A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia

This study has been completed.

Study NCT00380081 Information provided by Transcept Pharmaceuticals

First Received on September 21, 2006. Last Updated on February 10, 2012 History of Changes

Results First Received: December 15, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Insomnia
Interventions:	Drug: zolpidem tartrate sublingual tablet 3.5mg Drug: zolpidem tartrate sublingual tablet 1.75mg Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 83 patient volunteers were enrolled and of these, 82 patients were randomized, received at least 1 dose of study drug during the double-blind treatment period and were included in safety and efficacy analyses.

Reporting Groups

	Description
Placebo/Zolpidem 3.5/Zolpidem 1.75	Cross-over interventions administered in the order listed.
Placebo/Zolpidem 1.75/Zolpidem 3.5	Cross-over interventions administered in the order listed.
Zolpidem 3.5/Placebo/Zolpidem 1.75	Cross-over interventions administered in the order listed.
Zolpidem 3.5/Zolpidem 1.75/Placebo	Cross-over interventions administered in the order listed.
Zolpidem 1.75/Placebo/Zolpidem 3.5	Cross-over interventions administered in the order listed.
Zolpidem 1.75/Zolpidem 3.5/Placebo	Cross-over interventions administered in the order listed.

Participant Flow: Overall Study

	Placebo/Zolpidem 3.5/Zolpidem 1.75	Placebo/Zolpidem 1.75/Zolpidem 3.5	Zolpidem 3.5/Placebo/Zolpidem 1.75	Zolpidem 3.5/Zolpidem 1.75/Placebo	Zolpidem 1.75/Placebo/Zolpidem 3.5	Zolpidem 1.75/Zolpidem 3.5/Placebo
STARTED	14	13	13	15	13	14
COMPLETED	14	13	13	15	12	13
NOT COMPLETED	0	0	0	0	1	1
Withdrawal by Subject	0	0	0	0	1	0
Family Emergency	0	0	0	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Placebo/Zolpidem 3.5/Zolpidem 1.75	Cross-over interventions administered in the order listed.
Placebo/Zolpidem 1.75/Zolpidem 3.5	Cross-over interventions administered in the order listed.
Zolpidem 3.5/Placebo/Zolpidem 1.75	Cross-over interventions administered in the order listed.
Zolpidem 3.5/Zolpidem 1.75/Placebo	Cross-over interventions administered in the order listed.
Zolpidem 1.75/Placebo/Zolpidem 3.5	Cross-over interventions administered in the order listed.
Zolpidem 1.75/Zolpidem 3.5/Placebo	Cross-over interventions administered in the order listed.

Baseline Measures

	Placebo/Zolpidem 3.5/Zolpidem 1.75	Placebo/Zolpidem 1.75/Zolpidem 3.5	Zolpidem 3.5/Placebo/Zolpidem 1.75	Zolpidem 3.5/Zolpidem 1.75/Placebo	Zolpidem 1.75/Placebo/Zolpidem 3.5	Zolpidem 1.75/Zolpidem 3.5/Placebo	Total
Number of Participants [units: participants]	14	13	13	15	13	14	82
Age [units: participants]
<=18 years	0	0	0	0	0	0	0
Between 18 and 65 years	14	13	13	15	13	14	82
>=65 years	0	0	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	48.2 ± 10.21	47.2 ± 14.90	49.6 ± 10.74	45.0 ± 9.64	41.8 ± 13.33	43.5 ± 12.99	45.9 ± 11.97
Gender [units: participants]
Female	8	10	10	11	10	9	58
Male	6	3	3	4	3	5	24
Race/Ethnicity, Customized [units: participants]
Caucasian	8	8	7	6	7	6	42
Hispanic	1	0	1	0	0	0	2
Black	5	5	4	9	6	7	36
Asian/Pacific	0	0	1	0	0	1	2
Region of Enrollment [units: participants]
United States	14	13	13	15	13	14	82
Body Mass Index ^[1] [units: kilograms/square meters] Mean ± Standard Deviation	27.72 ± 3.494	27.10 ± 4.164	27.27 ± 4.164	27.43 ± 3.717	25.92 ± 4.393	26.84 ± 2.681	27.06 ± 3.718
Height [units: centimeters] Mean ± Standard Deviation	174.6 ± 9.353	166.4 ± 7.574	172.4 ± 10.740	167.2 ± 10.246	167.4 ± 8.775	169.8 ± 9.955	169.6 ± 9.700
Number of Nights with Middle of the Night Awakening ^[2] [units: number of nights] Mean ± Standard Deviation	9.3 ± 0.99	9.4 ± 1.19	8.9 ± 1.38	9.3 ± 0.98	9.3 ± 1.11	8.6 ± 1.50	9.1 ± 1.20
Weight [units: kilograms] Mean ± Standard Deviation	84.41 ± 11.409	75.10 ± 12.665	81.83 ± 17.816	77.46 ± 16.739	72.91 ± 14.421	77.50 ± 10.331	78.25 ± 14.249

[1]	Body mass index is an estimate of body fat based on body weight divided by height squared.
[2]	Number of nights with Middle of the Night (MOTN) Awakenings is based upon self-reports on more than or equal to 3 nights and completion of at least 7 days of the 10-day Screening Morning Sleep Diary.

Outcome Measures

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1. Primary:

Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography [ Time Frame: Days 1 and 2 for each treatment ]

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2. Secondary:

Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]

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3. Secondary:

Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography [ Time Frame: Days 1 and 2 for each treatment ]

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4. Secondary:

Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]

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5. Secondary:

Subjective Sleep Quality Rating [ Time Frame: Days 1 and 2 for each treatment ]

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6. Secondary:

Subjective Level of Refreshed Sleep [ Time Frame: Days 1 and 2 for each treatment ]

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7. Secondary:

Subjective Ability to Function [ Time Frame: Days 1 and 2 for each treatment ]

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8. Secondary:

Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]

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9. Secondary:

Subjective Sleep Onset Latency After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]

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10. Secondary:

Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]

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11. Secondary:

Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]

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12. Secondary:

Polysomnography Number of Awakenings After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]

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13. Other Pre-specified:

Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia [ Time Frame: Days 1 and 2 for each treatment ]

Show Outcome Measure 13

14. Other Pre-specified:

Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia [ Time Frame: Days 1 and 2 for each treatment ]

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15. Post-Hoc:

Subjective Number of Awakenings After Middle-of-the-Night Awakening [ Time Frame: Days 1 and 2 for each treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Sponsor agrees to review manuscripts within a reasonable period of time. If sponsor determines the publication included patentable subject matter, sponsor will be granted no less than 120 days to prepare patent applications.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Scheduled nocturnal awakening is an established method used to evaluate treatments for naturally occurring middle-of-the-night awakenings. Additional studies are needed to determine the generalizability of the findings to 'real world' conditions.

Results Point of Contact:

Name/Title: Clinical Leader
Organization: Purdue Pharma LP
phone: 800-733-1333

No publications provided

Responsible Party:	Transcept Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00380081 History of Changes
Other Study ID Numbers:	ZI-06-010
Study First Received:	September 21, 2006
Results First Received:	December 15, 2011
Last Updated:	February 10, 2012
Health Authority:	United States: Food and Drug Administration