drugset / Trial / NCT05463861
Lemborexant in Delayed Sleep Phase Syndrome
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to evaluate whether Lemborexant is more effective than placebo in shortening sleep onset latency in patients with delayed sleep phase syndrome (both type 1 and type 2). This will be tracked using sleep logs as well as actigraphy. In this 2-year study, we will examine if Lemborexant administered 5-10 mg nightly taken at desired bedtime (at least 2 hours prior to self-reported sleep onset habitual time) can improve the symptoms of Delayed Sleep Phase Syndrome.
Timeline
- Start
- 2022-02-01
- Primary completion
- 2026-01-21
- Completion
- 2026-01-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lemborexant | Small molecule | 5 mg | Oral |
| Comparator | Lemborexant | Small molecule | 10 mg | Oral |