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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
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

42847922ISM2005

ISRCTN number

US NCT number

NCT03375203

WHO universal trial number (UTN)

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

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

03 Apr 2019

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

03 Apr 2019

Was the trial ended prematurely?

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

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 285

Country: Number of subjects enrolled

Belgium: 9

Country: Number of subjects enrolled

France: 1

Country: Number of subjects enrolled

Germany: 43

Country: Number of subjects enrolled

Japan: 21

Country: Number of subjects enrolled

Poland: 5

Worldwide total number of subjects

364

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

238

From 65 to 84 years

126

85 years and over

Subject disposition

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Recruitment details

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 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

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.

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.

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.

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.

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
Adverse event, non-fatal	2	3	-	1	2
Non-compliance with study drug	1	-	-	-	-
Adverse event, serious non-fatal	-	-	-	1	-
Withdrawal by subject	3	-	1	-	2
Protocol deviation	-	-	1	-	-

Baseline characteristics

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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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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

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

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

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

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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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 name

MedDRA

Dictionary version

21.1

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
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
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
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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Were there any global substantial amendments to the protocol? Yes

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.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

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

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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)

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)

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)

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)

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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