Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
|Insomnia Primary Insomnia Psychophysiologic Insomnia||Drug: Zolpidem Drug: Sugar Pill||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Sleep Latency (SL) [ Time Frame: Baseline and Post-treatment (12wks) ]Number of subjects with any reduction in SL (time to fall asleep in minutes)at post-tx compared to baseline where mean SL = mean of daily values for one week calculated from sleep diary values.
- Wake After Sleep Onset (WASO) [ Time Frame: Baseline and Post-Treatment (12 weeks) ]Number of subjects with any reduction in WASO at post-tx compared to baseline where mean WASO = mean of daily values for one week calculated from sleep diary values.
|Study Start Date:||March 2005|
|Study Completion Date:||February 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
QHS dosing with placebo (i.e. nightly dose)
|Drug: Sugar Pill|
Active Comparator: QHS Zolpidem
QHS dosing with 10mg of zolpidem (i.e. nightly dose)
10 mg of Zolpidem
Other Name: Ambien
Experimental: Intermittant Zolpidem
Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
10 mg of Zolpidem
Other Name: Ambien
No Intervention: Control
Monitor only condition (no placebo, no drug).
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:
- QHS dosing with placebo
- QHS dosing with 10mg of zolpidem
- Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
- Monitor only condition.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156533
|United States, New York|
|University of Rochester Sleep Research Laboratory|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Michael L Perlis, Ph.D.||University of Rochester|