Global launch time and approved countries of Dali Rayson

Daridorexant is an innovative orexin receptor antagonist and belongs to the new generation of non-benzodiazepine drugs for the treatment of insomnia. The drug was developed by the Swiss pharmaceutical company Idorsia. It aims to block the Orexin-1 and Orexin-2 receptor pathways in the brain, inhibit wake signals, and help patients fall asleep more naturally and maintain sleep throughout the night. Compared with traditional sedative drugs, DaliRasen does not rely on the GABA receptor system and has a lower risk of addiction and daytime sleepiness.

The drug was first approved by the US FDA in January 2022 for the treatment of adult insomnia patients with disorders of falling asleep and/or maintaining sleep. In May 2022, Dali Rexon was officially launched on the U.S. market under the trade name Quviviq, and was classified as a Schedule IV controlled drug, indicating that it has a moderate potential for abuse, but is safer than traditional sleeping pills. In April of the same year, DaliRasen was also approved for use in the EU, becoming the first orexin receptor antagonist to be marketed in the EU, marking the recognition of the clinical status of this mechanism of drug in the field of treating insomnia in Europe.

In addition to the European and American markets, DaliRaxon has also successively advanced the review process in Canada, Japan, Australia and other countries. It is worth noting that on June 20, 2025, the original drug of DaliRasen was officially approved for marketing by the China National Medical Products Administration (NMPA) under the name of "DaliRasen Hydrochloride Tablets". The trade name is "QUVIVIQ" and was authorized to be introduced by the original developer. As a country where the prevalence of insomnia is rising rapidly in the world, China's introduction of new drugs with this type of mechanism will provide more diversified treatment tools for clinical use, especially for patients with poor efficacy or poor tolerance of traditional drugs.

At present, DaliRasen has not yet been launched on a large scale in China, and details such as price and medical insurance reimbursement have not yet been announced, and market accessibility needs to be improved. As the global awareness of sleep disorders increases, DaliRasen has become a representative drug that has attracted much attention in the field of international insomnia treatment, and its global layout continues to expand.

Reference materials:https://www.quviviq.com/