drugset / Trial / NCT05463861

Lemborexant in Delayed Sleep Phase Syndrome

NCT05463861

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

EvaluationDrugModalityDoseRoute
Comparator Lemborexant Small molecule 5 mg Oral
Comparator Lemborexant Small molecule 10 mg Oral