Zolpidem

As a representative variety of non-benzodiazepine sedative-hypnotics, zolpidem acts on the α1 subunit of the γ-aminobutyric acid type A receptor with high selectivity. While rapidly inducing sleep, it greatly reduces the next-day hangover feeling, addiction risk and respiratory depression risk that are common with traditional benzodiazepine drugs. Clinically, it is mainly used for the treatment of occasional and temporary insomnia, suitable for adult patients with difficulty falling asleep, and can also improve the sleep onset disorder of people with chronic insomnia in the short term. It is a first-line hypnotic drug recommended by global insomnia treatment guidelines.

The global zolpidem market size has maintained steady growth in recent years. In 2023, the market size was approximately USD 1.47 billion, with a compound annual growth rate maintained at around 2.8%. In terms of the domestic market, with the increase in the prevalence of insomnia and the improvement of public attention to sleep health, the total sales of zolpidem in domestic public medical institutions and retail terminals reached RMB 1.82 billion in 2023, with an annual growth rate of 6.3%. At present, the market is still dominated by the original research products. 16 domestic enterprises have obtained the approval documents of generic drug preparations, among which 11 products have passed the consistency evaluation. The price reduction of the varieties selected in the centralized procurement exceeds 85%, and the accessibility at the grassroots level continues to improve.

The original research enterprise of zolpidem is Sanofi, and the original brand name is "Stilnox". Its core compound patent expired globally in 2007, and the Chinese preparation patent expired in 2019. The main dosage form of the original research product is zolpidem tartrate tablets, with specifications of 5mg and 10mg, which have been included in the Chinese *Catalogue of Chemical Reference Preparations* and the FDA Reference Preparation Catalogue. Up to now, there are 19 zolpidem API registration records on the API registration platform of China CDE, among which 8 are in status A (activated). There are 21 zolpidem preparation approval documents in China, covering various dosage forms such as conventional tablets, orally disintegrating tablets and sustained-release tablets. (Data as of November 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of zolpidem impurity reference standards, covering the whole research chain including synthetic starting materials, intermediates and degradation impurities. Most of the products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can be directly used for API quality research, stability investigation and registration declaration, effectively shortening the R&D and declaration cycle of enterprises.