Conditions: Insomnia Disorder
Keywords: Insomnia Disorder E2006 Multiple Sleep Latency Test Lemborexant
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 69
Healthy volunteers: no

Brief summary:
This is a single-dose, randomized, placebo-controlled, 3-way crossover study of 2 dosage strengths of lemborexant (5 mg and 10 mg) in participants with insomnia disorder.

Detailed description:
The study will have 2 phases: Prerandomization and Randomization. The Prerandomization Phase will consist of 2 periods that taken together, will last up to a maximum of 21 days: a Screening Period and a Baseline Period. The Randomization Phase will comprise 4 treatment periods (Treatment 1, Treatment 2, Treatment 3, Treatment 4) with intervening washout periods between treatment periods (Washout 1, Washout 2, Washout 3). A single dose of study drug will be administered in a randomized, 3-way double-blind crossover manner at Treatment Periods 1-3; flurazepam 30 mg will be administered in an open-label manner at Treatment Period 4.

Arms:
arm 1: Participants will receive a single, oral tablet formulation dose of lemborexant 5 mg within 5 minutes before bedtime. arm 2: Participants will receive a single, oral tablet formulation dose of lemborexant 10 mg within 5 minutes before bedtime. arm 3: Participants will receive a single, oral tablet formulation dose of lemborexant-matched placebo within 5 minutes before bedtime. arm 4: Participants will receive a single, oral capsule formulation dose of flurazepam 30 mg within 5 minutes before bedtime.

Interventions: intervention 1: Lemborexant 5 mg intervention 2: Lemborexant 10 mg intervention 3: Lemborexant-matched placebo. intervention 4: Flurazepam 30 mg
Intervention descriptions: intervention 1: Lemborexant 5 mg tablet. intervention 2: Lemborexant 10 mg tablet. intervention 3: Lemborexant-matched placebo tablet. intervention 4: Flurazepam 30 mg capsule.

Protocol document: