Safety and Efficacy of Chronic Hypnotic Use

Primary Insomnia Clinical Trial

Official title:

Abuse Liability Associated With Chronic Hypnotic Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01006525
• Other study ID #: R01DA017355
• Status: Completed
• Phase: N/A
• First received: November 2, 2009
• Last updated: November 4, 2011
• Start date: December 2005
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Primary Insomnia

Intervention

Drug:
• zolpidem
placebo or zolpidem (10mg)daily for one year

Locations

Country	Name	City	State
United States	Henry Ford Sleep and Research Center	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep recording measures		one year	No
Secondary	Urine and saliva cortical levels		one year	No