Phase 2
Completed N=48
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.
Sleep Initiation and Maintenance Disorders
Source: ClinicalTrials.gov NCT00383643 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Assessment of Clinical Global Impression-change. — 3.0; 4.2; 2.7 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Clinical Global Impression-change. |
3.0; 4.2; 2.7 | — |
| PRIMARY Assessment of Insomnia Severity Index |
10.5; 10.8; 8.4 | — |
| PRIMARY Assessment of Pittsburgh Sleep Quality Index (PSQI) |
8.3; 10.2; 7.9 | — |
| PRIMARY Assessment of Fatigue |
9.7; 8.0; 5.1 | — |
| PRIMARY Assessment of Sleepiness |
5.7; 2.9; 4.4 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent is obtained.
- The patient is an outpatient, man or woman of any ethnic origin, 18-75 years of age (inclusive).
- Patient reports insomnia for at least six months, and insomnia causes the patient distress.
- The Investigator determines that the patient meets diagnostic criteria for Chronic Insomnia according to International Classification of Sleep Disorders (ICSD) criteria.
- 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.
- The patient is in good health as determined by a medical and psychiatric history, and physical examination.
- 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.
- 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
- Has any clinically significant, uncontrolled medical or psychiatric conditions. (treated or untreated)
- Has a probable diagnosis of a current sleep disorder other than Chronic Insomnia.
- 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.
- Has a history of alcohol, narcotic, or any other abuse as defined by the DSM-V.
- Has a clinically significant deviation from normal in the physical examination.
- Is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
- Has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery and succinic semialdehyde dehydrogenase deficiency)
- Has a known clinically significant drug sensitivity to sodium oxybate or sedative hypnotics.
Data sourced from ClinicalTrials.gov (NCT00383643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.