Lemborexant: First Approval
Compliance with Ethical Standards
Funding The preparation of this review was not supported by any external funding.Conflict of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Lesley Scott is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
Lemborexant (DAYVIGO™) is an orally administered, small molecule, competitive orexin receptor subtypes 1 and 2 antagonist is being developed by Eisai Inc. for the treatment of adult patients with insomnia and for adults with irregular sleep-wake rhythm disorder (ISWRD) associated with mild to moderate Alzheimer’s disease. In December 2019, lemborexant received its first global approval in the USA for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or maintenance. This article summarizes the milestones in the development of lemborexant leading to its first global approval for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or maintenance.
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