Long Term Treatment With Zolpidem - Full Text View

Sponsor:	University of Rochester
Collaborator:	Sanofi-Synthelabo
Information provided by (Responsible Party):	University of Rochester
ClinicalTrials.gov Identifier:	NCT00156533

Purpose

We want to assess whether "how and when" one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.

Condition	Intervention	Phase
Insomnia Primary Insomnia Psychophysiologic Insomnia	Drug: Zolpidem	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Long Term Treatment With Zolpidem: The Relative Efficacy of QHS & Intermittent Dosing and the Potential for Long Term Clinical Gains After Treatment Discontinuation.

Resource links provided by NLM:

Drug Information available for: Zolpidem

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Sleep Latency [ Time Frame: Pre-Post and Post-Discontinuation ] [ Designated as safety issue: No ]
Sleep latency as assessed by sleep diary

Secondary Outcome Measures:

WASO [ Time Frame: Pre-post and post-discontinuation ] [ Designated as safety issue: No ]
Minutes of wake after sleep onset.

Enrollment:	20
Study Start Date:	March 2005
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo QHS dosing with placebo	Drug: Zolpidem 10 mg of Zolpidem
Active Comparator: QHS Zolpidem QHS dosing with 10mg of zolpidem	Drug: Zolpidem 10 mg of Zolpidem
Experimental: Intermittant Zolpidem Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed	Drug: Zolpidem 10 mg of Zolpidem
CTRL Monitor only condition.	Drug: Zolpidem 10 mg of Zolpidem

Eligibility

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Ages 25 - 55
a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.
Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD).
complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months.

Exclusion Criteria:

Unstable medical or psychiatric illness
Use of medication that may be "insomnogenic" or may be reduce the effectiveness of zolpidem (e.g. SSRI's, steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)
symptoms suggestive of sleep disorders other than insomnia
polysomnographic data indicating sleep disorders other than insomnia
Evidence of active illicit substance use or fitting criteria for ETOH abuse or dependence
inadequate language comprehension
pregnancy
first-degree relatives with bipolar disorder or schizophrenia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156533

Locations

United States, New York
University of Rochester Sleep Research Laboratory
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Sanofi-Synthelabo

Investigators

Principal Investigator:

Michael L Perlis, Ph.D.

University of Rochester

More Information

Additional Information:

Click here to learn more about our research. This link exits the ClinicalTrials.gov site

Click here to learn more about our sleep laboratory. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00156533 History of Changes
Other Study ID Numbers:	PI Initiated, 11045
Study First Received:	September 7, 2005
Last Updated:	October 4, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Insomnia
Sleep
zolpidem
Ambien
Hypnotics

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