Zopiclone

In response to the clinical medication demand of adult patients with short-term insomnia, non-benzodiazepine sedative-hypnotics have gradually replaced traditional benzodiazepines due to their advantages of low addiction risk and mild residual effects, and zopiclone is one of the representative varieties of such drugs. It selectively binds to the benzodiazepine binding site of the γ-aminobutyric acid A receptor, enhances the conduction of inhibitory neurotransmitters, can significantly shorten sleep onset latency and prolong total sleep time, while having little impact on cognitive function the next day. It is suitable for patients with transient and short-term insomnia caused by various reasons, and can also be used for short-term adjuvant treatment of chronic insomnia, making it a commonly recommended drug for initial clinical treatment of insomnia at present.

The current global market size of sedative-hypnotics has exceeded 45 billion US dollars, of which non-benzodiazepines account for more than 60%, and zopiclone and eszopiclone together account for about 18% of the market share of non-benzodiazepine sedative-hypnotics. The sales of zopiclone in terminals of Chinese public medical institutions maintain a steady annual growth rate of about 7%, and the sales exceeded 1.2 billion yuan in 2023. The competition in the domestic market is dominated by generic drugs. More than 20 enterprises have obtained the production approval for zopiclone preparations, and the localization rate of API has reached more than 95%, among which enterprises in East China and North China are the main suppliers. In addition, multiple provinces have included the oral regular-release dosage form of zopiclone in the scope of provincial centralized volume-based procurement, with an average price reduction of more than 60% for the selected products, and the clinical accessibility has been greatly improved.

The original developer of zopiclone is Sanofi, with the original brand name Imovane, and its core compound patent expired worldwide in 1999. The main dosage form approved for the original product is tablet, with specifications of 3.75mg and 7.5mg. It has been included in the FDA Orange Book Reference Listed Drug Catalog, and also included in the *Catalogue of Reference Preparations for Chemical Drugs* of China. In terms of domestic API registration, as of now, 17 enterprises have completed the registration of zopiclone API in CDE (status A), which can be legally supplied to preparation manufacturers; on the preparation side, there are 23 domestic approvals for oral regular-release dosage forms of zopiclone, and the original product has not yet been approved for marketing in China. (Data as of October 2024, please refer to the official website of CDE for the latest information)

Impurity control in the process of drug R&D and production is the core link to ensure the quality and safety of zopiclone. CATO provides a full set of impurity reference standards for this API, and most products are in stock. Orders for in-stock products placed before 16:00 will be shipped on the same day. All products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the full-process needs of API enterprises and preparation manufacturers for quality research, stability study, registration and declaration, etc.