A cross-over, polysomnography study to test the safety, tolerability and effectiveness of different doses of suvorexant (MK-4305) in the treatment of patients with primary insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
254
oral tablet taken before bedtime
Dose-matched placebo to suvorexant taken before bedtime (oral tablet)
LS Mean Sleep Efficiency (SE) During Periods 1 and 2
SE was defined as total sleep time (TST) in minutes divided by time in bed (measured from lights off to lights on; fixed at 8 hours on each Polysomnography \[PSG\] night) in minutes, multiplied by 100, where TST is defined as the total time (minutes) in Stages 1, 2, 3, 4 and Rapid Eye Movement (REM). SE= (total sleep time/time in bed) x 100
Time frame: Night 1 and end of Week 4
LS Mean Wake After Persistent Sleep Onset (WASO) During Periods 1 and 2
WASO was defined as the duration of wakefulness measured in minutes (any epoch of Stage 0) from persistent sleep onset (first epoch of the first twenty consecutive epochs of non-wake) to lights on.
Time frame: Night 1 and end of Week 4
LS Mean Latency to the Onset of Persistent Sleep (LPS) During Periods 1 and 2
LPS is defined as the duration of time measured in minutes from lights off to persistent sleep onset.
Time frame: Night 1 and end of Week 4
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