Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of the study is to evaluate the long term efficacy of sodium oxybate
      (Xyrem®) and zolpidem tartrate (Ambien®) in treating chronic insomnia. We will compare the
      efficacy of sodium oxybate with zolpidem tartrate (Ambien®), and compare the efficacy of each
      of these two medications with placebos.
    

Detailed description: 
      Primary aim:

      1. To assess the long term efficacy of sodium oxybate and zolpidem tartrate in reducing
      insomnia and improving sleep quality as assessed by a range of self-reported measures.

      Questionnaires and Rating Scales: Subjects completed the following questionnaires and scales:
      Insomnia Severity Index, Epworth Sleepiness Scale (ESS), Beck Depression Inventory,
      Pittsburgh Sleep Quality Index (PSQI), Profile of Mood States-Fatigue (POMS). These
      questionnaires were administered at study baseline, treatment week 4, 8 and 12.

      Clinical Global Impression (CGI). The CGI is a clinician-rated scale composed of two
      subscales that measure disease severity and degree of change, respectively. CGI-Severity
      (CGI-S) is a single-item, global scale of disease severity that requires the investigator to
      compare the patient's symptoms with those of all other patients who have the disorder. It is
      scored from 1 (normal) to 6 (among the most extremely ill of patients). CGI-Change (CGI-C) is
      a single-item scale of symptomatic improvement or worsening that requires the investigator to
      compare the patient's status at the time of assessment with baseline severity (baseline
      CGI-S). One study investigator performed all CGI-S and CGI-C ratings for all subjects.

      Randomization. After completing all baseline procedures, eligible subjects were randomized to
      receive either a combination of active SXB and placebo ZOL (pZOL), active ZOL and placebo SXB
      (pSXB), or pSXB and pZOL, in a 1:1:1 parallel double-dummy design. A member of the study team
      who had no contact with subjects and no other role in this study was responsible for
      preparing study medications according to a randomization schedule. ZOL was encapsulated in
      lactose powder filled gelatin capsules to be indistinguishable from placebo capsules. Liquid
      pSXB was designed to match active SXB in appearance, taste and consistency. Subjects were
      given both liquid and capsule study medications, to maintain the double dummy design. Due to
      the flexible dose design of this study, subjects and investigators were not blinded to the
      dosages of study medication/placebo. All subjects were instructed to start study medication
      at 2.25 grams of SXB/pSXB and 5mg of ZOL/pZOL at bedtime. One study investigator reviewed all
      potential known side effects of SXB and ZOL prior to dosing, and subjects were instructed to
      take study medications at the bedside immediately before attempting to sleep, as is the
      standard administration for SXB.
    

Intervention name(s): zolpidem tartrate; sodium oxybate; Matching Placebos
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Ambien; Zolpidem; Xyrem; Placebo; Sugar pill
Intervention MeSH terms: Sodium Oxybate; Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment