Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Safety and Efficacy of Chronic Hypnotic Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01006525
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : November 7, 2011
Information provided by:
Henry Ford Health System

Brief 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.

Condition or disease Intervention/treatment
Primary Insomnia Drug: zolpidem

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 116 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abuse Liability Associated With Chronic Hypnotic Use
Study Start Date : December 2005
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Primary insomniacs, ages 21-70, in good general health.
Drug: zolpidem
placebo or zolpidem (10mg)daily for one year
Other Name: zolpidem (Ambien)

Primary Outcome Measures :
  1. Sleep recording measures [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Urine and saliva cortical levels [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
urine and saliva

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Primary insomniacs meeting DSM-IV criteria, ages 23-70 yrs. old, were recruited from public advisement for a double-blind placebo controlled study. Participants were in good general health as determined by a physical exam and laboratory tests. The Structured Clinical Interview for DSM Disorders (SCID) and the Hamilton Depression Scale were used to exclude those with psychiatric disorders, drug, and alcohol dependence. To confirm the absence of illicit drugs, participants underwent a urine drug screen. Additionally, participants had a screening sleep efficiency of <85% on an 8-hr nocturnal polysomnogram (NPSG) and had no primary sleep disorders. Pregnant or lactating females were excluded from study participation.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01006525

Layout table for location information
United States, Michigan
Henry Ford Sleep and Research Center
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Layout table for investigator information
Principal Investigator: Timothy A. Roehrs, Ph.D. Henry Ford Health System
Study Director: Surilla Randall, Ph.D. Henry Ford Health System

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Timothy Roehrs, Ph.D., Henry Ford Health System Identifier: NCT01006525    
Other Study ID Numbers: R01DA017355 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: November 7, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Sleep Aids, Pharmaceutical
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action