Clinical trial NCT00156533: Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Insomnia
Primary Insomnia
Psychophysiologic Insomnia
Keywords: Insomnia
Sleep
zolpidem
Ambien
Hypnotics
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Sanofi-Synthelabo
First posted: 2005-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Sleep Latency (SL)
timeFrame: Baseline and Post-treatment (12wks)
Secondary outcomes:
measure: Wake After Sleep Onset (WASO)
timeFrame: Baseline and Post-Treatment (12 weeks)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Sleep Research Laboratory
state: New York
Study officials:
affiliation: University of Rochester
name: Michael L Perlis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: