Merck has received approval from the U.S. Food and Drug Administration (FDA) for an update to the prescribing information for BELSOMRA (suvorexant) C-IV to include findings on its use for the treatment of insomnia in patients with mild-to-moderate Alzheimer’s disease. BELSOMRA is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
“Alzheimer’s disease is often accompanied by disruptions to an individual’s sleep-wake patterns and overall difficulty sleeping,” says W. Joseph Herring, MD, PhD, associate vice president, Global Clinical Research, Neuroscience, Merck Research Laboratories, in a release. “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.”
This update includes findings of a randomized, double-blind, placebo-controlled, parallel-group, multi-site 4-week polysomnography trial of BELSOMRA in patients with mild-to-moderate Alzheimer’s disease, which were recently published online in Alzheimer’s & Dementia: Journal of the Alzheimer’s Association. In this study, BELSOMRA exhibited a statistically significant improvement for both total sleep time (TST) and wake after sleep onset (WASO) measures, compared to those treated with placebo, as assessed objectively by polysomnography.
Adverse reactions occurring ≥2% and greater than placebo were somnolence (4% compared to 1% for placebo), dry mouth (2% compared to 1% for placebo), and falls (2% compared to 0% for placebo). Results were originally presented at the 2019 American Academy of Neurology Annual Meeting.