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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

Tracking Information
First Submitted Date November 2, 2009
First Posted Date November 3, 2009
Last Update Posted Date November 7, 2011
Study Start Date December 2005
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2009)
Sleep recording measures [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01006525 on Archive Site
Current Secondary Outcome Measures
 (submitted: November 2, 2009)
Urine and saliva cortical levels [ Time Frame: one year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Safety and Efficacy of Chronic Hypnotic Use
Official Title Abuse Liability Associated With Chronic Hypnotic Use
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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
urine and saliva
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.
Condition Primary Insomnia
Intervention Drug: zolpidem
placebo or zolpidem (10mg)daily for one year
Other Name: zolpidem (Ambien)
Study Groups/Cohorts Insomniacs
Primary insomniacs, ages 21-70, in good general health.
Intervention: Drug: zolpidem
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 4, 2011)
Original Estimated Enrollment
 (submitted: November 2, 2009)
Actual Study Completion Date August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sexes Eligible for Study: All
Ages 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01006525
Other Study ID Numbers R01DA017355( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Timothy Roehrs, Ph.D., Henry Ford Health System
Study Sponsor Henry Ford Health System
Collaborators Not Provided
Principal Investigator: Timothy A. Roehrs, Ph.D. Henry Ford Health System
Study Director: Surilla Randall, Ph.D. Henry Ford Health System
PRS Account Henry Ford Health System
Verification Date November 2011