Merck has announced that the company 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,” said Dr. W. Joseph Herring, associate vice president, Global Clinical Research, Neuroscience, Merck Research Laboratories. “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.