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

Further Study Details: 

Primary Outcomes: 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 Outcomes: weekly insomnia ratings; weekly sleepiness/fatigue ratings; weekly mood ratings; weekly medical symptoms checklist
Expected Total Enrollment:  44

Ages Eligible for Study:  25 Years   -   55 Years,  Genders Eligible for Study:  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, bronchodillators, 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00156533

Jeffrey Swan, M.A.      585-273-2571    Jeffrey_Swan@urmc.rochester.edu
Heather Kennedy, B.A.      585-4Sleepy    Heather_Kennedy@urmc.rochester.edu

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

Study chairs or principal investigators

Michael L Perlis, Ph.D.,  Principal Investigator,  University of Rochester   

Study ID Numbers:  PI Initiated; 11045
Last Updated:  September 9, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00156533
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13