A Study of Zolpidem Tartrate Sublingual Tablet in Adult Patients With Insomnia - Full Text View

Sponsor:	Transcept Pharmaceuticals
Information provided by (Responsible Party):	Transcept Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00466193

Purpose

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

Condition	Intervention	Phase
Insomnia	Drug: zolpidem tartrate sublingual tablet Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by Transcept Pharmaceuticals:

Primary Outcome Measures:

Latency to Sleep Onset After Middle-of-the-Night Awakening at Baseline [ Time Frame: Weeks -1 to 0 ] [ Designated as safety issue: No ]
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?
Latency to Sleep Onset After Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ] [ Designated as safety issue: No ]
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 Outcome Measures:

Subjective Total Sleep Time Following Middle-of-the-Night Awakening at Baseline [ Time Frame: Weeks -1 to 0 ] [ Designated as safety issue: No ]
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?
Subjective Total Sleep Time Following Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ] [ Designated as safety issue: No ]
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?
Subjective Number of Awakenings Following Middle-of-the-Night Awakening at Baseline. [ Time Frame: Weeks -1 to 0 ] [ Designated as safety issue: No ]
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?
Subjective Number of Awakenings Following Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ] [ Designated as safety issue: No ]
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?
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening at Baseline [ Time Frame: Weeks -1 to 0 ] [ Designated as safety issue: No ]
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?
Subjective Wake Time After Sleep Onset Following Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ] [ Designated as safety issue: No ]
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?
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening at Baseline [ Time Frame: Weeks -1 to 0 ] [ Designated as safety issue: No ]
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.
Morning Sleepiness Rating Following Dosing Post Middle-of-the-Night Awakening During Double-blind Treatment [ Time Frame: Weeks 1 to 4 ] [ Designated as safety issue: No ]
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.

Enrollment:	295
Study Start Date:	May 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zolpidem 3.5mg	Drug: zolpidem tartrate sublingual tablet 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 Name: Intermezzo®
Placebo Comparator: Placebo	Drug: Placebo 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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with history of sleeplessness

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466193

Locations

United States, North Carolina
Transcept Investigational Site
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Transcept Pharmaceuticals

Investigators

Principal Investigator:	Andrew Krystal, MD	Clinical Neurophysiology Training Program, Duke University
Principal Investigator:	Thomas Roth, PhD	Sleep Disorders and Research Center, Henry Ford Hospital

More Information

No publications provided

Responsible Party:	Transcept Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00466193 History of Changes
Other Study ID Numbers:	ZI-12
Study First Received:	April 24, 2007
Results First Received:	December 15, 2011
Last Updated:	December 15, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Transcept Pharmaceuticals:

Insomnia

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012