Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial -

Safety and efficacy of suvorexant during 1-year treatment of insomnia with subsequent abrupt treatment discontinuation: a phase 3 randomised, double-blind, placebo-controlled trial
Information type: Randomised controlled trials
Source: The Lancet Neurology
Specialities: Mental health and illness | Neurological disorders
Summary
This RCT in pts with insomnia reported that over 1 year, 362 (69%) on suvorexant (30/40mg ON), an orexin receptor antagonist, experienced any ADR vs. 164 (64%) on placebo. At month 1, suvorexant improved total sleep time (38•7 vs.16 min) and time to sleep onset (—18 vs.−8•4 min).
UKMi comment
In July 2013, an advisory panel to the FDA noted that 10mg suvorexant should be the starting dose for most patients, and 15mg and 20mg could also be appropriate. However the safety data did not support the approval of the 30mg and 40mg dose.
Related links: Comment PharmaTimes report