Back to resultsA Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
Primary Purpose
Insomnia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
zolpidem tartrate sublingual tablet 3.5mg
zolpidem tartrate sublingual tablet 1.75mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Insomnia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
placebo/zolpidem 3.5/zolpidem 1.75
placebo/zolpidem 1.75/zolpidem 3.5
zolpidem 3.5/placebo/zolpidem 1.75
zolpidem 3.5/zolpidem 1.75/placebo
zolpidem 1.75/placebo/zolpidem 3.5
zolpidem 1.75/zolpidem 3.5/placebo
Arm Description
Outcomes
Primary Outcome Measures
Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
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
Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
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.
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
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.
Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening
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.
Subjective Sleep Quality Rating
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.
Subjective Level of Refreshed Sleep
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.
Subjective Ability to Function
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.
Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening
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.
Subjective Sleep Onset Latency After Middle-of-the-Night Awakening
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.
Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening
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.
Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening
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.
Polysomnography Number of Awakenings After Middle-of-the-Night Awakening
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.
Full Information
NCT ID
NCT00380081
First Posted
September 21, 2006
Last Updated
February 10, 2012
Sponsor
Transcept Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00380081
Brief Title
A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
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 Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (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 this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet 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
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo/zolpidem 3.5/zolpidem 1.75
Arm Type
Experimental
Arm Title
placebo/zolpidem 1.75/zolpidem 3.5
Arm Type
Experimental
Arm Title
zolpidem 3.5/placebo/zolpidem 1.75
Arm Type
Experimental
Arm Title
zolpidem 3.5/zolpidem 1.75/placebo
Arm Type
Experimental
Arm Title
zolpidem 1.75/placebo/zolpidem 3.5
Arm Type
Experimental
Arm Title
zolpidem 1.75/zolpidem 3.5/placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
zolpidem tartrate sublingual tablet 3.5mg
Other Intervention Name(s)
Intermezzo®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
zolpidem tartrate sublingual tablet 1.75mg
Other Intervention Name(s)
Intermezzo®
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography
Description
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.
Time Frame
Days 1 and 2 for each treatment
Secondary Outcome Measure Information:
Title
Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Subjective Sleep Quality Rating
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Subjective Level of Refreshed Sleep
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Subjective Ability to Function
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Polysomnography Sleep Efficiency After Scheduled Middle-of-the-Night Awakening
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Subjective Sleep Onset Latency After Middle-of-the-Night Awakening
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Polysomnography Wake Time After Sleep Onset Following Middle-of-the-Night Awakening
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Subjective Wake Time After Sleep Onset After Middle-of-the-Night Awakening
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Polysomnography Number of Awakenings After Middle-of-the-Night Awakening
Description
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.
Time Frame
Days 1 and 2 for each treatment
Other Pre-specified Outcome Measures:
Title
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia
Description
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.
Time Frame
Days 1 and 2 for each treatment
Title
Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia
Description
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.
Time Frame
Days 1 and 2 for each treatment
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Roth, PhD
Organizational Affiliation
Henry Ford Hospital, Sleep Disorders and Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Scharf, PhD
Organizational Affiliation
Tri-State Sleep Disorders Center
Official's Role
Principal Investigator
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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