(Yicai) May 28 -- China has approved the use of Dayvigo, a new insomnia therapy developed by Japanese pharmaceutical company Eisai.

Dayvigo can be used in China for the treatment of adults with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance, the Tokyo-based firm announced yesterday. The medicine is expected to hit the Chinese market in the second quarter of fiscal year 2025, which runs from July 1 to Sept. 30.

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. So far, it has been approved for the treatment of insomnia in 22 countries and regions, including Japan, the United States, Canada, and Australia.

Eisai submitted an application for approval, which was accepted in January last year, based on the outcome of two pivotal Phase III clinical studies conducted globally in a total of about 2,000 adult patients with insomnia, and a Phase III clinical study conducted in China.

Dayvigo's mechanism is innovative and safer than traditional sedative drugs such as benzodiazepines, Chen Jun, chief physician at the Shanghai Mental Health Center, told Yicai.

Benzodiazepines can lead to psychological and physical dependence and cause side effects, including muscle relaxation and even memory impairment or other cognitive damages with long-term use, Chan explained.

In China, drugs for insomnia are strictly controlled and cannot be prescribed arbitrarily, Chen said. "The first step in treating insomnia is adjusting sleep habits and psychotherapy," he noted. "Only after these methods are ineffective, the use of drugs should be considered."

Insomnia is characterized by difficulty falling asleep, staying asleep, or both despite an adequate opportunity to sleep, which has occurred at least three times a week for at least one month, and which can lead to fatigue, difficulty concentrating, and irritability, according to Eisai.

The prevalence of insomnia among adults in China is reported to be 15 percent, with around 172.5 million people thought to suffer from insomnia, Eisai estimated.

Editors: Dou Shicong, Futura Costaglione