A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia
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
1 other identifier
interventional
82
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2006
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 21, 2006
CompletedFirst Posted
Study publicly available on registry
September 25, 2006
CompletedResults Posted
Study results publicly available
January 20, 2012
CompletedFebruary 14, 2012
February 1, 2012
3 months
September 21, 2006
December 15, 2011
February 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Days 1 and 2 for each treatment
Secondary Outcomes (11)
Number of Treatment Responders Based on Polysomnography Latency to Persistent Sleep After Middle-of-the-Night Awakening
Days 1 and 2 for each treatment
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography
Days 1 and 2 for each treatment
Average Subjective Total Sleep Time After Scheduled Middle-of-the-Night Awakening
Days 1 and 2 for each treatment
Subjective Sleep Quality Rating
Days 1 and 2 for each treatment
Subjective Level of Refreshed Sleep
Days 1 and 2 for each treatment
- +6 more secondary outcomes
Other Outcomes (2)
Total Sleep Time After Scheduled Middle-of-the-Night Awakening Measured by Polysomnography for Participants With More Severe Insomnia
Days 1 and 2 for each treatment
Latency to Persistent Sleep After Middle-of-the-Night Awakening as Measured by Polysomnography for a Subpopulation of Participants With More Severe Insomnia
Days 1 and 2 for each treatment
Study Arms (6)
placebo/zolpidem 3.5/zolpidem 1.75
EXPERIMENTALplacebo/zolpidem 1.75/zolpidem 3.5
EXPERIMENTALzolpidem 3.5/placebo/zolpidem 1.75
EXPERIMENTALzolpidem 3.5/zolpidem 1.75/placebo
EXPERIMENTALzolpidem 1.75/placebo/zolpidem 3.5
EXPERIMENTALzolpidem 1.75/zolpidem 3.5/placebo
EXPERIMENTALInterventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Scheduled nocturnal awakening is an established method used to evaluate treatments for naturally occurring middle-of-the-night awakenings. Additional studies are needed to determine the generalizability of the findings to 'real world' conditions.
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Purdue Pharma LP
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Roth, PhD
Henry Ford Hospital, Sleep Disorders and Research Center
- PRINCIPAL INVESTIGATOR
Martin Scharf, PhD
Tri-State Sleep Disorders Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2006
First Posted
September 25, 2006
Study Start
April 1, 2006
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
February 14, 2012
Results First Posted
January 20, 2012
Record last verified: 2012-02