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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380081
Recruitment Status : Completed
First Posted : September 25, 2006
Results First Posted : January 20, 2012
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
Transcept Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.

Condition or disease Intervention/treatment Phase
Insomnia Drug: zolpidem tartrate sublingual tablet 3.5mg Drug: zolpidem tartrate sublingual tablet 1.75mg Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2006
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: placebo/zolpidem 3.5/zolpidem 1.75 Drug: zolpidem tartrate sublingual tablet 3.5mg
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 Name: Intermezzo®

Drug: zolpidem tartrate sublingual tablet 1.75mg
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 Name: Intermezzo®

Drug: Placebo
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.
Experimental: placebo/zolpidem 1.75/zolpidem 3.5 Drug: zolpidem tartrate sublingual tablet 3.5mg
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 Name: Intermezzo®

Drug: zolpidem tartrate sublingual tablet 1.75mg
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 Name: Intermezzo®

Drug: Placebo
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.
Experimental: zolpidem 3.5/placebo/zolpidem 1.75 Drug: zolpidem tartrate sublingual tablet 3.5mg
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 Name: Intermezzo®

Drug: zolpidem tartrate sublingual tablet 1.75mg
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 Name: Intermezzo®

Drug: Placebo
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.
Experimental: zolpidem 3.5/zolpidem 1.75/placebo Drug: zolpidem tartrate sublingual tablet 3.5mg
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 Name: Intermezzo®

Drug: zolpidem tartrate sublingual tablet 1.75mg
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 Name: Intermezzo®

Drug: Placebo
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.
Experimental: zolpidem 1.75/placebo/zolpidem 3.5 Drug: zolpidem tartrate sublingual tablet 3.5mg
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 Name: Intermezzo®

Drug: zolpidem tartrate sublingual tablet 1.75mg
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 Name: Intermezzo®

Drug: Placebo
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.
Experimental: zolpidem 1.75/zolpidem 3.5/placebo Drug: zolpidem tartrate sublingual tablet 3.5mg
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 Name: Intermezzo®

Drug: zolpidem tartrate sublingual tablet 1.75mg
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 Name: Intermezzo®

Drug: Placebo
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380081


Sponsors and Collaborators
Transcept Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Thomas Roth, PhD Henry Ford Hospital, Sleep Disorders and Research Center
Principal Investigator: Martin Scharf, PhD Tri-State Sleep Disorders Center
More Information
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Responsible Party: Transcept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00380081    
Other Study ID Numbers: ZI-06-010
First Posted: September 25, 2006    Key Record Dates
Results First Posted: January 20, 2012
Last Update Posted: February 14, 2012
Last Verified: February 2012
Keywords provided by Transcept Pharmaceuticals:
Insomnia
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Sleep Aids, Pharmaceutical
 Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action