Long Term Treatment With Zolpidem - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

October 4, 2011

Start Date ^ICMJE

March 2005

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Sleep Latency [ Time Frame: Pre-Post and Post-Discontinuation ] [ Designated as safety issue: No ]

Sleep latency as assessed by sleep diary

Original Primary Outcome Measures ^ICMJE

Bi-weekly measures during 12 week follow-up for sleep diary measures of sleep latency, wake after sleep onset time, and total sleep time.
Bi-weekly measures during baseline and treatment for sleep diary measures of sleep latency, wake after sleep onset time, and total sleep time.

Change History

Complete list of historical versions of study NCT00156533 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

WASO [ Time Frame: Pre-post and post-discontinuation ] [ Designated as safety issue: No ]

Minutes of wake after sleep onset.

Original Secondary Outcome Measures ^ICMJE

weekly insomnia ratings
weekly sleepiness/fatigue ratings
weekly mood ratings
weekly medical symptoms checklist

Descriptive Information

Brief Title ^ICMJE

Long Term Treatment With Zolpidem

Official Title ^ICMJE

Long Term Treatment With Zolpidem: The Relative Efficacy of QHS & Intermittent Dosing and the Potential for Long Term Clinical Gains After Treatment Discontinuation.

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase IV

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Insomnia
Primary Insomnia
Psychophysiologic Insomnia

Intervention ^ICMJE

Drug: Zolpidem

10 mg of Zolpidem

Study Arms

Placebo Comparator: Placebo
QHS dosing with placebo

Intervention: Drug: Zolpidem
Active Comparator: QHS Zolpidem
QHS dosing with 10mg of zolpidem

Intervention: Drug: Zolpidem
Experimental: Intermittant Zolpidem
Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed

Intervention: Drug: Zolpidem
CTRL
Monitor only condition.

Intervention: Drug: Zolpidem

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00156533

Other Study ID Numbers ^ICMJE

PI Initiated, 11045

Has Data Monitoring Committee

Yes

Responsible Party

( University of Rochester )

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

Sanofi-Synthelabo

Investigators ^ICMJE

Principal Investigator:

Michael L Perlis, Ph.D.

University of Rochester

Information Provided By

University of Rochester

Verification Date

October 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP