Detailed information on which country is Lemborexant manufactured?

Lemborexant is an innovative sleep-aid drug developed and produced by the Japanese pharmaceutical company Eisai Co., Ltd. The drug was first approved by the U.S. Food and Drug Administration (FDA) at the end of 2019, under the trade name Dayvigo, and is used to treat adult insomnia, especially patients with difficulty falling asleep or maintaining sleep. The research and development of Lebraxen marks a major breakthrough for Japanese pharmaceutical companies in the field of central nervous system drugs, and also represents a shift in sleep drug research and development from traditional sedative-hypnotics to neuromodulatory drugs.

Unlike traditional benzodiazepines or non-benzodiazepine hypnotics, leborexan does not achieve sedation by enhancing the inhibitory effect ofGABA receptors. Instead, it acts as a "dual orexin receptor antagonist" by blocking orexin-1 and orexin-2 receptor signaling in the arousal system, thereby reducing the brain's driving force to wake up from the source. This mechanism is closer to the regulation of "natural sleep", so it has less interference with sleep structure and the risk of addiction is relatively low.

Globally, Leborexan is developed and promoted by Eisai Corporation. In the United StatesAfter FDA approval, the Japanese Ministry of Health, Labor and Welfare also approved its marketing in 2020 for the treatment of insomnia caused by abnormalities in the arousal system. The successful launch in the US and Japanese markets makes it the second representative drug to be launched with the DORA mechanism after Suvorexant (trade name: Belsomra). Currently, the European Medicines Agency (EMA) is also evaluating its marketing application in Europe.

In terms of production, Eisai leads the drug's API synthesis and formulation process development at its Tsukuba Research Center and Tokyo headquarters in Japan. Its international sales and distribution are completed in cooperation with its U.S. subsidiaryEisai Inc. Dayvigo has been launched in the United States, Canada, Australia and some Asian countries, forming a global supply system.

Reference materials:https://medlineplus.gov/druginfo/meds/a620039.html