Back to resultsA Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
zolpidem tartrate sublingual tablet
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia
Eligibility Criteria
Inclusion Criteria:
- Adults with history of sleeplessness
Exclusion Criteria:
- Allergic to investigational drug
- Any conditions and medications that may interfere with study drug evaluation
Sites / Locations
- Transcept Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Zolpidem 3.5mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
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
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
Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
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
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.
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
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
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
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
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
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.
Full Information
NCT ID
NCT00466193
First Posted
April 24, 2007
Last Updated
February 10, 2012
Sponsor
Transcept Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00466193
Brief Title
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of the Zolpidem Tartrate Sublingual Tablet in Adult Subjects With Insomnia Characterized by Difficulty Returning to Sleep After Awakening in the Middle-of-the-Night (MOTN)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transcept Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zolpidem 3.5mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
zolpidem tartrate sublingual tablet
Other Intervention Name(s)
Intermezzo®
Intervention Description
3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
Primary Outcome Measure Information:
Title
Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline
Description
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?
Time Frame
Weeks -1 to 0
Title
Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment
Description
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?
Time Frame
Weeks 1 to 4
Secondary Outcome Measure Information:
Title
Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline
Description
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?
Time Frame
Weeks -1 to 0
Title
Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment
Description
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?
Time Frame
Weeks 1 to 4
Title
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.
Description
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?
Time Frame
Weeks -1 to 0
Title
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment
Description
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?
Time Frame
Weeks 1 to 4
Title
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline
Description
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?
Time Frame
Weeks -1 to 0
Title
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment
Description
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?
Time Frame
Weeks 1 to 4
Title
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline
Description
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.
Time Frame
Weeks -1 to 0
Title
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment
Description
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.
Time Frame
Weeks 1 to 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with history of sleeplessness
Exclusion Criteria:
Allergic to investigational drug
Any conditions and medications that may interfere with study drug evaluation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Krystal, MD
Organizational Affiliation
Clinical Neurophysiology Training Program, Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Roth, PhD
Organizational Affiliation
Sleep Disorders and Research Center, Henry Ford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transcept Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
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