Conditions: Sleep Apnea
Keywords: Insomnia obstructive sleep apnea orexin receptor antagonist
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: no

Brief summary:
This study will evaluate the safety, tolerability, and effect of multiple doses of suvorexant (MK-4305) on respiratory function in participants with mild to moderate obstructive sleep apnea (OSA) compared to administration of placebo. The primary hypothesis of this study is that multiple doses of MK-4305 do not produce a clinically significant increase in Apnea-Hypopnea Index (AHI) in participants with mild to moderate OSA, as compared to placebo.

Detailed description:

Arms:
arm 1: In Period 1, suvorexant (40 mg tablets) administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening. arm 2: In Period 1, placebo administered orally once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered once daily for 4 consecutive days in the evening.

Interventions: intervention 1: Suvorexant intervention 2: Matching Placebo
Intervention descriptions: intervention 1: 40 mg tablets, orally once daily for 4 consecutive days in the evening intervention 2: Placebo tablets, orally once daily for 4 consecutive days in the evening

Protocol document: