Long Term Treatment With Zolpidem

Condition(s) targeted: Insomnia; Primary Insomnia; Psychophysiologic Insomnia

Intervention: zolpidem (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Rochester

Official(s) and/or principal investigator(s):
Michael L Perlis, Ph.D., Principal Investigator, Affiliation: University of Rochester

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.

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.

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

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.

Secondary outcome:

weekly insomnia ratings

weekly sleepiness/fatigue ratings

weekly mood ratings

weekly medical symptoms checklist

Minimum age: 25 Years. Maximum age: 55 Years. Gender(s): Both.

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

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

Click here to learn more about our research.

Click here to learn more about our sleep laboratory.

Starting date: March 2005
Ending date: February 2008
Last updated: April 21, 2008