Suvorexant

The global prevalence of insomnia disorder is increasing year by year. Long-term sleep deprivation not only reduces the quality of life, but also induces multiple chronic diseases such as cardiovascular and metabolic diseases. Most traditional sedative-hypnotics exert their effects through the γ-aminobutyric acid pathway, which is prone to drug resistance, hangover effect and addiction risk. As the world's first approved orexin receptor antagonist hypnotic, suvorexant can specifically block the binding of orexin to OX1 and OX2 receptors, and improve sleep by down-regulating the wake-promoting signaling pathway. Different from the central inhibition mechanism of traditional drugs, it can not only shorten the time to fall asleep and prolong the total sleep duration, but also will not significantly affect the cognitive function and mental state of the next day. It is suitable for adult insomnia patients with difficulty falling asleep and sleep maintenance disorder, especially for people with low tolerance to the adverse reactions of traditional hypnotics.

Driven by the increase in the prevalence of insomnia and the growing demand of patients for low-addiction hypnotics, the global market size of suvorexant had exceeded 1.3 billion US dollars in 2023, with a compound annual growth rate of 8.2% in the past five years. At present, the domestic market is still dominated by the original research product, and no generic drug has been approved for marketing. With the continuous heating up of the domestic sleep economy, the clinical demand gap of this drug is gradually expanding. In 2024, the sales volume of suvorexant in domestic sample hospitals increased by more than 45% year-on-year. After the subsequent launch of generic drugs, it is expected to further sink the market and cover more primary insomnia patients.

The original research enterprise of suvorexant is Merck, with the trade name Belsomra. The expiration time of its core compound patent in the United States is 2029, and the expiration time of the compound patent in China is 2028. The main dosage form approved for the original research is tablet, with four specifications including 5mg, 10mg, 15mg and 20mg. It has been included in the FDA Reference Listed Drug Catalog, and also included in China's *Catalog of Reference Preparations for Chemical Drugs (Third Batch)*. In terms of API registration, there is currently no approved registration number of suvorexant API in A status in China. Only the registration applications for API submitted by the original research enterprise and a few enterprises are under review and approval. At present, only the original suvorexant tablets are approved for marketing in China. (Data as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for suvorexant API. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products support spot supply. Spot orders placed before 16:00 can be shipped on the same day, which can fully meet the full-process R&D needs of API enterprises and preparation R&D institutions such as impurity research and quality control.