On 3 February, Merck, a leading global biopharmaceutical company known as MSD outside of the US and Canada, announced that the US Food and Drug Administration (FDA) has approved an expanded indication for suvorexant for the treatment of insomnia in people with mild to moderate Alzheimer's disease (AD) dementia. Suvorexant was previously approved in the US for the treatment of insomnia characterised by difficulties with sleep onset and sleep maintenance.
This update includes findings of a randomised, double-blind and placebo-controlled Phase III trial evaluating suvorexant for insomnia in people with mild to moderate AD dementia. 285 participants (average age 70) from 8 countries (Canada, Finland, Italy, New Zealand, Peru, South Korea, UK, US) were included in the Phase III trial from May 2016 to September 2018 and received either 10 mg of suvorexant or placebo. Among the 142 patients who received suvorexant, 77% were increased to 20 mg.
Data have recently been published in the journal Alzheimer’s & Dementia. Findings showed that suvorexant was safe and increased total sleep time (28 minutes) in people with mild to moderate AD. An improvement in wake after persistent sleep onset (WASO) was also observed in the suvorexant group compared with placebo (16 minutes improvement for the drug). Furthermore, the investigators reported that somnolence was the most common adverse event but was of mild‐to‐moderate severity and did not result in discontinuation of the trial. Detailed results can be found in the publication:
https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12035
