Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia

• Sponsor: Sunovion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00856973
• Collaborator: (none)
• Enrollment: 486
• Locations: 73
• Arms: 3
• Duration (Months): 26
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

Condition or Disease	Intervention/Treatment	Phase
Insomnia; Attention Deficit Hyperactivity Disorder	Drug: eszopiclone; Drug: eszopiclone; Drug: Placebo	Phase 3

Detailed Description

This is a multi center, randomized, double blind, placebo controlled, fixed dose study of eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17 years) or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Design

• Study Type: Interventional
• Actual Enrollment: 486 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Placebo Controlled, Double Blind, Fixed Dose Study of the Efficacy and Safety of Eszopiclone in Children (6 to 11 Years) and Adolescents (12 to 17 Years) With Attention Deficit/Hyperactivity Disorder Associated Insomnia
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose eszopiclone 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Drug: eszopiclone; 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
Experimental: High dose eszopiclone 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	Drug: eszopiclone; 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
Placebo Comparator: Placebo Placebo 6-17 years	Drug: Placebo; 1 tablet per day for 12 weeks

Outcome Measures

Primary Outcome Measures

1. Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS). [Baseline (Day 0) to Week 12]

   A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.

Secondary Outcome Measures

1. Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO) [Baseline (Day 0) to Week 12]

   A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.

2. Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12 [Baseline (Day 0) to Week 12]

   The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject's parent or caregiver and represented their assessment of severity and improvement in the subject's symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).

3. Change From Baseline in CGI-Child at Week 12 [Baseline (Day 0) to Week 12]

   The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject's assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).

4. Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale. [Baseline (Day 0) to Week 12]

   The Conners' 3 -Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners' 3 -Parent Short Form was a subset of items from the full-length form, and included the Conners' 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].

5. Change From Baseline to Week 12 in Subjective SL (Sleep Latency) [Baseline (Day 0) to Week 12]

   A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.

6. Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO). [Baseline (Day 0) to Week 12]

   A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.

7. Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE) [Baseline (Day 0) to Week 12]

   A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.

8. Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO). [Baseline (Day 0) to Week 12]

   A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject's sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.

9. Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST) [Baseline (Day 0) to Week 12]

   A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.

10. Change From Baseline to Week 12 in Subjective Total Sleep Time (TST). [Baseline (Day 0) to Week 12]

    A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.

11. Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population. [Baseline (Day 0) to Week 11]

    A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.

12. Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population. [Baseline (Day 0) to Week 11]

    A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.

13. Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population. [Baseline (Day 0) to Week 11]

    A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.

14. Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score. [Baseline (Day 0) to Week 12]

    The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.

15. Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score. [Baseline (Day 0) to Week 12]

    These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.

16. Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10). [Baseline (Day 0) to Week 12]

    The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.

17. Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO). [Baseline (Day 0) to Week 12]

    A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.

18. Change in School Tardiness/Attendance Reports at Week 12 (Days) [Baseline (Day 0) to Week 12]

    School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.

19. Change in School Tardiness/Attendance Reports at Week 12 (Hours) [Baseline (Day 0) to Week 12]

    School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is male or female 6 to 17 years of age, inclusive, at the time of consent.

• Subject must have a diagnosis of ADHD as defined by DSM-IV criteria

• Subject must have documented ADHD associated insomnia, defined as the subject or subject's parent/legal guardian having reported repeated difficulty with sleep initiation (sleep latency >30 minutes) or consolidation, (wake time after sleep onset

45 minutes) despite adequate age appropriate time and opportunity for sleep.

• Subject's Baseline PSG must reveal either >30 minutes latency to persistent sleep (LPS) or >45 minutes wake after sleep onset (WASO).

• Subject or subject's parent/legal guardian should have reported daytime functional impairment as a result of sleep problems.

• Subject or subject's parent/legal guardian should have reported attempted and failed behavioral interventions for sleep problems, including a regular bedtime and rise time

• Subject's sleep disturbance must not be attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication whether it is being used as intended or in an illicit manner.(Female subjects ≥8 years of age must have a negative serum pregnancy test)

• Subject must be in general good health

• Subject must be able to swallow tablets.

• If subject is currently taking medication for ADHD, they must be on a stable dose and regimen for a minimum of 1 month prior to the time of consent

Exclusion Criteria:

• Subject with weight <10th percentile for age and gender

• Subject has any clinically significant or unstable medical illness/abnormality or chronic disease.

• Subject has a documented history of Bipolar I or II Disorder, major depression, conduct disorder, generalized anxiety disorder or any history of psychosis.

• Subject has periodic limb movement >5 times per hour, as demonstrated on Baseline PSG.

• Subject has sleep disordered breathing, as demonstrated on Baseline PSG.

• Subject has another primary sleep disorder, a secondary sleep disorder, or any other known or suspected medical or psychiatric condition that has affected or may affect sleep

• Subject has a history of circadian rhythm disorder or will travel across ≥3 time zones more than once during the study.

• Subject has organic brain disease, or a history of febrile seizures.

• Subject is, in the opinion of the investigator, at suicidal or homicidal risk.

• Female subject who is pregnant or lactating or planning to become pregnant.

• Subject has taken any psychotropic medication without an appropriate washout period (≥5 half-lives) prior to randomization.

• Subject has a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.

• Subject has a history of allergic reaction or has a known or suspected sensitivity to racemic zopiclone, eszopiclone, or any substance that is contained in the formulation.

• Subject has a history of alcohol or substance abuse within 3 months of study participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sleep Disorders Center of Alabama	Birmingham	Alabama	United States	35213
2	Dothan Behavioral Medicine Clinic	Dothan	Alabama	United States	36303
3	Metropolitan Neuro Behavioral Institute	Chandler	Arizona	United States	85226
4	PsyPharma Clinical Research	Phoenix	Arizona	United States	85050
5	REM Medical Clinical Research	Tucson	Arizona	United States	85712
6	Paul E. Wylie	Little Rock	Arkansas	United States	72211
7	AV Institute, Inc.	Carson	California	United States	90746
8	Clinical Innovations, Inc.	Costa Mesa	California	United States	92626
9	Avastra Clinical Trials	Fountain Valley	California	United States	92708
10	Behavioral Research Specialists, LLC	Glendale	California	United States	91204
11	Pacific Institute for Medical Research Inc	Los Angeles	California	United States	90024
12	Excell Research, Inc.	Oceanside	California	United States	92056
13	North County Clinical Research (NCCR)	Oceanside	California	United States	92056
14	Pacific Clinical Research Medical Group	Orange	California	United States	92868
15	SDS Clinical Trials	Orange	California	United States	92868
16	California Clinical Trials Medical Group	Paramount	California	United States	90723
17	Clinical Innovations, Inc.	Riverside	California	United States	92506
18	Artemis Institute for Clinical Research	San Diego	California	United States	92123
19	Clinical Innovations, Inc.	San Diego	California	United States	92128
20	Neuropsychiatric Research Center of Orange County	Santa Ana	California	United States	92701
21	Clinical Innovations, Inc.	Santa Ana	California	United States	92705
22	Elite Clinical Trials	Wildomar	California	United States	92595
23	Delta Waves, INC	Colorado Springs	Colorado	United States	80918
24	Sarkis Clinical Trials	Gainesville	Florida	United States	32607
25	MD Clinical	Hallandale Beach	Florida	United States	33009
26	Florida Clinical Research Center LLC	Maitland	Florida	United States	32751
27	Florida Institute for Clinical Research, LLC	Orlando	Florida	United States	32822
28	SomnoMedics, LLC	Tampa	Florida	United States	33607
29	Pediatric Epilepsy and Neurology Specialists	Tampa	Florida	United States	33609
30	Neuro Trials Research, Inc.	Atlanta	Georgia	United States	30342
31	Sleep Disorders Center of Georgia	Atlanta	Georgia	United States	30342
32	Mountain West Clinical Trials	Eagle	Idaho	United States	83616
33	Alexian Brothers Center for Psychiatric Research	Hoffman Estates	Illinois	United States	60169
34	AMR Baber Research Inc.	Naperville	Illinois	United States	60563
35	American Medical Research, Inc.	Oak Brook	Illinois	United States	60523
36	Davis Clinic	Indianapolis	Indiana	United States	46260
37	Goldpoint Clinical Research	Indianapolis	Indiana	United States	46260
38	Psychiatric Associates	Overland Park	Kansas	United States	66211
39	Pedia Research LLC	Owensboro	Kentucky	United States	42301
40	Louisiana Research Associates, Inc.	New Orleans	Louisiana	United States	70114
41	Clinical Insights	Glen Burnie	Maryland	United States	21061
42	Neurocare, Inc.	Newton	Massachusetts	United States	02459
43	Neurobehavioral Medicine Group	Bloomfield Hills	Michigan	United States	48302
44	Mid-Michigan Sleep Center	Grand Blanc	Michigan	United States	48439
45	Clinical Neurophysiology Services, P.C.	Troy	Michigan	United States	48085
46	Midwest Research Group	St. Charles	Missouri	United States	63301
47	Premier Psychiatric Research Institute, LLC	Lincoln	Nebraska	United States	68510
48	Clinical Research Center of Nevada	Henderson	Nevada	United States	89015
49	Center for Psychiatry and Behavioral Medicine, Inc.	Las Vegas	Nevada	United States	89128
50	CRI Worldwide, LLC	Willingboro	New Jersey	United States	08046
51	Synergy Clinical Research Center	Farmingdale	New York	United States	11735
52	Tristate Sleep Disorders Center	Cincinnati	Ohio	United States	45246
53	MD & Associates, Inc.	Garfield Heights	Ohio	United States	44125
54	IPS Reserach Company	Oklahoma City	Oklahoma	United States	73103
55	Pahl Pharmaceutical Professionals, LLC	Oklahoma City	Oklahoma	United States	73112
56	Cutting Edge Research Group	Oklahoma City	Oklahoma	United States	73116
57	Eminence Research, LLC	Oklahoma City	Oklahoma	United States	73139
58	Tulsa Clinical Research	Tulsa	Oklahoma	United States	74104
59	Paradigm Research Professional, LLP	Tulsa	Oklahoma	United States	74114
60	Cyn3rgy Research	Gresham	Oregon	United States	97030
61	Oregon Center for Clinical Investigations, Inc.	Portland	Oregon	United States	97210
62	CRI Worldwide	Philadelphia	Pennsylvania	United States	19139
63	Carolina Clinical Trials Inc.	Charleston	South Carolina	United States	29405
64	InSite Clinical Research LLC	DeSoto	Texas	United States	75115
65	Claghorn-Lesem Research Clinic	Houston	Texas	United States	77008
66	Allegiant Clinical Research, LLC	Houston	Texas	United States	77024
67	MD	Houston	Texas	United States	77042
68	Todd J. Swick, MD, PA	Houston	Texas	United States	77063
69	MD	Lubbock	Texas	United States	79423
70	The Mech Center	Plano	Texas	United States	75024
71	Aspen Clinical Research, LLC	Orem	Utah	United States	84058
72	Northwest Clinical Research Center	Bellevue	Washington	United States	98007
73	Eastside Therapeutic Resource	Kirkland	Washington	United States	98033

Sponsors and Collaborators

• Sunovion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunovion
• ClinicalTrials.gov Identifier: NCT00856973
• Other Study ID Numbers: 190-246
• First Posted: Mar 6, 2009
• Last Update Posted: Jun 17, 2013
• Last Verified: May 1, 2013

• Keywords provided by Sunovion: Hypnotic; Eszopiclone; Attention Deficit/Hyperactivity Disorder; Insomnia; Children; Adolescent; Polysomnography; Actigraphy
• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Hyperkinesis; Disease; Attention Deficit Disorder with Hyperactivity; Eszopiclone

Study Results

Participant Flow

Pre-assignment Detail	Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of participants in the Baseline Characteristics refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period. Three subjects did not receive study medication.

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years
Period Title: Overall Study
STARTED	162	163	161
COMPLETED	126	122	123
NOT COMPLETED	36	41	38

Baseline Characteristics

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo	Total
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily. This included only patients that were randomized (ITT population).	1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily. This includes only patients that were randomized (ITT population).	Placebo Once Daily. This included only patients that were randomized (ITT population).	Total of all reporting groups
Overall Participants	160	163	160	483
Age (Count of Participants)
<=18 years	160 100%	163 100%	160 100%	483 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	00 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	11.3 (3.0)	11.4 (3.0)	11.6 (3.0)	11.5 (3.0)
Sex: Female, Male (Count of Participants)
Female	56 35%	60 36.8%	59 36.9%	175 36.2%
Male	104 65%	103 63.2%	101 63.1%	308 63.8%
Region of Enrollment (participants) [Number]
United States	160 100%	163 100%	160 100%	483 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).
Description	A central scoring facility was used to derive the PSG sleep parameters Latency to Persistent Sleep (LPS) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in LPS was derived from Week 12 LPS subtracted by BL LPS. Latency to persistent sleep (LPS; minutes): time from lights out to the first of 20 consecutive epochs (10 minutes) of non-wake, as determined by PSG recordings.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population with both baseline and week 12 LPS. ITT refers to only the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years
Measure Participants	123	122	121
Least Squares Mean (Standard Error) [minutes]	-18.33 (3.91)	-23.45 (3.91)	-25.66 (3.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pooled High Dose Eszopiclone, Placebo
	Comments	This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment grou
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANCOVA
	Comments	Bonferroni adjustment was use for multiple comparisons
Method of Estimation	Estimation Parameter	LS Mean Treatment Difference
	Estimated Value	7.33
	Confidence Interval	(2-Sided) 97.5%; -5.17 to 19.83
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.91
	Estimation Comments	Difference calculated as Eszopiclone minus placebo

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pooled Low Dose Eszopiclone, Placebo
	Comments	This endpoint was analyzed using ANCOVA with treatment group (pooled low dose eszopiclone, pooled high dose eszopiclone, and placebo) as a fixed effect and the baseline value as a covariate. Contrast statements were used to perform pairwise comparisons of the eszopiclone treatment groups to placebo. A Bonferroni adjustment was used for the 2 pairwise comparisons. Least squares means and the standard errors were presented for each treatment group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS Mean Treatment Difference
	Estimated Value	2.21
	Confidence Interval	(2-Sided) 97.5%; -10.23 to 14.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.91
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline (Day 0) to Week 12 in PSG Defined Wake Time After Sleep Onset (WASO)
Description	A central scoring facility was used to derive the PSG sleep parameters Wake Time After Sleep Onset (WASO) from the epochs and stages collected via the PSG recordings. Each epoch is 30 seconds. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Change from BL at Week 12 in WASO was derived from Week 12 WASO subtracted by BL WASO. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 WASO

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	123	122	121
Least Squares Mean (Standard Error) [Minutes]	-23.35 (3.40)	-16.75 (3.41)	-17.30 (3.43)

3. Secondary Outcome

Title	Change From Baseline in Clinical Global Improvement (CGI)-Parent/Caregiver at Week 12
Description	The CGI-I Parent/Caregiver was completed by the investigator based on interviews and interactions with the subject's parent or caregiver and represented their assessment of severity and improvement in the subject's symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with Week 12 CGI Improvement from Parent/Caregiver

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	126	123	121
Least Squares Mean (Standard Error) [Units on a scale]	2.3 (0.1)	2.6 (0.1)	2.7 (0.1)

4. Secondary Outcome

Title	Change From Baseline in CGI-Child at Week 12
Description	The CGI - I Child was completed by the investigator based on interviews and interactions with the subject and represented the subject's assessment of improvement in his/her symptoms since the start of the study. A 7 point scale was used for improvement with numeric values assigned to each of the responses: very much improved (1), much improved (2), minimally improved (3), no change (4), minimally worse (5), much worse (6), and very much worse (7).
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with Week 12 CGI Improvement from Child

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	126	123	121
Least Squares Mean (Standard Error) [Units on a scale]	2.3 (0.1)	2.5 (0.1)	2.7 (0.1)

5. Secondary Outcome

Title	Change From Baseline (Day 0) to Week 12 in Conners' ADHD Inattention Rating Scale.
Description	The Conners' 3 -Parent Short Form was completed by the parent and provided an assessment of Attention-Deficit/ Hyperactivity Disorder (ADHD) and the most common comorbid problems and disorders in children and adolescents. It is a multi-informant assessment of children and adolescents between 6 and 18 years of age that took into account home, social and school settings. The short version of the Conners' 3 -Parent Short Form was a subset of items from the full-length form, and included the Conners' 3 Content Scales of Inattention, Hyperactivity/Impulsivity, Learning Problems, Executive Functioning, Aggression, and Peer/Family Relations. The scale scores were presented as standardized age and gender based t scores. Inattention score was used for this endpoint. The lowest scale score is 40 (best) and the highest is 90 (worse)].
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 Conners' ADHD Inattention rating scale

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	126	122	120
Least Squares Mean (Standard Error) [units on a scale]	-8.8 (1.0)	-5.8 (1.0)	-7.1 (1.0)

6. Secondary Outcome

Title	Change From Baseline to Week 12 in Subjective SL (Sleep Latency)
Description	A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of SL over a pre-defined time period. SL is subjective time to fall asleep.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 Subjective sleep latency

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	122	121	121
Least Squares Mean (Standard Error) [Minutes]	0.5 (1.1)	0.6 (1.1)	0.6 (1.1)

7. Secondary Outcome

Title	Change From Baseline to Week 12 in Subjective Wake Time After Sleep Onset (WASO).
Description	A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of WASO over a pre-defined time period. WASO is the aggregate duration of awakenings from the time subjects fall asleep until last awakening. Wake time after sleep onset (WASO; minutes): The number of wake epochs after the onset of persistent sleep to the end of the recording, divided by 2.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 subjective WASO

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	122	122	120
Least Squares Mean (Standard Error) [Minutes]	0.2 (1.2)	0.3 (1.2)	0.3 (1.2)

8. Secondary Outcome

Title	Change From Baseline to Week 12 in PSG Defined Sleep Efficiency (SE)
Description	A central scoring facility was used to derive the PSG sleep parameter of Sleep Efficiency (SE) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Sleep efficiency: (total sleep time)/(total recording time) x 100. For this endpoint, total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 PSG defined sleep efficiency

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	124	122	121
Least Squares Mean (Standard Error) [percentage of SE]	7.31 (1.07)	7.40 (1.08)	7.94 (1.08)

9. Secondary Outcome

Title	Change From Baseline to Week 12 in PSG Defined Number of Awakenings After Sleep Onset (NAASO).
Description	A central scoring facility was used to derive the PSG sleep parameter of Number of Awakenings after Sleep Onset (NAASO). The PSG parameters provided an objective assessment of the subject's sleep on a given night. Number of awakenings: The number of times, after onset of persistent sleep, that there was a wake entry of at least one-minute duration. Each awakening must have been separated by an epoch of non rapid eye movement (NREM) sleep stage 2, 3/4, or rapid eye movement (REM) sleep.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 PSG defined of Awakenings After Sleep Onset

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	123	122	121
Least Squares Mean (Standard Error) [Number of Awakenings after sleep onse]	-2.0 (0.4)	-1.5 (0.4)	-0.7 (0.4)

10. Secondary Outcome

Title	Change From Baseline to Week 12 in PSG Defined Total Sleep Time (TST)
Description	A central scoring facility was used to derive the PSG sleep parameter of Total Sleep Time (TST) from the epochs and stages collected via the PSG recordings. The PSG parameters provided an objective assessment of the subject's sleep on a given night. Total sleep time was defined as the number of non-wake epochs from the beginning of recording to the end of recording divided by 2. If total recording time was greater than 960 epochs (480 minutes), total sleep time was calculated from the PSG truncated at 480 minutes.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 PSG defined Total Sleep Time

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	124	122	121
Least Squares Mean (Standard Error) [Minutes]	36.90 (6.01)	37.78 (6.05)	35.38 (6.07)

11. Secondary Outcome

Title	Change From Baseline to Week 12 in Subjective Total Sleep Time (TST).
Description	A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of TST over a pre-defined time period. TST is subjective total sleep time.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 subjective Total Sleep Time

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	121	123	122
Least Squares Mean (Standard Error) [Minutes]	77.2 (8.0)	66.4 (8.0)	49.2 (8.0)

12. Secondary Outcome

Title	Change From Baseline to Week 11 in Subjective Sleep Latency (SL) Measured by Actigraphy Monitoring in the Actigraphy Population.
Description	A central scoring facility was used to derive the actigraphy sleep parameter of Sleep Latency (SL). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Time Frame	Baseline (Day 0) to Week 11

Outcome Measure Data

Analysis Population Description

The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	85	83	98
Least Squares Mean (Standard Error) [Minutes]	0.90 (1.12)	0.81 (1.12)	0.93 (1.13)

13. Secondary Outcome

Title	Change From Baseline to Week 11 in Subjective WASO From Actigraphy Population.
Description	A central scoring facility was used to derive the actigraphy sleep parameters Wake Time After Sleep Onset (WASO). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Time Frame	Baseline (Day 0) to Week 11

Outcome Measure Data

Analysis Population Description

Actigraphy population which included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily	1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily	Placebo once daily
Measure Participants	85	83	98
Least Squares Mean (Standard Error) [Minutes]	0.94 (1.06)	1.02 (1.06)	0.99 (1.07)

14. Secondary Outcome

Title	Change From Baseline to Week 11 in Total Sleep Time (TST) Measured by Actigraphy Monitoring in the Actigraphy Population.
Description	A central scoring facility was used to derive the actigraphy sleep parameter of Total Sleep Time (TST). Actigraphy data were used for additional efficacy evaluation as well as for the evaluation of rebound and withdrawal effects.
Time Frame	Baseline (Day 0) to Week 11

Outcome Measure Data

Analysis Population Description

The Actigraphy population included subjects in the ITT population for whom actigraphy data had been collected. All efficacy analyses of actigraphy data were performed using this population

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	85	83	98
Least Squares Mean (Standard Error) [Minutes]	-4.72 (8.38)	1.63 (8.28)	-6.02 (8.74)

15. Secondary Outcome

Title	Change From Baseline to Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score.
Description	The PDSS is a validated measure of excessive sleepiness specifically designed for use in school aged children. The scale allowed for measurement of sleepiness across several relatively sedentary activities and provided a means to unmask sleepiness that may not be recognized during more active situations. It consisted of 8 items that assessed the frequency of a sleep related behavior (eg, how often do you fall asleep or get drowsy during class periods; are you usually alert most of the day; how often do you think you need more sleep) using a 5-point Likert type scale (0 = never, 4 = always). All items were summed to obtain the PDSS total score. PDSS data were used for efficacy evaluation as well as for the evaluation of residual effects.The overall PDSS scores range from a low of 0 where the individual is endorsing each item at the lowest level of sleepiness to a high of 32 where the individual is endorsing each item at the highest level of sleepiness.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 in Pediatric Daytime Sleepiness Scale (PDSS) Total Score

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	126	120	121
Least Squares Mean (Standard Error) [units on a scale]	-4.5 (0.5)	-4.0 (0.5)	-3.5 (0.5)

16. Secondary Outcome

Title	Change From Baseline to Week 12 in Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score.
Description	These tests are standardized information processing tasks to assess recognition and recoding of sensory information. The subject was given 90 seconds to complete as many substitutions of symbols as possible according to a code provided on top of the sheet. The Coding Copy Subtest A was used for subjects 6-7 years of age and the Coding Copy Subtest B was used for subjects 8-16 years of age, and the DSST was used for subjects 17 years of age. The score is the number of squares filled in correctly. Individuals are measured against their own pre-treatment baseline to determine levels of impairment using the scaled score. Higher scores mean less impairment (or potentially improvement) as the number of correct substitutions generally improves as cognition improves. Scaled scores are used to account for age differences among test takers. Scaled scores range from 1 to 19, and higher scores indicate higher cognitive function.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 Coding Copy Subtest / Digit Symbol Substitution Test (DSST) Scaled Score

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	126	122	122
Least Squares Mean (Standard Error) [Score]	2.2 (3.3)	2.1 (3.9)	2.6 (5.3)

17. Secondary Outcome

Title	Change From Baseline to Week 12 in Pediatric Quality-of-Life Scale (Short Form-10).
Description	The SF 10 Health Survey for Children is a 10 item care-giver completed assessment designed to measure children's health-related quality of life. The scale asked questions about the child's physical wellness, feelings, behavior, and activities at school and with family and friends. The SF 10 Physical and Psychosocial summary measures were scored such that higher scores indicated more favorable functioning.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 Pediatric Quality-of-Life Scale (Short Form-10)

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	123	122	121
Physical	4.40 (0.64)	3.07 (0.64)	4.07 (0.65)
Psychosocial	2.234 (0.562)	1.347 (0.566)	-0.121 (0.569)

18. Secondary Outcome

Title	Change From Baseline to Week 12 in Subjective Number of Awakenings After Sleep Onset (NAASO).
Description	A Sponsor produced sleep questionnaire asked the subject or parent/guardian to report information about the subject's sleep and daytime functioning since the last visit. This questionnaire provided a subjective assessment of NAASO over a pre-defined time period.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population with both baseline and Week 12 Subjective Number of Awakenings After Sleep Onset (NAASO)

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	123	122	122
Least Squares Mean (Standard Error) [Number of Awakenings]	-1.1 (0.1)	-0.8 (0.1)	-1.0 (0.1)

19. Secondary Outcome

Title	Change in School Tardiness/Attendance Reports at Week 12 (Days)
Description	School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	160	163	160
Number of Days Tardy	-0.4 (0.1)	-0.2 (0.1)	-0.3 (0.1)
Number of Days of Partial Attendance	0.1 (0.1)	-0.2 (0.1)	-0.1 (0.1)
Number of Days Absent	0.0 (0.08)	-0.2 (1.2)	0.3 (2.0)

20. Secondary Outcome

Title	Change in School Tardiness/Attendance Reports at Week 12 (Hours)
Description	School tardiness/attendance reports were to be collected when subject was actively enrolled in school (fall and spring semesters only; summer school, camps or other school attendance was not recorded.) The School Tardiness Report captured the number of days that the subject was tardy to school, had partial attendance at school or was completely absent from school. Data were collected for the 30-day period prior to Baseline, 6-week period prior to Week 6, 6-week period prior to Week 12.
Time Frame	Baseline (Day 0) to Week 12

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Pooled High Dose Eszopiclone	Pooled Low Dose Eszopiclone	Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years	1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years	Placebo 6-17 years once daily
Measure Participants	160	163	160
Least Squares Mean (Standard Error) [Hours]	-0.10 (0.05)	-0.12 (0.05)	-0.12 (0.05)

Adverse Events

Adverse Event Reporting Description	Numbers provided in any of the rows in the participant flow section are for subjects who were randomized. Number of Participants at Risk in this adverse event section refers to the subjects who were randomized AND had taken at least one dose of study drug during the doubleblind treatment period.
Arm/Group Title	Pooled High Dose Eszopiclone		Pooled Low Dose Eszopiclone		Placebo
Arm/Group Description	2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years		1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years		Placebo 6-17 years once daily
All Cause Mortality
	Pooled High Dose Eszopiclone		Pooled Low Dose Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Pooled High Dose Eszopiclone		Pooled Low Dose Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/159 (1.3%)		0/163 (0%)		0/161 (0%)
Nervous system disorders
Sedation	1/159 (0.6%)	1	0/163 (0%)	0	0/161 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory distress	1/159 (0.6%)	1	0/163 (0%)	0	0/161 (0%)	0
Other (Not Including Serious) Adverse Events
	Pooled High Dose Eszopiclone		Pooled Low Dose Eszopiclone		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	72/159 (45.3%)		68/163 (41.7%)		55/161 (34.2%)
Gastrointestinal disorders
Abdominal pain upper	8/159 (5%)	14	6/163 (3.7%)	7	5/161 (3.1%)	5
Vomiting	5/159 (3.1%)	5	10/163 (6.1%)	10	3/161 (1.9%)	3
Nausea	7/159 (4.4%)	8	4/163 (2.5%)	6	6/161 (3.7%)	7
Diarrhoea	3/159 (1.9%)	3	4/163 (2.5%)	4	6/161 (3.7%)	6
Abdominal Discomfort	8/159 (5%)	8	4/163 (2.5%)	5	0/161 (0%)	0
Toothache	2/159 (1.3%)	2	4/163 (2.5%)	6	0/161 (0%)	0
General disorders
Pyrexia	8/159 (5%)	9	4/163 (2.5%)	5	5/161 (3.1%)	6
Irritability	0/159 (0%)	0	4/163 (2.5%)	4	0/161 (0%)	0
Infections and infestations
Upper respiratory tract infection	5/159 (3.1%)	7	13/163 (8%)	15	7/161 (4.3%)	7
Nasopharyngitis	6/159 (3.8%)	6	9/163 (5.5%)	9	7/161 (4.3%)	9
Paryngitis	0/159 (0%)	0	2/163 (1.2%)	2	4/161 (2.5%)	5
Urinary Tract Infection	4/159 (2.5%)	4	1/163 (0.6%)	1	1/161 (0.6%)	2
Nervous system disorders
Headache	22/159 (13.8%)	34	19/163 (11.7%)	27	19/161 (11.8%)	33
Dysgeusia	22/159 (13.8%)	22	8/163 (4.9%)	8	2/161 (1.2%)	2
Dizziness	13/159 (8.2%)	20	6/163 (3.7%)	6	3/161 (1.9%)	3
Somnolence	6/159 (3.8%)	7	4/163 (2.5%)	4	3/161 (1.9%)	7
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	3/159 (1.9%)	3	6/163 (3.7%)	9	4/161 (2.5%)	4
Cough	4/159 (2.5%)	4	3/163 (1.8%)	4	4/161 (2.5%)	4
Nasal Congestion	4/159 (2.5%)	5	1/163 (0.6%)	4	0/161 (0%)	0
Skin and subcutaneous tissue disorders
Rash	3/159 (1.9%)	3	4/163 (2.5%)	4	5/161 (3.1%)	5

Limitations/Caveats

Per protocol, study did not have PSG adaptation nights at baseline and contained one PSG assessment post randomization visit

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.