Long Term Treatment With Zolpidem: Nightly and Intermittent Dosing
Condition: Insomnia; Primary Insomnia; Psychophysiologic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Zolpidem; Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg of Zolpidem
Other intervention name(s): Ambien
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Sleep; zolpidem; Ambien; Hypnotics