Policy & Regulation
Eisai launches new insomnia drug Dayvigo (Lemborexant) CIV in US
3 June 2020 -

Japan-based pharmaceutical company, Eisai Co Ltd, announced on Tuesday that its US subsidiary Eisai Inc has launched its in-house discovered orexin receptor antagonist DAYVIGO (lemborexant) CIV for the treatment of adults with insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in the US on 1 June 2020.

Discovered at Eisai's Tsukuba Research Laboratories and developed in-house, DAYVIGO is a small-molecule compound. DAYVIGO was approved in the US by the US Food and Drug Administration (FDA) based on findings from the lemborexant clinical development program, which included two pivotal Phase 3 studies2 (SUNRISE 1 and SUNRISE 2) in nearly 2,000 adult patients with insomnia.

Analyses in both studies suggested DAYVIGO was not associated with rebound insomnia, and there was no evidence of withdrawal effects following treatment discontinuation, suggesting it does not produce physical dependence in those taking it for up to one year. 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.

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