FDA Approves Expanded Indication for Suvorexant to Treat Insomnia in Alzheimer Disease 

The Food and Drug Administration (FDA) approved an update to the prescribing information for suvorexant (BELSOMRA C-IV; Merck, Kenilworth, NJ) to include treating insomnia in individuals with mild-to-moderate Alzheimer disease (AD). 

Insomnia is more common in people with AD than those who don’t have the disease. The update includes findings from a phase 3 randomized, placebo-controlled polysomnography trial (NCT02750306) of suvorexant that were published online in Alzheimer’s & Dementia: The Journal of the Alzheimer's Association. In the study, suvorexant showed a statistically significant improvement for both total sleep time (TST) and wake after sleep onset (WASO) compared with those treated with placebo, as assessed by polysomnography.

Suvorexant is a first-in-class oral orexin receptor antagonist. The mechanism by which suvorexant works is presumed to be through antagonism of orexin receptors.

The trial was conducted in 285 participants, male and female, age 50 to 90 , who were treated with suvorexant (n=142) or placebo (n=143). Participants treated with suvorexant received 10 mg for 14 days and 77% of those participants were increased to 20 mg for 14 additional days.

“AD is often accompanied by disruptions to an individual’s sleep-wake patterns and overall difficulty sleeping,” said W. Joseph Herring, MD, PhD, 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 AD.”