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Completed

NCT Number: NCT00380081

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

The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Insomnia as defined by DSM-IV criteria and supported by subject diary
  • Male or female between the ages of 18-64 years
  • Body mass index (BMI) between 18-34 kg/m^2
  • Females of childbearing potential must use a medically acceptable method of contraception
  • Capable of understanding and willing to comply with study procedures and has provided informed consent

Exclusion criteria

  • Females who are pregnant, breast-feeding or have a positive pregnancy test
  • Any circadian rhythm disorder including planned travel across several time zones during the study period
  • Known hypersensitivity to Zolpidem
  • Has performed regular shift work with the past several months prior to screening
  • An acute clinically significant illness or surgery as determined by the PI within 30 days of screening
  • Patients that have used any central nervous system (CNS) medication or other medication known to impact the sleep/wake cycle
  • A history of psychiatric disorder as defined by DSM-IV
  • A history of drug addiction or alcohol abuse
  • Any current significant disease, unless adequately controlled with a protocol allowed medication
  • Known history of HIV or Hepatitis B or C
  • Patients who have received an investigational drug within several months of screening

Treatment and study plan

zolpidem tartrate sublingual tablet 3.5mg

Drug

Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment 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®

zolpidem tartrate sublingual tablet 1.75mg

Drug

Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment 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 administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment 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 Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography

    Time frame: Days 1 and 2 for each treatment

    Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period.

Secondary outcomes

  1. 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

    Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period. A participant was considered to be a responder if the time to return to persistent sleep was less than twenty minutes.

  2. Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography

    Time frame: Days 1 and 2 for each treatment

    Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period.

  3. Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening

    Time frame: Days 1 and 2 for each treatment

    The time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period was recorded by each participant using the Treatment Morning Sleep Questionnaire.

  4. Subjective Sleep Quality Rating

    Time frame: Days 1 and 2 for each treatment

    Sleep quality was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.

  5. Subjective Level of Refreshed Sleep

    Time frame: Days 1 and 2 for each treatment

    Level of refreshed sleep was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.

  6. Subjective Ability to Function

    Time frame: Days 1 and 2 for each treatment

    Ability to function was rated by participants for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire. The percentage of participants within each rating category is reported. The rating scale was poor, fair, good and excellent.

  7. Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening

    Time frame: Days 1 and 2 for each treatment

    Sleep efficiency is a measurement of the percentage of time asleep to the total time in bed. It was measured by polysomnography for each day of every two-day treatment period.

  8. Subjective Sleep Onset Latency After Middle-of-the-Night Awakening

    Time frame: Days 1 and 2 for each treatment

    Participants documented the time to return to sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period using the Treatment Morning Sleep Questionnaire.

  9. Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening

    Time frame: Days 1 and 2 for each treatment

    Amount of time awake after sleep onset following a middle-of-the-night awakening was measured by polysomnography for each day of every two-day treatment period.

  10. Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening

    Time frame: Days 1 and 2 for each treatment

    Amount of time awake after sleep onset following a middle-of-the-night awakening was recorded by participants using the Treatment Morning Sleep Questionnaire for each day of every two-day treatment period.

  11. Polysomnography Number of Awakenings After Middle-of-the-Night Awakening

    Time frame: Days 1 and 2 for each treatment

    Number of times a participant awoke following sleep onset after the middle-of-the-night awakening, as measured by polysomnography for each day of every two-day treatment period.

Other outcomes

  1. 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

    Polysomnography was used to measure the time from return to persistent sleep after a middle-of-the-night (MOTN) awakening until final awakening for each day of every two-day treatment period in the subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.

  2. 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

    Polysomnography was used to measure the time to return to persistent sleep after a middle-of-the-night (MOTN) awakening for each day of every two-day treatment period in a subpopulation of patients with greater than 60 minutes to fall asleep after a MOTN awakening at baseline.

Sponsors and collaborators

Lead sponsor

Transcept Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Crossover Study of the Efficacy and Safety of Sublingual Zolpidem Tartrate Tablet in Adult Patients With Insomnia Characterized by Difficulty Returning to Sleep After Middle-of-the-Night (MOTN) Awakening

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Sep 25, 2006
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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