Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing

Insomnia Clinical Trial

Official title: Long Term Treatment With Zolpidem: The Relative Efficacy of Nightly (Quaque Hora Somni [QHS]) & Intermittent Dosing and the Potential for Long Term Clinical Gains After Treatment Discontinuation.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insomnia
• Primary Insomnia
• Psychophysiologic Insomnia
• Sleep Initiation and Maintenance Disorders

• NCT number: NCT00156533
• Study type: Interventional
• Source: University of Rochester
• Status: Completed
• Phase: Phase 4
• Start date: March 2005
• Completion date: February 2008