Dayvigo is approved in Japan to treat insomnia. Eisai

Eisai Co., Ltd. announced that it has obtained the manufacturing and marketing approval in Japan for its in-house discovered orexin receptor antagonist Dayvigo (2.5mg, 5mg, and 10mg tablets, lemborexant) for treatment of insomnia. Dayvigo is a dual orexin receptor antagonist that inhibits orexin neurotransmission regulating sleep-wake rhythm by binding competitively to the two subtypes of orexin receptors (OX1R and OX2R). Blocking the binding of wake-promoting neuropeptides orexin to orexin receptors is thought to suppress wake drive by balancing sleep-wake circuitry. Dayvigo binds to orexin receptors OX1R and OX2R and acts as a competitive antagonist with stronger inhibition effect on OX2R. Higher affinity and faster on/off receptor kinetics of Dayvigo to OX2R, which also suppresses non-REM sleep, indicate its potential to facilitate the non-sedative onset and maintenance of sleep. This approval was mainly based on the results of two pivotal Phase III clinical studies in adult patients with insomnia, SUNRISE 2'1 and SUNRISE 1'2, enrolling approximately 2,000 patients. Approval was also based on important safety studies (Study 108 '3, Study 106' 4), which included assessment of residual next-morning effects via postural stability (falling prediction indicator), memory after middle-of-the-night awakening.