Insomnia
Conditions
Interventions
Lemborexant
Sponsors
Fujita Health University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: It will include both female and male outpatients (aged 20 or more than 20 years) who attend the Department of Psychiatry in Fujita Health University Hospital and who experience any of the following insomnia symptoms for four or more nights during the week before they started the study: total sleep time (TST): 6 hours, time to sleep onset (TSO): 30 or more than 30 minutes, or two or more episodes of wake after sleep onset.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sleep onset, total sleep time, wake time after sleep onset | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjects' reported sleep satisfaction level, and the severity of their psychiatric disorder, discontinuation rate, incidence of individual adverse events | — |
Countries
Japan
Contacts
Public ContactTaro Kishi
Fujita Health University School of Medicine Psychiatry
Outcome results
None listed