42.3
    36.5
    38.0
    47.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Achieved Remission During on Insomnia Severity Index (ISI) Total Score on Day 14 – Observed Case

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    End point title
    Percentage of Subjects Who Achieved Remission During on Insomnia Severity Index (ISI) Total Score on Day 14 – Observed Case
    End point description
    % of subjects with remission of insomnia symptom defined as, total score of <= 10 on ISI scale. ISI is 7-item questionnaire assessing nature, severity, impact of insomnia. Dimensions evaluated are: severity of sleep onset, sleep maintenance, early morning awakening problems; sleep dissatisfaction; interference of sleep problem with daytime functioning; noticeability of sleep problems by others; distress caused by sleep difficulties. 5-point Likert scale (0-4) is used to rate each item, total score ranging from 0-28 and interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); severe insomnia (22-28). FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Subjects with missing values at a given time point are excluded from the frequency calculation for that time point.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    69
    69
    73
    69
    70
    Units: Percentage of Subjects
        number (not applicable)
    24.6
    43.5
    37.0
    39.1
    50.0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Total Score on Day 14

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    End point title
    Change from Baseline in Clinician's Assessment of Insomnia Severity Using the Clinical Global Impression - Severity (CGI-S) Total Score on Day 14
    End point description
    The CGI-S is a 7-point scale to measure severity of illness (1=normal [not at all ill], 2=borderline ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill patients). Higher score indicates more severity. Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    69
    69
    73
    69
    70
    Units: Units on a scale
    median (full range (min-max))
        Compared with Placebo
    0.0 (-5 to 1)
    -1.0 (-5 to 3)
    -1.0 (-5 to 2)
    -1.0 (-5 to 1)
    -1.0 (-5 to 0)
        Compared with Zolpidem
    0.0 (-5 to 1)
    -1.0 (-5 to 3)
    -1.0 (-5 to 2)
    -1.0 (-5 to 1)
    -1.0 (-5 to 0)
    No statistical analyses for this end point

    Secondary: Change from Baseline in in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Total Score on Day 14

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    End point title
    Change from Baseline in in Clinician's Assessment of Insomnia Improvement Using Clinical Global Impression-Improvement (CGI-I) Total Score on Day 14
    End point description
    The CGI-I is a 7-point scale to measure improvement in illness (1=very much improved, 2=much improved, 3=minimally improved, 4=no change from baseline, 5=minimally worse, 6=much worse, 7=very much worse). Higher score indicates more severity. Negative changes in scores indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    69
    69
    73
    69
    70
    Units: Units on a Scale
    median (full range (min-max))
        Compared with Placebo
    3.0 (1 to 5)
    3.0 (1 to 5)
    3.0 (1 to 4)
    3.0 (1 to 5)
    2.0 (1 to 5)
        Compared with Zolpidem
    3.0 (1 to 5)
    3.0 (1 to 5)
    3.0 (1 to 4)
    3.0 (1 to 5)
    2.0 (1 to 5)
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

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    End point title
    Number of Subjects with Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
    End point description
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAE defined as the number of subjects who experience at least 1 occurrence of the given event summarized by system organ class, preferred term, and treatment group. Safety analysis set (SAS) included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Up to Day 17
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    72
    73
    71
    73
    Units: Subjects
    37
    29
    23
    21
    31
    No statistical analyses for this end point

    Secondary: Number of Subjects with Treatment-Emergent Serious Adverse Events and Events of Special Interest

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    End point title
    Number of Subjects with Treatment-Emergent Serious Adverse Events and Events of Special Interest
    End point description
    TEAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly, is a suspected transmission of any infectious agent via a medicinal product and events of special interest include: Cataplexy; Sleep paralysis; Complex sleep-related behaviors such as confusional arousals, somnambulism (sleep walking), sleep terrors, bruxism (teeth grinding), sleep sex, sleep related eating disorder, sleep behavior disorder, and catathrenia (REM-associated end-inspiratory apnea/breath holding); Abnormal dreams; Falls. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Up to Day 17
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    72
    73
    71
    73
    Units: Subjects
        Treatment-emergent Serious AE
    0
    0
    0
    1
    1
        Events of Special Interest
    2
    1
    2
    1
    4
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Vital Signs and Physical Abnormalities

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    End point title
    Number of Subjects With Clinically Significant Vital Signs and Physical Abnormalities
    End point description
    Abnormally low parameters include pulse (bpm)- Decrease value from baseline greater than or equal to (>=) 15 to <=50; Systolic BP (mmHg [Millimetre of mercury])- Decrease value from baseline >=20 to <=90; Diastolic BP- decrease value from baseline >=15 to <=50; weight (Kilogram[Kg])- Decrease from baseline >=7%; Body temperature (Celsius [C])- <35.5; Abnormally high parameters include pulse- increase value from baseline >=15 to >=100; Systolic BP(mmHg)- Increase from baseline of >=20 to >=180; Diastolic BP- increase value from baseline>=15 to >=105; weight(Kg)- increase from baseline of >=7%; body temperature (C)- >37.5. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Up to Day 15
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    75
    72
    73
    71
    73
    Units: Subjects
        Supine Pulse Rate: Abnormally low
    2
    2
    2
    3
    0
        Supine Pulse Rate: Abnormally high
    1
    0
    0
    0
    1
        Standing Pulse Rate: Abnormally low
    1
    0
    0
    1
    1
        Standing Pulse Rate: Abnormally high
    8
    7
    3
    6
    11
        Supine Systolic BP: Abnormally low
    3
    0
    3
    2
    2
        Supine Systolic BP: Abnormally high
    1
    0
    0
    0
    0
        Standing Systolic BP: Abnormally low
    2
    1
    1
    3
    5
        Standing Systolic BP: Abnormally high
    2
    0
    0
    0
    0
        Supine Diastolic BP: Abnormally low
    2
    0
    0
    0
    4
        Supine Diastolic BP: Abnormally high
    0
    1
    0
    0
    1
        Standing Diastolic BP: Abnormally low
    0
    1
    0
    1
    0
        Standing Diastolic BP: Abnormally high
    0
    0
    0
    0
    1
        Temperature: Abnormally low
    2
    3
    0
    3
    2
        Temperature: Abnormally high
    1
    0
    0
    2
    1
        Weight: Abnormally low
    0
    0
    0
    1
    0
        Weight: Abnormally high
    2
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Electrocardiogram (ECG) Abnormalities

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    End point title
    Number of Subjects With Clinically Significant Electrocardiogram (ECG) Abnormalities
    End point description
    Twelve-lead ECGs was recorded in a supine position and different ECG intervals (RR, PR, QRS, and QT) and heart rate was measured. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points. Here, bpm indicates beats per minute. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Up to Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    74
    69
    73
    68
    71
    Units: Subjects
        Heart rate: <=50 bpm (n=74, 70, 71, 68, 71)
    10
    7
    5
    6
    6
        Heart rate:>=100 bpm (n=74, 70, 71, 68, 71)
    0
    0
    0
    0
    0
        PR interval: <=120 msec (n=74, 69, 71, 68, 71)
    0
    0
    0
    1
    0
        PR interval: >=200 msec (n=74, 70, 71, 68, 71)
    4
    4
    4
    2
    7
        QRS interval: <=60 msec (n=74, 70, 71, 68, 71)
    0
    0
    0
    0
    0
        QRS interval: >=120 msec (n=74, 70, 71, 68, 71)
    0
    0
    0
    0
    0
        QT interval: <=200 msec (n=74, 70, 71, 68, 71)
    0
    0
    0
    0
    0
        QT interval: >=500 msec (n=74, 70, 71, 68, 71)
    1
    0
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Clinically Significant Laboratory Abnormalities

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    End point title
    Number of Subjects With Clinically Significant Laboratory Abnormalities
    End point description
    Number of subjects with clinically significant laboratory abnormalities was assessed. Blood samples for serum chemistry (albumin, alkaline phosphatase etc), hematology (hemoglobin, hematocrit, etc), and urinalysis (pH, specific gravity, etc) was collected for clinical laboratory testing. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses. Here, Abn., ALT , AST, GGT signifies abnormally, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase respectively.
    End point type
    Secondary
    End point timeframe
    Up to Day 15
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    69
    72
    73
    68
    71
    Units: Subjects
        ALT: Abnormally high(n=69, 70, 69, 67, 71)
    0
    0
    0
    0
    0
        Albumin: Abnormally low (n=69, 70, 71, 68, 71)
    0
    0
    0
    0
    0
        Albumin: Abnormally high (n=69, 70, 71, 68, 71)
    0
    0
    0
    0
    0
        Alkaline Phosphatase: Abn. high(n=69,70,70,68,71)
    0
    0
    0
    0
    0
        AST: Abnormally high (n=69, 70, 69, 67, 71)
    0
    0
    0
    0
    0
        Bicarbonate: Abnormally low (n=69, 70, 69, 67, 71)
    0
    0
    0
    0
    0
        Bicarbonate: Abn. high (n=69, 70, 69, 67, 71)
    0
    0
    0
    0
    0
        Bilirubin: Abnormally high (n=69, 70, 69, 67, 71)
    0
    0
    0
    0
    0
        Calcium: Abnormally low (n=69, 70, 70, 68, 71)
    0
    0
    0
    0
    0
        Calcium: Abnormally high (n=69, 70, 70, 68, 71)
    0
    0
    0
    0
    0
        Chloride: Abnormally low (n=69, 70, 70, 68, 71)
    1
    0
    0
    0
    0
        Chloride: Abnormally high (n=69, 70, 70, 68, 71)
    0
    0
    0
    0
    0
        Creatine Kinase: Abn. high (n=69, 70, 69, 67, 71)
    0
    0
    0
    0
    0
        Creatinine: Abnormally high (n=69, 70, 70, 68, 71)
    0
    1
    0
    0
    0
        Direct Bilirubin: Abn. high (n=68, 70, 69, 66, 70)
    0
    0
    0
    0
    0
        GGT: Abnormally high (n=69, 70, 70, 68, 71)
    0
    0
    0
    0
    0
        Lactate Dehydrogenase: Abn. high(n=62,68,65,65,64)
    0
    0
    1
    0
    0
        Phosphate: Abnormally low (n=69, 70, 71, 68, 71)
    0
    0
    0
    0
    0
        Phosphate: Abnormally high (n=69, 70, 71, 68, 71)
    0
    0
    0
    0
    0
        Potassium: Abnormally low (n=69, 70, 70, 68, 71)
    0
    0
    0
    0
    0
        Potassium: Abnormally high(n=69, 70, 70, 68, 71)
    0
    0
    3
    1
    2
        Protein: Abnormally low (n=69, 70, 70, 68, 71)
    0
    1
    0
    0
    0
        Sodium: Abnormally low (n=69, 70, 70, 68, 71)
    0
    0
    0
    0
    0
        Sodium: Abnormally high (n=69, 70, 70, 68, 71)
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Suicidal Ideation as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Total Score

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    End point title
    Number of Subjects with Suicidal Ideation as Determined by Columbia Suicide Severity Rating Scale (C-SSRS) Total Score
    End point description
    C-SSRS is a questionnaire designed to solicit occurrence, severity, frequency of suicidal ideation/behaviors using following scores: Suicidal Ideation (1:Wish to be Dead; 2:Non-specific Active Suicidal Thoughts; 3:Active Suicidal Ideation with Any Methods without Intent to Act; 4:Active Suicidal Ideation with Some Intent to Act; 5:Active Suicidal Ideation with Specific Plan/Intent). Suicidal Behavior (6:Preparatory Acts; 7:Aborted Attempt; 8:Interrupted Attempt; 9:Actual Attempt; 10:Completed Suicide). If no events qualify for score of 1-10, score 0 indicate “no event that can be assessed on basis of C-SSRS”. Higher scores= greater severity. SAS included all subjects who were randomly assigned to drug and received at least 1 dose of drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. 1 subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Day 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    69
    72
    73
    69
    70
    Units: Subjects
        Score 0: No Event
    69
    72
    73
    69
    70
        Score 1: Wish to be Dead
    0
    0
    0
    0
    0
        Score 2: Non-Specific Active Suicidal Thoughts
    0
    0
    0
    0
    0
        Score 3: Suic Ideation Without Plan and Intent
    0
    0
    0
    0
    0
        Score 4: Suic Ideation Intent to Act Without Plan
    0
    0
    0
    0
    0
        Score 5: Suic Ideation With Plan and Intent
    0
    0
    0
    0
    0
        Score 6: Preparatory Acts or Behavior
    0
    0
    0
    0
    0
        Score 7: Aborted Attempt
    0
    0
    0
    0
    0
        Score 8: Interrupted Attempt
    0
    0
    0
    0
    0
        Score 9: Actual Attempt
    0
    0
    0
    0
    0
        Score 10: Completed Suicide
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14

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    End point title
    Change from Baseline in Karolinska Sleepiness Scale (KSS) Total Score on Days 2 and 14
    End point description
    The KSS is a patient reported assessment of level of drowsiness at the time of scale administration. This scale is focused mainly on the propensity to fall asleep and has a high validity in measuring sleepiness. It consists of a 9-point Likert scale with response options from: 1=very alert, 3=alert, 5=neither alert nor sleepy, 7=sleepy (but not fighting sleep), 9=very sleepy (fighting sleep). SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Baseline, Days 2 and 14
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    66
    62
    65
    59
    67
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        Day 2 (n=66, 61, 65, 59, 67)
    0.3 ± 1.75
    -0.4 ± 1.86
    -0.2 ± 1.42
    -0.5 ± 1.86
    -0.4 ± 1.68
        Day 14 (n=63, 62, 62, 59, 65)
    0.1 ± 1.82
    -0.8 ± 2.15
    -0.6 ± 1.72
    -0.7 ± 1.90
    -0.7 ± 2.01
    No statistical analyses for this end point

    Secondary: Next-Day Residual Effects Measured by Postural Stability (Body Sway)

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    End point title
    Next-Day Residual Effects Measured by Postural Stability (Body Sway)
    End point description
    The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. Body sway is measured using an ataxiameter. Subjects were instructed to wear a pair of thin socks for each session. Before starting a measurement, subjects were asked to stand still and comfortable, with their feet approximately 10 centimeters (cm) apart and their hands in a relaxed position alongside the body and eyes closed. The total period of body sway measurement was 2 minutes. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Day 14 (morning)
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    66
    66
    69
    67
    69
    Units: 1/3 Degree Angle of Arc
        arithmetic mean (standard deviation)
    -0.06 ± 17.15
    3.14 ± 16.14
    -0.87 ± 15.62
    -0.25 ± 14.71
    1.65 ± 14.11
    No statistical analyses for this end point

    Secondary: Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)

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    End point title
    Change From Baseline in Power of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
    End point description
    Power of Attention is a combination of the speed scores from the three tests of attention, and is established to reflect the ability to focus attention and to process information. Larger scores reflect poorer ability. The sum of the reaction time measures from the attentional tasks (Simple Reaction Time, Choice Reaction Time and Digit Vigilance Speed). SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14 (Morning)
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    67
    66
    68
    67
    69
    Units: millisecond (ms)
        arithmetic mean (standard deviation)
    35.88 ± 125.43
    48.59 ± 137.75
    67.09 ± 257.67
    37.07 ± 124.23
    35.38 ± 189.99
    No statistical analyses for this end point

    Secondary: Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)

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    End point title
    Change From Baseline in Continuity of Attention as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
    End point description
    Continuity of Attention is a combination of the speed scores from the Choice Reaction Time and Digit Vigilance tasks and reflects the ability to sustain attention over time. Smaller scores indicate poorer ability. The sum of the accuracy measures from the attentional tasks (Choice Reaction Time and Digit Vigilance Accuracy) minus Digit Vigilance False Alarms (errors). SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14 (Morning)
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    67
    66
    68
    67
    69
    Units: Number
        arithmetic mean (standard deviation)
    0.36 ± 5.31
    -0.20 ± 3.16
    -1.37 ± 6.35
    0.10 ± 5.05
    -0.39 ± 5.14
    No statistical analyses for this end point

    Secondary: Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)

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    End point title
    Change From Baseline in Quality of Working Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
    End point description
    Quality of working memory is a combination of the scores from Spatial Working Memory and Numeric Working Memory tasks, and is established to reflect the ability to temporarily hold numeric and spatial information in memory. Smaller scores reflect poorer ability. The sum of Spatial and Numeric Working Memory sensitivity indices (accuracy). SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14 (Morning)
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    67
    65
    68
    67
    69
    Units: Number
        arithmetic mean (standard deviation)
    0.00 ± 0.35
    -0.03 ± 0.28
    -0.02 ± 0.41
    -0.04 ± 0.29
    -0.05 ± 0.28
    No statistical analyses for this end point

    Secondary: Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)

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    End point title
    Change From Baseline in Quality of Episodic Secondary Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
    End point description
    Quality of Episodic Secondary Memory is a combination of accuracy measures from Word Recognition, Immediate Word Recall and Delayed Word Recall tasks and reflects the ability to store and retrieve information in episodic memory. Smaller scores reflect poorer ability. The sum of accuracy measures from the Immediate and Delayed Word Recall tasks, adjusted for errors, and from the word and picture recognition tasks. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject is summarized under the 5 mg dose group.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14 (Morning)
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    66
    65
    68
    66
    67
    Units: Number
        arithmetic mean (standard deviation)
    -22.84 ± 53.73
    -23.15 ± 46.02
    -33.58 ± 48.82
    -25.45 ± 56.37
    -37.96 ± 55.94
    No statistical analyses for this end point

    Secondary: Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)

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    End point title
    Change From Baseline in Speed of Memory as Measured by a Computerized Battery of Cognitive Tests on Day 14 (Morning)
    End point description
    The sum of the speed measures from the two working memory tasks (Spatial and Numeric) and the two recognition tasks (Word and Picture). Speed of Memory combines reaction times from Spatial Working Memory, Numeric Working Memory, Word Recognition and Picture recognition tasks. This score measures memory retrieval speed. Larger scores reflect poorer ability. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Baseline and Day 14 (Morning)
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    67
    65
    68
    67
    69
    Units: millisecond
        arithmetic mean (standard deviation)
    -104.75 ± 787.74
    258.38 ± 719.56
    7.57 ± 806.27
    -65.67 ± 761.77
    -83.70 ± 1060.38
    No statistical analyses for this end point

    Secondary: Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary–Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), sTST

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    End point title
    Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 as Measured by the Consensus Sleep Diary–Morning Administration (CSD-M):Self-Reported Sleep-Onset Latency (sSOL), Subjective Wake After Sleep Onset (sWASO), sTST
    End point description
    CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to prior night's sleep. It allows for calculation of total time spent in bed and SE as percentage of time asleep out of amount of time spent in bed. Sleep quality and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 0 (very poor) to 4 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. Negative change in sSOL, sWASO indicate improvement and positive change in Subjective Total Sleep Time (sTST) indicates improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. Here, 'n' (number analyzed) signifies number of subjects who were evaluable at specified time points.
    End point type
    Secondary
    End point timeframe
    Day 14 to Day 17
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    63
    58
    67
    56
    58
    Units: Minutes
    arithmetic mean (standard deviation)
        sSOL (n=63, 58, 57,56,58)
    -20.56 ± 74.145
    -4.83 ± 43.769
    9.67 ± 29.798
    15.55 ± 32.327
    9.57 ± 72.253
        sWASO (n=57, 51, 52,51,51)
    -12.39 ± 57.711
    -0.76 ± 66.663
    -2.13 ± 41.505
    -10.80 ± 63.672
    3.76 ± 58.805
        sTST (n=63, 58, 57, 56, 58)
    30.95 ± 101.367
    13.07 ± 102.093
    6.96 ± 96.664
    19.71 ± 66.447
    -7.95 ± 102.183
    No statistical analyses for this end point

    Secondary: Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary–Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)

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    End point title
    Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary–Morning Administration: Subjective Refreshed Feeling on Waking (sFRESH) and Subjective Quality of Sleep (sQUAL)
    End point description
    CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE as the percentage of time asleep out of amount of time spent in bed. Sleep quality and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: sFRESH and sQUAL. Positive change in sFRESH and sQUAL indicates improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 14 to 17
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    63
    58
    57
    56
    58
    Units: Units on a Scale
    arithmetic mean (standard deviation)
        sFRESH
    0.13 ± 1.085
    0.17 ± 1.011
    0.04 ± 1.017
    0.11 ± 1.073
    -0.03 ± 0.898
        sQUAL
    0.19 ± 1.242
    0.24 ± 1.129
    -0.07 ± 1.083
    0.02 ± 1.120
    -0.12 ± 1.010
    No statistical analyses for this end point

    Secondary: Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary–Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW)

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    End point title
    Change in Subjective Sleep Parameters From Day 14 as Compared to Day 17 Using Consensus Sleep Diary–Morning Administration (CSD-M): Number of Nighttime Awakenings (s-nNAW)
    End point description
    CSD-M is a standardized subject diary based on expert consensus and qualitative subject input to retrieve patient reported subjective sleep parameters related to the prior night's sleep. It allows for calculation of total time spent in bed and SE (as the percentage of time asleep out of amount of time spent in bed). Sleep quality and how well rested subjects felt at awaking are rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher ratings indicate better sleep quality and more refreshing/restorative quality of sleep. CSD-M parameters analyzed includes: s-nNAW. Negative change in s-nNAW indicate improvement. FAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Day 14 to 17
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    63
    58
    57
    56
    58
    Units: Number of awakening
        arithmetic mean (standard deviation)
    0.16 ± 3.525
    -0.59 ± 2.009
    -0.35 ± 1.217
    -0.36 ± 1.052
    -0.34 ± 1.396
    No statistical analyses for this end point

    Secondary: Number of Subjects Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17

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    End point title
    Number of Subjects Withdrawal Symptoms of JNJ-42847922 as Measured by Physician Withdrawal Checklist (PWC) From Day 14 to Day 17
    End point description
    PWC-20 is a reliable, sensitive instrument used to assess potential withdrawal symptoms following cessation of treatment. Items are as follows: Loss of Appetite, Nausea-Vomiting, Diarrhea, Anxiety-Nervousness, Irritability, Dysphoric Mood-Depression, Insomnia, Fatigue, Poor Coordination, Restlessness, Diaphoresis, Tremor, Dizziness, Headaches, Stiffness, Weakness, Increased Acuity Sound Smell Touch (IASST), Paresthesias, Remember, Derealization. Each item score ranges from 0 (not present)-3 (severe), where higher scores = more affected condition. Total score ranges from 0-60 where higher score indicates more affected condition. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. 1 subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922 and was summarized under 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Day 14 to 17
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    69
    69
    70
    68
    69
    Units: Subjects
        Loss of Appetite: No Symptoms
    65
    69
    65
    68
    66
        Loss of Appetite: Improved Symptoms
    0
    0
    4
    0
    1
        Loss of Appetite: Symptoms Present and Unchanged
    0
    0
    0
    0
    0
        Loss of Appetite: New or Worsened Symptoms
    4
    0
    1
    0
    2
        Nausea-Vomiting: No Symptoms
    67
    67
    66
    67
    63
        Nausea-Vomiting: Improved Symptoms
    0
    1
    3
    0
    5
        Nausea-Vomiting: Symptoms Present and Unchanged
    0
    0
    0
    0
    1
        Nausea-Vomiting: New or Worsened Symptoms
    2
    1
    1
    1
    0
        Diarrhea: No Symptoms
    65
    69
    67
    67
    63
        Diarrhea: Improved Symptoms
    2
    0
    1
    1
    4
        Diarrhea: Symptoms Present and Unchanged
    0
    0
    1
    0
    0
        Diarrhea: New or Worsened Symptoms
    2
    0
    1
    0
    2
        Anxiety-Nervousness: No Symptoms
    64
    68
    64
    62
    62
        Anxiety-Nervousness:Improved Symptoms
    2
    1
    3
    3
    5
        Anxiety-Nervousness:Symptoms Present and Unchanged
    2
    0
    1
    2
    0
        Anxiety-Nervousness: New or Worsened Symptoms
    1
    0
    2
    1
    2
        Irritability: No Symptoms
    58
    58
    59
    60
    58
        Irritability:Improved Symptoms
    6
    9
    5
    4
    9
        Irritability:Symptoms Present and Unchanged
    3
    1
    3
    3
    0
        Irritability:New or Worsened Symptoms
    2
    1
    3
    1
    2
        Dysphoric Mood: No Symptoms
    66
    66
    68
    65
    66
        Dysphoric Mood: Improved Symptoms
    0
    3
    1
    1
    1
        Dysphoric Mood: Symptoms Present and Unchanged
    2
    0
    1
    1
    0
        Dysphoric Mood: New or Worsened Symptoms
    1
    0
    0
    1
    2
        Insomnia: No Symptoms
    12
    14
    11
    17
    16
        Insomnia: Improved Symptoms
    19
    15
    13
    11
    15
        Insomnia: Symptoms Present and Unchanged
    27
    28
    32
    28
    21
        Insomnia: New or Worsened Symptoms
    11
    12
    14
    12
    17
        Fatigue: No Symptoms
    30
    43
    41
    45
    44
        Fatigue: Improved Symptoms
    21
    15
    19
    8
    14
        Fatigue: Symptoms Present and Unchanged
    5
    7
    8
    9
    5
        Fatigue: New or Worsened Symptoms
    13
    4
    2
    6
    6
        Poor Coordination: No Symptoms
    61
    65
    63
    61
    61
        Poor Coordination: Improved Symptoms
    6
    3
    7
    5
    5
        Poor Coordination: Symptoms Present and Unchanged
    1
    1
    0
    1
    1
        Poor Coordination: New/Worsened Symptoms
    1
    0
    0
    1
    2
        Restlessness:No Symptoms
    55
    59
    59
    60
    60
        Restlessness:Improved Symptoms
    9
    6
    9
    5
    7
        Restlessness:Symptoms Present and Unchanged
    3
    2
    1
    1
    1
        Restlessness:New or Worsened Symptoms
    2
    2
    1
    2
    1
        Diaphoresis:No Symptoms
    64
    68
    65
    65
    64
        Diaphoresis:Improved Symptoms
    3
    1
    2
    2
    2
        Diaphoresis:Symptoms Present and Unchanged
    0
    0
    0
    0
    1
        Diaphoresis:New or Worsened Symptoms
    2
    0
    3
    1
    2
        Tremor: No Symptoms
    66
    68
    69
    68
    67
        Tremor: Improved Symptoms
    2
    0
    0
    0
    0
        Tremor: Symptoms Present and Unchanged
    0
    1
    0
    0
    0
        Tremor: New or Worsened Symptoms
    1
    0
    1
    0
    2
        Dizziness:No Symptoms
    63
    69
    66
    64
    60
        Dizziness: Improved Symptoms
    3
    0
    2
    3
    7
        Dizziness: Symptoms Present and Unchanged
    1
    0
    1
    1
    1
        Dizziness:New or Worsened Symptoms
    2
    0
    4
    0
    1
        Headaches:No Symptoms
    56
    51
    61
    60
    56
        Headaches:Improved Symptoms
    9
    12
    2
    7
    3
        Headaches:Symptoms Present and Unchanged
    2
    5
    3
    0
    3
        Headaches:New or Worsened Symptoms
    2
    1
    2
    1
    7
        Stiffness:No Symptoms
    59
    62
    64
    63
    59
        Stiffness:Improved Symptoms
    8
    2
    2
    3
    3
        Stiffness:Symptoms Present and Unchanged
    1
    2
    2
    0
    1
        Stiffness:New or Worsened Symptoms
    1
    3
    2
    2
    6
        Weakness:No Symptoms
    61
    69
    65
    65
    65
        Weakness:Improved Symptoms
    3
    0
    3
    3
    2
        Weakness:Symptoms Present and Unchanged
    3
    0
    1
    0
    0
        Weakness:New or Worsened Symptoms
    2
    0
    1
    0
    2
        IASST: No Symptoms
    64
    66
    66
    63
    62
        IASST: Improved Symptoms
    1
    1
    1
    3
    2
        IASST: Symptoms Present and Unchanged
    2
    1
    0
    0
    1
        IASST: New or Worsened Symptoms
    2
    1
    3
    2
    4
        Paresthesias:No Symptoms
    62
    68
    66
    68
    68
        Paresthesias:Improved Symptoms
    4
    0
    2
    0
    0
        Paresthesias:Symptoms Present and Unchanged
    1
    1
    0
    0
    0
        Paresthesias:New or Worsened Symptoms
    2
    0
    2
    0
    1
        Remember:No Symptoms
    50
    60
    56
    56
    53
        Remember:Improved Symptoms
    9
    7
    1
    8
    6
        Remember:Symptoms Present and Unchanged
    5
    1
    4
    1
    5
        Remember:New or Worsened Symptoms
    5
    1
    1
    3
    5
        Derealization:No Symptoms
    64
    68
    68
    67
    68
        Derealization:Improved Symptoms
    4
    1
    1
    1
    1
        Derealization:Symptoms Present and Unchanged
    0
    0
    0
    0
    0
        Derealization:New or Worsened Symptoms
    1
    0
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17

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    End point title
    Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) Total Score for Self-Assessment of Withdrawal Symptoms on Day 17
    End point description
    The BWSQ is a 20 symptom self-report questionnaire to investigate withdrawal symptoms. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. Subjects rate the degree to which they are experiencing each symptom as either "No," "Yes-moderate" or "Yes-severe". The questionnaire has been shown to be reliable and to have acceptable construct validity in assessing withdrawal symptoms. Total scores can range from 0-40 with higher scores indicating greater severity of symptoms. SAS included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. Here, N (number of subjects analyzed) signifies number of subjects evaluable for this endpoint. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    End point type
    Secondary
    End point timeframe
    Day 17
    End point values
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Number of subjects analysed
    58
    54
    56
    51
    55
    Units: Unit on a Scale
        arithmetic mean (standard deviation)
    1.5 ± 2.58
    1.2 ± 1.90
    2.0 ± 3.44
    1.5 ± 2.93
    2.0 ± 3.10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Day 17
    Adverse event reporting additional description
    Safety analysis set included all subjects who were randomly assigned to study drug and received at least 1 dose of study drug. One subject who was randomized to JNJ-42847922 10 mg dose group received 5 mg of JNJ-42847922. This subject was summarized under the 5 mg dose group for safety analyses.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo as 2 oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 5 mg
    Reporting group description
    Subjects received JNJ-42847922 5 milligram (mg) dose as two 2.5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 10 mg
    Reporting group description
    Subjects receive JNJ-42847922 10 mg as one 10 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    JNJ-42847922 20 mg
    Reporting group description
    Subjects received JNJ-42847922 20 mg as one 20 mg oral capsule and one placebo capsule for 14 consecutive nights from Day 1 to Day 14.

    Reporting group title
    Zolpidem
    Reporting group description
    Subjects received Zolpidem 5 mg as one 5 mg capsule plus one placebo capsule or 10 mg Zolpidem as two 5 mg oral capsules for 14 consecutive nights from Day 1 to Day 14.

    Serious adverse events
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    1 / 73 (1.37%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Cerebral Haemorrhage
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cognitive Disorder
         subjects affected / exposed
    0 / 75 (0.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo JNJ-42847922 5 mg JNJ-42847922 10 mg JNJ-42847922 20 mg Zolpidem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 75 (29.33%)
    16 / 72 (22.22%)
    10 / 73 (13.70%)
    13 / 71 (18.31%)
    21 / 73 (28.77%)
    Nervous system disorders
    Disturbance in Attention
         subjects affected / exposed
    4 / 75 (5.33%)
    2 / 72 (2.78%)
    1 / 73 (1.37%)
    1 / 71 (1.41%)
    4 / 73 (5.48%)
         occurrences all number
    4
    2
    1
    1
    4
    Dizziness
         subjects affected / exposed
    1 / 75 (1.33%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    0 / 71 (0.00%)
    5 / 73 (6.85%)
         occurrences all number
    1
    0
    0
    0
    7
    Headache
         subjects affected / exposed
    8 / 75 (10.67%)
    7 / 72 (9.72%)
    4 / 73 (5.48%)
    6 / 71 (8.45%)
    8 / 73 (10.96%)
         occurrences all number
    8
    8
    6
    8
    10
    Somnolence
         subjects affected / exposed
    1 / 75 (1.33%)
    1 / 72 (1.39%)
    0 / 73 (0.00%)
    4 / 71 (5.63%)
    4 / 73 (5.48%)
         occurrences all number
    1
    1
    0
    4
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 75 (10.67%)
    4 / 72 (5.56%)
    3 / 73 (4.11%)
    2 / 71 (2.82%)
    2 / 73 (2.74%)
         occurrences all number
    8
    4
    3
    2
    2
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 72 (0.00%)
    2 / 73 (2.74%)
    2 / 71 (2.82%)
    1 / 73 (1.37%)
         occurrences all number
    4
    0
    2
    2
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    3 / 75 (4.00%)
    0 / 72 (0.00%)
    0 / 73 (0.00%)
    1 / 71 (1.41%)
    4 / 73 (5.48%)
         occurrences all number
    4
    0
    0
    1
    4
    Nausea
         subjects affected / exposed
    2 / 75 (2.67%)
    1 / 72 (1.39%)
    2 / 73 (2.74%)
    0 / 71 (0.00%)
    5 / 73 (6.85%)
         occurrences all number
    2
    1
    2
    0
    5
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    3 / 75 (4.00%)
    1 / 72 (1.39%)
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    4 / 73 (5.48%)
         occurrences all number
    4
    1
    1
    0
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 75 (1.33%)
    4 / 72 (5.56%)
    1 / 73 (1.37%)
    0 / 71 (0.00%)
    1 / 73 (1.37%)
         occurrences all number
    1
    4
    1
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    4 / 75 (5.33%)
    0 / 72 (0.00%)
    1 / 73 (1.37%)
    1 / 71 (1.41%)
    0 / 73 (0.00%)
         occurrences all number
    4
    0
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2018
    The overall reason for the amendment is to update exclusion criteria, based on Health Authority request to ensure breastfeeding women are excluded from the study and to provide more detail on certain clinical conditions that are contra-indicated for zolpidem use.
    24 Apr 2018
    To add results of the male and female rat fertility studies; To exclude further enrollment of women of childbearing potential (WOCBP); In addition, other minor changes and clarifications related to study procedures were made.
    25 Jul 2018
    To remove the interim analysis from the protocol; To change a secondary objective to an exploratory objective; To change an exploratory correlation analysis; To clarify the inclusion criteria regarding the follicle stimulating hormone (FSH) level threshold for postmenopausal women and the time spent in bed as well as the exclusion criterion for the threshold of ECG abnormalities; To add abnormal (vivid) dreams as an adverse event of special interest; In addition, other minor changes and clarifications related to study procedures were made.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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