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

Insomnia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466193
• Other study ID #: ZI-12
• Status: Completed
• Phase: Phase 3
• First received: April 24, 2007
• Last updated: February 10, 2012
• Start date: May 2007
• Est. completion date: November 2007

Study information

• Verified date: February 2012
• Source: Transcept Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• zolpidem tartrate sublingual tablet
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.
• Placebo
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.

Locations

Country	Name	City	State
United States	Transcept Investigational Site	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Transcept Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?	Weeks -1 to 0	No
Primary	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?	Weeks 1 to 4	No
Secondary	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?	Weeks -1 to 0	No
Secondary	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?	Weeks 1 to 4	No
Secondary	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?	Weeks -1 to 0	No
Secondary	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?	Weeks 1 to 4	No
Secondary	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?	Weeks -1 to 0	No
Secondary	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?	Weeks 1 to 4	No
Secondary	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.	Weeks -1 to 0	No
Secondary	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.	Weeks 1 to 4	No