FDA Approves Expanded Indication For Suvorexant To Treat Insomnia In Alzheimer Disease

Merck Research Laboratories announced that the U.S. Food and Drug Administration (FDA) approved an update to the prescribing information for suvorexant to include treating insomnia in individuals with mild-to-moderate Alzheimer disease (AD). The update includes findings from a phase 3 randomized, placebo-controlled polysomnography trial 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 and wake after sleep onset compared with those treated with placebo, as assessed by polysomnography. Suvorexant is a first-in . . .