Eszopiclone

Insomnia is a highly prevalent sleep disorder globally, and its long-term progression can induce various complications such as anxiety and cognitive decline. The clinical demand for sedative-hypnotic drugs with fast onset and high safety continues to rise. Eszopiclone belongs to non-benzodiazepine sedative-hypnotics, which exerts its effect by selectively agonizing the α subunit of γ-aminobutyric acid A receptor. It can not only shorten sleep latency and prolong total sleep time, but also rarely causes next-day hangover effect, with drug dependence significantly lower than that of traditional benzodiazepines. It is a first-line drug for clinical treatment of adult insomnia, especially suitable for elderly patients with low tolerance to residual adverse reactions and people who need to rapidly improve sleep quality.

In recent years, the global market size of eszopiclone preparations has been stable at more than 1.2 billion US dollars, and the annual growth rate of the Chinese market has maintained in the range of 8%-10%. In 2023, the terminal sales of domestic public medical institutions exceeded 1.8 billion yuan. In terms of the competitive landscape, the original research product still accounts for about 32% of the market share, and there are more than 15 domestic generic drug enterprises, among which 4 enterprises have their preparation products passed the consistency evaluation. With the expansion of the coverage of provincial centralized procurement, the market share of generic drugs is continuously increasing. There is no publicly verifiable data on the market size of the segmented API market at present.

The original research enterprise of eszopiclone is Sanofi-Aventis of the United States, with the original trade name Lunesta. Its core compound patent in the United States expired in 2010, and the crystal patent in China expired in 2014. The main dosage form approved by the original research is tablet, with specifications including 1mg, 2mg and 3mg. The original research tablet has been included in the *Catalogue of Reference Preparations for Chemical Drugs* of China, and is also a reference preparation recognized by the FDA. As of the search time point, there are more than 20 eszopiclone API registration numbers on the API registration platform of China CDE, among which 12 are in status A (can be used in marketed preparations), and several domestic enterprises have obtained the marketing approval for eszopiclone tablets. (Data as of October 2024, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for eszopiclone API, most of which are available in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products fully comply with the regulatory requirements of the Chinese Pharmacopoeia and FDA, and can fully support the whole process of API R&D, quality research and consistency evaluation of pharmaceutical enterprises.