- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01006525
Safety and Efficacy of Chronic Hypnotic Use
Abuse Liability Associated With Chronic Hypnotic Use
Study Overview
Detailed Description
The acknowledged drugs of choice for the pharmacological treatment of insomnia are the benzodiazepine receptor agonist hypnotics (BzRA). Studies show that at therapeutic doses, used over the short-term, the abuse liability of BzRAs is relatively low and their efficacy outweighs their minimal risks. However, an increasing number of patients use BzRAs nightly for longer periods of time than is currently indicated (i.e. 4 weeks) and, minimal data on the long-term abuse liability and efficacy of these drugs exist.
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Sleep and Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 21-70 yrs
- non-pregnant females who agree to standard birth control for 12 months and males
- two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep.
- meet DSM-IV criteria for primary insomnia
Exclusion Criteria:
- 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.
- chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses.
- current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia.
- a history of alcohol or substance abuse within the past two years.
- a prestudy positive urine drug screen
- consuming >14 standard (1oz) alcoholic drinks per week
- caffeine consumption >300 mg/day
- smoking during the night (11pm-7am).
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Insomniacs
Primary insomniacs, ages 21-70, in good general health.
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placebo or zolpidem (10mg)daily for one year
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Sleep recording measures
Time Frame: one year
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one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Urine and saliva cortical levels
Time Frame: one year
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one year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Timothy A. Roehrs, Ph.D., Henry Ford Health System
- Study Director: Surilla Randall, Ph.D., Henry Ford Health System
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Agents
- Sleep Aids, Pharmaceutical
- GABA-A Receptor Agonists
- GABA Agonists
- Zolpidem
Other Study ID Numbers
- R01DA017355 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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