emborexant for insomnia in patients with psychiatric disorder: A 1-week, open-label study
Phase 4
Recruiting
- Conditions
- Insomnia
- Registration Number
- JPRN-UMIN000041321
- Lead Sponsor
- Fujita Health University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
The following exclusion criteria will be applied: taking any sleeping pills other than ramelteon, zolpidem, zopiclone, or eszopiclone at baseline; contraindication to suvorexant; patients with coma; addiction to psychostimulants or alcohol; pregnancy or breastfeeding; neurological or systemic diseases; and anyone considered inappropriate to participate by the attending physician. We will not include any patient who received benzodiazepines before the study because sleeping pills other than the Z drugs (zolpidem, zopiclone, or eszopiclone) or ramelteon.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to sleep onset, total sleep time, wake time after sleep onset
- Secondary Outcome Measures
Name Time Method Subjects' reported sleep satisfaction level, and the severity of their psychiatric disorder, discontinuation rate, incidence of individual adverse events