New Rx treatment option for adults with insomnia debuts in USA

Dayvigo (lemborexant), developed in-house by Japanese drug major Eisai (TYO: 4523) for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, is now available for patients in the USA, making it the first new insomnia prescription drug to be launched in the USA for five years. Insomnia is a prevalent issue, with up to 30% of adults worldwide reporting insomnia symptoms.

The US Food and Drug Administration approval of Dayvigo in December 2019 was based on findings from the robust lemborexant clinical development program that included two pivotal Phase III studies in around 2,000 adult patients with insomnia. Dayvigo is the first FDA-approved insomnia medication with safety data over a 12-month treatment period and with sleep onset and sleep maintenance efficacy data over a six-month treatment period in a pivotal clinical study.

Dayvigo was approved in Japan in January this year.