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

Sponsor:	Transcept Pharmaceuticals
Information provided by:	Transcept Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00380081

Purpose

The purpose of this study is to evaluate sleep onset following administration of TransOral zolpidem versus placebo in adult insomnia patients.

Condition	Intervention	Phase
Insomnia	Drug: Zolpidem 3.5 Drug: Zolpidem 1.75 Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of the Efficacy and Safety of Sublingual Zolpidem Tartrate Lozenge in Adult Patients With Insomnia Characterized by Difficulty Returning to Sleep After Middle-of-the-Night (MOTN) Awakening

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:

Average latency to persistent sleep after middle-of-the-night awakening [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Average total sleep time [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]
Average sleep efficiency [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]
Sleep quality rating [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]
Average sleep onset latency [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]
Average subjective total sleep time [ Time Frame: 6 nights total (2 nights for each of the 3 treatments) ] [ Designated as safety issue: No ]

Enrollment:	82
Study Start Date:	April 2006
Study Completion Date:	July 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo/zolpidem 3.5/zolpidem 1.75: Experimental	Drug: Zolpidem 3.5 Zolpidem 3.5 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Zolpidem 1.75 Zolpidem 1.75 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Placebo Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.
placebo/zolpidem 1.75/zolpidem 3.5: Experimental	Drug: Zolpidem 3.5 Zolpidem 3.5 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Zolpidem 1.75 Zolpidem 1.75 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Placebo Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.
zolpidem 3.5/placebo/zolpidem 1.75: Experimental	Drug: Zolpidem 3.5 Zolpidem 3.5 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Zolpidem 1.75 Zolpidem 1.75 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Placebo Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.
zolpidem 3.5/zolpidem 1.75/placebo: Experimental	Drug: Zolpidem 3.5 Zolpidem 3.5 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Zolpidem 1.75 Zolpidem 1.75 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Placebo Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.
zolpidem 1.75/placebo/zolpidem 3.5: Experimental	Drug: Zolpidem 3.5 Zolpidem 3.5 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Zolpidem 1.75 Zolpidem 1.75 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Placebo Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.
zolpidem 1.75/zolpidem 3.5/placebo: Experimental	Drug: Zolpidem 3.5 Zolpidem 3.5 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Zolpidem 1.75 Zolpidem 1.75 milligram sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved. Drug: Placebo Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Patients placed the study drug under the tongue until it dissolved.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
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
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380081

Sponsors and Collaborators

Transcept Pharmaceuticals

Investigators

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

No publications provided

Responsible Party:	Transcept ( Chief Medical Consultant )
Study ID Numbers:	ZI-06-010
Study First Received:	September 21, 2006
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00380081 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Transcept Pharmaceuticals:

Insomnia

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Zolpidem
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Depressants
Dyssomnias
Sleep Disorders

Pharmacologic Actions
Sleep Disorders, Intrinsic
Mental Disorders
Therapeutic Uses
GABA Agonists
Hypnotics and Sedatives
GABA Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010