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
Intervention: zolpidem tartrate; sodium oxybate; Matching Placebos
Intervention MeSH terms: Sodium Oxybate; Zolpidem
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent is obtained.

          2. The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age
             (inclusive).

          3. Patient reports insomnia for at least six months, and insomnia causes the patient
             distress.

          4. The Investigator determines that the patient meets diagnostic criteria for Chronic
             Insomnia according to International Classification of Sleep Disorders (ICSD) criteria.

          5. Sleep diary based screening shows sleep onset latency >30 minutes, and /or wake after
             sleep onset >30 minutes per night at least 3 nights per week, with combined
             wake-time-in-bed _> 45 minutes.

          6. The patient is in good health as determined by a medical and psychiatric history, and
             physical examination.

          7. Women must be surgically sterile, 2 years post-menopausal, or if of child-bearing
             potential, using a medically accepted method of birth control, and agree to continued
             use of this method for the duration of the study.

          8. The patient is willing and able to comply with study restrictions and to attend
             regularly scheduled clinic visits as specified in this protocol.

        Exclusion Criteria:

          1. Has any clinically significant, uncontrolled medical or psychiatric conditions.
             (treated or untreated)

          2. Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia.

          3. Used any prescription drugs disallowed by the protocol or clinically significant use
             of over-the counter(OTC) drugs within 14 days before the screening visit.

          4. Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V.

          5. Has a clinically significant deviation from normal in the physical examination.

          6. Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will
             be withdrawn from the study.)

          7. Has any disorder that may interfere with drug absorption, distribution, metabolism, or
             excretion (including gastrointestinal surgery and succinic semialdehyde dehydrogenase
             deficiency)

          8. Has a known clinically significant drug sensitivity to sodium oxybate or sedative
             hypnotics.