A Long Term Safety Study of Suvorexant in Participants With Primary Insomnia (MK-4305-009 AM3)
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
Summary
This study will establish the safety and tolerability of suvorexant (MK-4305) when
administered for up to 14 months. Participants will be randomized to receive suvorexant or
placebo for a 12-month double-blind (DB) Treatment Phase. Participants who complete the
12-month DB Treatment Phase will enter a 2-month DB Randomized Discontinuation Phase. At the
time of initial randomization, participants assigned to receive suvorexant during the initial
12-month Treatment Phase will be simultaneously randomized, in a 1:1 ratio, to receive either
suvorexant or placebo during the 2-month Randomized Discontinuation Phase. Participants
randomized to receive placebo in the initial 12-month Treatment Phase will continue to
receive placebo during the 2-month Randomized Discontinuation Phase.
The first 3 nights of the Randomized Discontinuation Phase are referred to as the Run-Out
Phase, and will assess rebound and withdrawal.