The Effects of Lemborexant on the Ability to Sleep During Daytime
NCT06231641 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-04-06
Summary
This study aim to evaluate whether a dose of 5 mg of lemborexant, as compared to a placebo, may improve daytime recovery sleep, without producing lingering sleepiness during wakefulness, using a 3-day simulated night shift protocol in the lab under constant monitoring.
Conditions
- Shift-Work Sleep Disorder
Interventions
- DRUG
-
Lemborexant 5 MG [Dayvigo]
Lemborexant 5 mg will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening.
- OTHER
-
Matching Placebo
Matching placebo will be taken orally once per day just prior to initiating laboratory-supervised daytime sleep episodes, for three consecutive days, within a few minutes before going to bed, with at least seven hours remaining before the planned time of awakening.
Sponsors & Collaborators
-
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 20 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-01-11
- Primary Completion
- 2026-03-31
- Completion
- 2026-03-31
- FDA Drug
- Yes
Countries
- Canada
Study Locations
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