A label update for the insomnia drug Belsomra (suvorexant) C-IV adds study findings on its use in treating insomnia in patients with mild-to-moderate Alzheimer’s disease, drugmaker Merck announced after the US Food and Drug Administration granted approval for the addition.
The phase 3, double-blind trial included 285 people with Alzheimer’s disease and insomnia. Over 4 weeks, 142 participants received suvorexant, and 143 received placebo.
Patients receiving suvorexant showed a statistically significant improvement in measures of total sleep time and wake after sleep onset, as assessed by polysomnography, compared with patients who received placebo, Merck reported. Researchers presented results at the 2019 American Academy of Neurology Annual Meeting and later published them in Alzheimer’s & Dementia: The Journal of the Alzheimer's Association.
“We’re pleased that the prescribing information for Belsomra now includes findings from Merck’s first dedicated study of an insomnia medication in patients with mild-to-moderate Alzheimer’s disease,” said W. Joseph Herring, MD, PhD, associate vice president of global clinical research and neuroscience at Merck Research Laboratories.
Belsomra is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
Merck receives approval for BELSOMRA (suvorexant) C-IV label update to include findings from study of insomnia in patients with mild-to-moderate Alzheimer’s disease [press release]. Kenilworth, New Jersey: Merck; February 3, 2020.