Posted by phidippus on March 13, 2015, at 12:22:07
In reply to Re: Horrible sleep problems » phidippus, posted by babbler20 on March 12, 2015, at 23:22:32
For instance, in one study, people on the sleeping pill at the three-month mark slept 60.3 minutes longer, on average, while those on placebo slept 40.6 minutes longer -- a difference of more than 19 minutes.
"Nineteen minutes a night of more sleep for an entire month is a lot of additional sleep," Krystal says.
In the same study, those on suvorexant fell asleep about 25 minutes faster than at the start of the study; those on placebo fell asleep about 17 minutes faster.
Those on the pill spent about 48 minutes less time awake during the night than before the medication, compared to 25 fewer minutes for those on the placebo. For the second study, results were similar. "The fact [that] there is benefit on the sleep study finding and the self reporting finding is critical," Krystal says.
"What we've seen here and confirmed in [the later studies] is that suvorexant helps people with insomnia fall asleep faster and wake less," says Herring, who led the published study. "It is effective over the long term and well tolerated."The published study tested whether a range of doses, each given in a sleep lab to about 60 people suffering from insomnia, improved sleep better than an inactive placebo pill. Without knowing which was which, each study participant took either suvorexant or the placebo for four weeks, then switched to the other for another four weeks.
The main study measure was sleep efficiency -- that is, the percentage of an eight-hour night people slept. At the beginning of the study, participants average sleep efficiency was 66%. After falling asleep, they woke for an average 101 minutes during the night.
"There was a range of results, but generally sleep efficiency improved 5% to 13% compared to placebo," Herring says. "We also found that patients have 21 to 37 minutes less time awake during the night."
Insomnia Slideshow: 20 Tips for Better Sleep
Every Bit HelpsThat may not seem like a lot. But it could mean a lot to a person suffering from insomnia, says Richard Simon Jr., MD, director of the Kathryn Severyns Dement Sleep Disorders Center in Walla Walla, Wash.
"Insomnia patients seem to feel better and function better when they get 15 to 20 minutes more sleep," Simon says. "This is an intriguing study that shows this drug does improve sleep. That is big."
Suvorexant in Patients with Insomnia: Results from Two 3-Month Randomized Controlled Clinical Trials
W. Joseph Herringcorrespondenceemail
,
Kathryn M. Connor
,
Neely Ivgy-May
,
Ellen Snyder
,
Ken Liu
,
Duane B. Snavely
,
Andrew D. Krystal
,
James K. Walsh
,
Ruth M. Benca
,
Russell Rosenberg
,
R. Bart Sangal
,
Kerry Budd
,
Jill Hutzelmann
,
Heather Leibensperger
,
Samar Froman
,
Christopher Lines
,
Thomas Roth
,
David Michelson
Received: May 8, 2014; Received in revised form: September 5, 2014; Accepted: October 1, 2014; Published Online: October 22, 2014
DOI: http://dx.doi.org/10.1016/j.biopsych.2014.10.003
Publication stage: In Press Corrected Proof
showArticle Info
Abstract
BackgroundSuvorexant is an orexin receptor antagonist for treatment of insomnia. We report results from two pivotal phase 3 trials.
MethodsTwo randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in nonelderly (1864 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.
ResultsSuvorexant 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.
Eric
ConclusionsSuvorexant improved sleep onset and maintenance over 3 months of nightly treatment and was generally safe and well tolerated.
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