Safety and Efficacy of Chronic Hypnotic Use

This study has been completed.
Sponsor:
Information provided by:
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01006525
First received: November 2, 2009
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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 Intervention
Primary Insomnia
Drug: zolpidem

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abuse Liability Associated With Chronic Hypnotic Use

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

Primary Outcome Measures:
  • Sleep recording measures [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urine and saliva cortical levels [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

urine and saliva


Enrollment: 116
Study Start Date: December 2005
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Insomniacs
Primary insomniacs, ages 21-70, in good general health.
Drug: zolpidem
placebo or zolpidem (10mg)daily for one year
Other Name: zolpidem (Ambien)

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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006525

Locations
United States, Michigan
Henry Ford Sleep and Research Center
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Timothy A. Roehrs, Ph.D. Henry Ford Health System
Study Director: Surilla Randall, Ph.D. Henry Ford Health System
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timothy Roehrs, Ph.D., Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01006525     History of Changes
Other Study ID Numbers: R01-DA17355
Study First Received: November 2, 2009
Last Updated: November 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Zolpidem
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014