Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
116 participants
OBSERVATIONAL
2005-12-31
2011-08-31
Brief Summary
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Detailed Description
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This project, using both prospective and retrospective methods, will address questions about the long-term abuse liability and efficacy of the BzRAs. The questions being raised are: What are the abuse liability and efficacy of hypnotics currently being used chronically and what is the prospective abuse liability and efficacy of hypnotics used chronically? Zolpidem is the chosen standard for this project as it is the most frequently prescribed BzRA and also arguably the BzRA with the best short-term efficacy and safety profile. The focus of the first question is clinical; it is about the long-term abuse liability and efficacy of BzRAs, specifically zolpidem, as it is currently being prescribed and about the type of patients who receive this drug. The second question addresses the issue of whether a standard BzRA can be prescribed efficaciously and safely for the long-term to patients with primary insomnia.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Insomniacs
Primary insomniacs, ages 21-70, in good general health.
zolpidem
placebo or zolpidem (10mg)daily for one year
Interventions
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zolpidem
placebo or zolpidem (10mg)daily for one year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
21 Years
70 Years
ALL
Yes
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Henry Ford Health System
Principal Investigators
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Timothy A. Roehrs, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Surilla Randall, Ph.D.
Role: STUDY_DIRECTOR
Henry Ford Health System
Locations
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Henry Ford Sleep and Research Center
Detroit, Michigan, United States
Countries
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References
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Roehrs TA, Randall S, Harris E, Maan R, Roth T. Twelve months of nightly zolpidem does not lead to rebound insomnia or withdrawal symptoms: a prospective placebo-controlled study. J Psychopharmacol. 2012 Aug;26(8):1088-95. doi: 10.1177/0269881111424455. Epub 2011 Oct 16.
Roehrs TA, Randall S, Harris E, Maan R, Roth T. Twelve months of nightly zolpidem does not lead to dose escalation: a prospective placebo-controlled study. Sleep. 2011 Feb 1;34(2):207-12. doi: 10.1093/sleep/34.2.207.
Roehrs T, Roth T. Hyperarousal in insomnia: pre-sleep and diurnal cortisol levels in response to chronic zolpidem treatment. Sleep Med. 2019 Sep;61:52-56. doi: 10.1016/j.sleep.2019.04.010. Epub 2019 Apr 25.
Roehrs TA, Roth T. Hyperarousal in insomnia and hypnotic dose escalation. Sleep Med. 2016 Jul;23:16-20. doi: 10.1016/j.sleep.2016.06.008. Epub 2016 Jul 6.
Roehrs TA, Roth T. Gender Differences in the Efficacy and Safety of Chronic Nightly Zolpidem. J Clin Sleep Med. 2016 Mar;12(3):319-25. doi: 10.5664/jcsm.5574.
Randall S, Roehrs TA, Roth T. Efficacy of eight months of nightly zolpidem: a prospective placebo-controlled study. Sleep. 2012 Nov 1;35(11):1551-7. doi: 10.5665/sleep.2208.
Other Identifiers
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