Safety and Efficacy of Chronic Hypnotic Use

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine how safe and effective it is for people with insomnia to use zolpidem on a nightly basis for one year.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry Ford Health System
• Treatments: Hypnotics and Sedatives; Zolpidem

Criteria

Inclusion Criteria:

1. age 21-70 yrs

2. non-pregnant females who agree to standard birth control for 12 months and males

3. two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep.

4. meet DSM-IV criteria for primary insomnia

Exclusion Criteria:

1. any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem.

2. chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses.

3. current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia.

4. a history of alcohol or substance abuse within the past two years.

5. a prestudy positive urine drug screen

6. consuming >14 standard (1oz) alcoholic drinks per week

7. caffeine consumption >300 mg/day

8. smoking during the night (11pm-7am).

9. medications including: anxiolytics, hypnotics. both prescription and OTC, (except in the chronic zolpidem group), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H1 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented.

10. sleep disordered breathing (SDB) defined as >10 apnea-hypopneas events per hour of sleep time or any other primary sleep (e.g., restless legs syndrome) or circadian disorder.