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

Phase 3

Completed

• Conditions: Insomnia
• Interventions: Drug: zolpidem tartrate sublingual tablet; Drug: Placebo

• Registration Number: NCT00466193
• Lead Sponsor: Transcept Pharmaceuticals

Brief Summary

The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-24
• Study First Submitted QC: 2007-04-24
• Study First Posted: 2007-04-27
• Study Start: 2007-05
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Results First Submitted: 2011-12-15
• Results First Submitted QC: 2011-12-15
• Results First Posted: 2012-01-20
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

• Adults with history of sleeplessness

Exclusion Criteria

• Allergic to investigational drug
• Any conditions and medications that may interfere with study drug evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zolpidem 3.5mg	zolpidem tartrate sublingual tablet	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline	Weeks -1 to 0	Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?
Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment	Weeks 1 to 4	Time was recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: How long did it take you to fall asleep after taking your study medication?

Secondary Outcome Measures

Name	Time	Method
Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline	Weeks -1 to 0	Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?
Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment	Weeks 1 to 4	Total sleep time in minutes after waking in the middle of the night. The values were recorded by participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how long did you sleep until you woke up this morning?
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.	Weeks -1 to 0	Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment	Weeks 1 to 4	Number of awakenings following middle-of-the-night awakening were recorded by study participants using a telephone interactive voice response system (IVRS) to answer the question: After you fell back to sleep, how many times did you wake up again before waking up in the morning?
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline	Weeks -1 to 0	The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during the baseline period. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment	Weeks 1 to 4	The number of minutes subjects reported being awake after onset of sleep following middle-of-the-night awakening during double-blind treatment. Values were recorded using a telephone interactive voice response system (IVRS) to answer the question: Considering all of these awakenings (after taking study medication and returning to sleep), how long were you awake from the time you went back to sleep after dosing until you got out of bed this morning?
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline	Weeks -1 to 0	Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). During the baseline period, all participants received placebo.
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment	Weeks 1 to 4	Morning sleepiness was assessed using a 9-point sleepiness scale (1=very sleepy to 9=wide awake and alert). Values are from dosing nights during double-blind treatment.

Trial Locations

Locations (1)

Transcept Investigational Site; 🇺🇸 Durham, North Carolina, United States