Eisai’s DAYVIGO® Receives Approval in China for Adult Insomnia
Tuesday, May 27, 2025
Eisai has received regulatory approval in China for its anti-insomnia medicine DAYVIGO® (lemborexant).
DAYVIGO is a dual orexin receptor antagonist. It blocks orexin signals in the brain, which are central to the sleep-wake cycle. By competitively binding to both orexin receptor subtypes (OX1R and OX2R)—with a stronger effect on OX2R—the medicine improves both sleep onset and maintenance by dampening wakefulness signals affecting REM and non-REM sleep.
Insomnia is defined as difficulty in falling or staying asleep at least three times a week for a month or more, despite adequate opportunity for rest. It can lead to fatigue, poor concentration and irritability. In China, about 15 per cent of adults—an estimated 172.5 million people—are thought to experience the condition.
This marks the entry of the company’s in-house-developed drug into the Chinese market for treating adults with insomnia.
The application for approval drew on data from three Phase 3 studies. Two global trials, SUNRISE 1 and SUNRISE 2, involved roughly 2,000 adults with insomnia. A third trial, Study 311, assessed the drug’s safety and efficacy in a Chinese population.
With approvals now in 23 countries and regions, including Japan, the United States, Canada and Australia, Eisai aims to offer DAYVIGO as a new option for people with insomnia worldwide and to support better sleep quality and daytime function.
Source: eisai.com
