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Completed

NCT Number: NCT00466193

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

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Transcept Investigational Site

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with history of sleeplessness

Exclusion criteria

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

Treatment and study plan

zolpidem tartrate sublingual tablet

Drug

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.

Other names: Intermezzo®

Placebo

Drug

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 outcomes

  1. Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline

    Time frame: 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?

  2. Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment

    Time frame: 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 outcomes

  1. Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline

    Time frame: 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?

  2. Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment

    Time frame: 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?

  3. Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline.

    Time frame: 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?

  4. Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment

    Time frame: 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?

  5. Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline

    Time frame: 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?

  6. Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment

    Time frame: 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?

  7. Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline

    Time frame: 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.

  8. Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Transcept Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 27, 2007
Registry last updated
Feb 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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