(Headquarters: Tokyo; CEO: Haruo Naito) announced that its in-house developed dual orexin receptor antagonist, DAYVIGO® (brand name in China: 达卫可®, generic name: lemborexant), has been approved in China for the treatment of adult patients with insomnia. This condition is characterized by difficulties in initiating or maintaining sleep. Eisai plans to launch DAYVIGO in China during the second quarter of fiscal year 2025.
DAYVIGO works by targeting the orexin neurotransmitter system, which plays a key role in regulating the sleep-wake cycle. The medication binds competitively to both orexin receptor subtypes, OX1R and OX2R, with a stronger inhibitory effect on OX2R. By suppressing the activity of these receptors, particularly OX2R, DAYVIGO reduces both REM and non-REM sleep drive. This mechanism is believed to support faster sleep onset and improved sleep maintenance, helping patients achieve more restful and uninterrupted sleep.
The approval in China is based on the results of three pivotal Phase 3 clinical trials: SUNRISE 1 (NCT02783729) and SUNRISE 2 (NCT02952820)—global studies involving around 2,000 adult patients with insomnia—as well as Study 311 (NCT04549168), a Phase 3 trial conducted within China.
Insomnia is defined as persistent difficulty with falling asleep, staying asleep, or both, despite adequate opportunity for rest. These symptoms must occur at least three times per week for over a month and often lead to daytime fatigue, difficulty concentrating, and irritability. In China, insomnia affects approximately 15.0% of the adult population—equating to about 172.5 million people.DAYVIGO has already received approval in 22 countries and regions, including Japan, the United States, Canada, Australia, and several other Asian nations.Eisai remains committed to expanding access to DAYVIGO worldwide, aiming to improve quality of life for people with insomnia by helping restore daytime functioning through fast sleep onset and sustained, high-quality sleep
