TY - JOUR
T1 - Suvorexant in Patients with Insomnia
T2 - Results from Two 3-Month Randomized Controlled Clinical Trials
AU - Herring, W. Joseph
AU - Connor, Kathryn M.
AU - Ivgy-May, Neely
AU - Snyder, Ellen
AU - Liu, Ken
AU - Snavely, Duane B.
AU - Krystal, Andrew D.
AU - Walsh, James K.
AU - Benca, Ruth M.
AU - Rosenberg, Russell
AU - Sangal, R. Bart
AU - Budd, Kerry
AU - Hutzelmann, Jill
AU - Leibensperger, Heather
AU - Froman, Samar
AU - Lines, Christopher
AU - Roth, Thomas
AU - Michelson, David
PY - 2016/1/15
Y1 - 2016/1/15
N2 - Background Suvorexant is an orexin receptor antagonist for treatment of insomnia. We report results from two pivotal phase 3 trials. Methods Two randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in nonelderly (18-64 years) and elderly (≥65 years) patients with insomnia. Suvorexant doses of 40/30 mg (nonelderly/elderly) and 20/15 mg (nonelderly/elderly) were evaluated. The primary focus was 40/30 mg, with fewer patients randomized to 20/15 mg. There was an optional 3-month double-blind extension in trial 1. Each trial included a 1-week, randomized, double-blind run-out after double-blind treatment to assess withdrawal/rebound. Efficacy was assessed at week 1, month 1, and month 3 by patient-reported subjective total sleep time and time to sleep onset and in a subset of patients at night 1, month 1, and month 3 by polysomnography end points of wakefulness after persistent sleep onset and latency to onset of persistent sleep (LPS). One thousand twenty-one patients were randomized in trial 1 and 1019 patients in trial 2. Results Suvorexant 40/30 mg was superior to placebo on all subjective and polysomnography end points at night 1/week 1, month 1, and month 3 in both trials, except for LPS at month 3 in trial 2. Suvorexant 20/15 mg was superior to placebo on subjective total sleep time and wakefulness after persistent sleep onset at night 1/week 1, month 1, and month 3 in both trials and at most individual time points for subjective time to sleep onset and LPS in each trial. Both doses of suvorexant were generally well tolerated, with <5% of patients discontinuing due to adverse events over 3 months. The results did not suggest the emergence of marked rebound or withdrawal signs or symptoms when suvorexant was discontinued. Conclusions Suvorexant improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.
AB - Background Suvorexant is an orexin receptor antagonist for treatment of insomnia. We report results from two pivotal phase 3 trials. Methods Two randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in nonelderly (18-64 years) and elderly (≥65 years) patients with insomnia. Suvorexant doses of 40/30 mg (nonelderly/elderly) and 20/15 mg (nonelderly/elderly) were evaluated. The primary focus was 40/30 mg, with fewer patients randomized to 20/15 mg. There was an optional 3-month double-blind extension in trial 1. Each trial included a 1-week, randomized, double-blind run-out after double-blind treatment to assess withdrawal/rebound. Efficacy was assessed at week 1, month 1, and month 3 by patient-reported subjective total sleep time and time to sleep onset and in a subset of patients at night 1, month 1, and month 3 by polysomnography end points of wakefulness after persistent sleep onset and latency to onset of persistent sleep (LPS). One thousand twenty-one patients were randomized in trial 1 and 1019 patients in trial 2. Results Suvorexant 40/30 mg was superior to placebo on all subjective and polysomnography end points at night 1/week 1, month 1, and month 3 in both trials, except for LPS at month 3 in trial 2. Suvorexant 20/15 mg was superior to placebo on subjective total sleep time and wakefulness after persistent sleep onset at night 1/week 1, month 1, and month 3 in both trials and at most individual time points for subjective time to sleep onset and LPS in each trial. Both doses of suvorexant were generally well tolerated, with <5% of patients discontinuing due to adverse events over 3 months. The results did not suggest the emergence of marked rebound or withdrawal signs or symptoms when suvorexant was discontinued. Conclusions Suvorexant improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.
KW - Insomnia
KW - Orexin
KW - Pharmacotherapy
KW - Randomized controlled trial
KW - Sleep
KW - Suvorexant
UR - http://www.scopus.com/inward/record.url?scp=84951568583&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84951568583&partnerID=8YFLogxK
U2 - 10.1016/j.biopsych.2014.10.003
DO - 10.1016/j.biopsych.2014.10.003
M3 - Article
C2 - 25526970
AN - SCOPUS:84951568583
SN - 0006-3223
VL - 79
SP - 136
EP - 148
JO - Biological Psychiatry
JF - Biological Psychiatry
IS - 2
ER -