Belsomra Labeling Updated to Include Data on Insomnia in Alzheimer Disease

The Food and Drug Administration (FDA) has approved updates to the prescribing information for Belsomra® (suvorexant; Merck) to include study findings for the treatment of insomnia in patients with mild to moderate Alzheimer disease.

The Clinical Studies section has been updated to include data from the phase 3, double-blind, placebo-controlled, 4-week polysomnography trial of Belsomra in 285 patients with mild to moderate Alzheimer disease for the treatment of insomnia. Patients were randomized to receive either placebo or Belsomra 10mg for 14 days (77% were increased to 20mg for an additional 14 days).

Results from the trial showed that patients treated with Belsomra demonstrated a statistically significant improvement for both total sleep time and wake after sleep onset measures, compared with those who received placebo, as assessed by polysomnography at week 4. Regarding safety, adverse reactions that occurred ≥2% and greater than placebo included somnolence, dry mouth, and falls.

“Alzheimer 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 disease.”

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Belsomra is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. The product is available as 5mg, 10mg, 15mg, and 20mg strength tablets and is a Schedule IV controlled substance.

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