Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing

NCT ID: NCT00156533

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-02-29

Brief Summary

We want to assess whether "how and when" one takes sleep medication results in similar or different outcomes with respect to symptom relief. We also want to know whether taking medication for a period of time provides continued benefit once the medication is stopped.

Detailed Description

To date, the aggressive treatment (Tx) of chronic insomnia has been evaluated in terms of whether maintenance therapy is possible. While what constitutes maintenance therapy is a matter of debate, there are two studies which show that benzodiazepine receptor agonists (BZRAs) 1) are effective when used intermittently for up to 3 months and 2) may be used on a nightly basis for up to 6 months with no loss of efficacy.

The significance of the present research is two fold. First, it will allow us to compare the two primary strategies used for long term treat of insomnia (nightly dosing vs intermittent dosing). Second, it will allow an evaluation of the possibility that extended treatment, given careful withdrawal from medication, may yield long term clinical gains.

Re: Objective 1: It is widely assumed that intermittent dosing confers increased efficacy. That is, less frequent medication use will extend the duration of time for which the medication is maximally potent. An empirical assessment of this proposition is required. If incorrect, physicians and patients should be encouraged to adopt a more aggressive approach to treatment. If correct, physicians and patients should be encouraged to adopt the intermittent dosing approach to treatment.

Re: Objective 2: It is widely assumed that treatment with sedatives (sleep promoting medications) constitutes only palliative care. An empirical assessment of this proposition is required. If correct, physicians and patients should be encouraged to adopt a more aggressive approach to long term treatment. If incorrect, physicians and patients should be encouraged to adopt an approach to treatment that is not currently a standard of practice: extended treatment with a clear plan to taper medication that is designed to maintain the clinical gains that occurred with medication use.

We propose to evaluate the above issues in a pilot study of 40 subjects with Primary Insomnia where subjects are randomized to one of 4 conditions:

1. QHS dosing with placebo

2. QHS dosing with 10mg of zolpidem

3. Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)

4. Monitor only condition.

Conditions

Insomnia; Primary Insomnia; Psychophysiologic Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

QHS dosing with placebo (i.e. nightly dose)

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DRUG

QHS Zolpidem

QHS dosing with 10mg of zolpidem (i.e. nightly dose)

Group Type: ACTIVE_COMPARATOR

Zolpidem

Intervention Type: DRUG

10 mg of Zolpidem

Intermittant Zolpidem

Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed

Group Type: EXPERIMENTAL

Zolpidem

Intervention Type: DRUG

10 mg of Zolpidem

Control

Monitor only condition (no placebo, no drug).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Zolpidem

10 mg of Zolpidem

Intervention Type: DRUG

Sugar Pill

Intervention Type: DRUG

Other Intervention Names

Ambien

Eligibility Criteria

Inclusion Criteria

• Ages 25 - 55
• a stable sleep/wake schedule with a preferred sleep phase between 10:00 p.m. and 8:00 a.m.
• Patients with Primary Insomnia will meet diagnostic criteria for Psychophysiologic Insomnia according to the International Classification of Sleep Disorders manual (ICSD).
• complaint of disturbed sleep must have the following characteristics: >30 minutes to fall asleep, and/or >30 minutes wake after sleep onset time, a total sleep time of no more than 6.5 hours (or a sleep efficiency of less than 85%), a problem frequency of >4 nights/ week and a problem duration >6 months.

Exclusion Criteria

• Unstable medical or psychiatric illness
• Use of medication that may cause insomnia or may be reduce the effectiveness of zolpidem (e.g. selective serotonin reuptake inhibitors(SSRI's), steroids, bronchodilators, calcium channel blockers, beta blockers, etc.)
• symptoms suggestive of sleep disorders other than insomnia
• polysomnographic data indicating sleep disorders other than insomnia
• Evidence of active illicit substance use or fitting criteria for alcohol abuse or dependence
• inadequate language comprehension
• pregnancy
• first-degree relatives with bipolar disorder or schizophrenia

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi-Synthelabo

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Wilfred Pigeon, PhD

Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael L Perlis, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Sleep Research Laboratory

Rochester, New York, United States

Countries

United States

Other Identifiers

11045

Identifier Type: OTHER

Identifier Source: secondary_id

PI Initiated

Identifier Type: -

Identifier Source: org_study_id