Posted by Michael Wonder on 05 Feb 2020
Merck receives approval for Belsomra (suvorexant) C-IV label update to include findings from study of insomnia in patients with mild-to-moderate Alzheimer’s disease
3 February 2020 - Merck today announced that the company has received approval from the U.S. 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 characterised by difficulties with sleep onset and/or sleep maintenance.
This update includes findings of a randomised, 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.
