Conditions: Insomnia
Keywords: Pulmonary Disease, Chronic Obstructive
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
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 chronic obstructive pulmonary disease (COPD). This is a crossover study, so all participants will receive both suvorexant and placebo while on study. The primary hypothesis of this study is that multiple doses of suvorexant do not produce a clinically significant reduction of mean oxygen saturation (SaO2) during total sleep time in participants with COPD, as compared to placebo.

Detailed description:

Arms:
arm 1: During Period 1, participants \<65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening and participants ≥65 years of age were administered a 30-mg oral dose of

suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. arm 2: During Period 1, participants \<65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening and participants ≥65 years of age received one placebo tablet matching

suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.

Interventions: intervention 1: suvorexant intervention 2: Placebo
Intervention descriptions: intervention 1: one tablet (30 or 40 mg suvorexant depending on participant age: 40 mg for participants \<65 years of age and 30 mg for participants ≥65 years of age), orally, once daily, for 4 consecutive days intervention 2: one tablet matching suvorexant, orally, once daily, for 4 consecutive days

Protocol document: