Suvorexant (BELSOMRA) was an effective and well-tolerated treatment of insomnia, according to a new study presented at SLEEP 2015 in Seattle, Washington.
Merck launched suvorexant for the treatment of insomnia in adults who have difficulty falling asleep and/or staying asleep earlier this year. In the study, Merck researchers found that suvorexant was generally well-tolerated in both women and men. The most frequent adverse event was somnolence for both the 40/30 mg doses and the 20/15 mg doses.
“This research provides further insight into the efficacy and safety of [suvorexant],” said Joe Herring, MD, PhD, executive director of Clinical Neuroscience at Merck and main author of the study. “The results presented are relevant to prescribers in further supporting the evidence that no suvorexant dose adjustment is necessary based on intrinsic factors, including gender, age, or BMI.”
Suvorexant has a different mechanism of action from currently approved sleep medicines, according to Dr Herring. “We believe [suvorexant] will be an important alternative to therapies currently on the market.”
The researchers conducted efficacy analyses from 2 similar randomized, double-blind, placebo-controlled, parallel-group, three-month trials in elderly (≥ 65 years) and non-elderly (18 to 64 years) insomnia patients. Meanwhile, the gender subgroup analyses mirrored the improvements seen for suvorexant 40/30 mg and 20/15 mg over placebo on patient-reported outcomes and objective polysomnography endpoints. Similar efficacy was observed across genders.