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Sleep Initiation and Maintenance Disorders: HELP
Articles by Heather Leibensperger
Based on 1 article published since 2009
(Why 1 article?)
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Between 2009 and 2019, Heather Leibensperger wrote the following article about Sleep Initiation and Maintenance Disorders.
 
+ Citations + Abstracts
1 Clinical Trial Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. 2016

Herring, W Joseph / Connor, Kathryn M / Ivgy-May, Neely / Snyder, Ellen / Liu, Ken / Snavely, Duane B / Krystal, Andrew D / Walsh, James K / Benca, Ruth M / Rosenberg, Russell / Sangal, R Bart / Budd, Kerry / Hutzelmann, Jill / Leibensperger, Heather / Froman, Samar / Lines, Christopher / Roth, Thomas / Michelson, David. ·Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey. Electronic address: william_herring@merck.com. · Merck Sharp & Dohme Corporation, Whitehouse Station, New Jersey. · Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina. · Sleep Medicine and Research Center, St. Luke's Hospital, St. Louis, Missouri. · University of Wisconsin, Madison, Wisconsin. · Atlanta Sleep Medicine Clinic, Atlanta, Georgia. · Sleep Disorders Institute & Attention Disorders Institute, Oakland University William Beaumont School of Medicine, Sterling Heights. · Henry Ford Hospital Sleep Center, Detroit, Michigan. ·Biol Psychiatry · Pubmed #25526970.

ABSTRACT: 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.