Estazolam

Sedative-hypnotic drugs are core clinical medications for common neuropsychiatric symptoms such as anxiety disorders and insomnia. Among them, benzodiazepines have long occupied the mainstream clinical position due to their advantages of fast onset and high safety, and estazolam is a classic intermediate-acting preparation in this category. It acts on the γ-aminobutyric acid receptors of the central nervous system to enhance the conduction effect of inhibitory neurotransmitters, and has the effects of anti-anxiety, sedation and hypnosis, anti-convulsion and skeletal muscle relaxation. Clinically, it is mainly used for the relief of various anxiety states, and the treatment of insomnia in patients with difficulty falling asleep or sleep maintenance disorder. It can also be used as an adjuvant drug for seizure control and preoperative sedation. The applicable population covers adult patients and some elderly patients for whom the benefit is greater than the risk after evaluation, and its clinical use has been supported by decades of evidence-based medical evidence.

At present, the global market size of sedative-hypnotic drugs is growing steadily. Among them, benzodiazepines, as basic medications, account for about 18% of the segment market share, and the annual clinical usage of estazolam in China is stable at more than 50 million tablets. Due to its early launch time and high clinical recognition, there are more than 30 domestic generic drug manufacturers. It is included in the National Essential Medicine List and also included in the Class A Medical Insurance List. In the 2022 provincial centralized drug procurement, the winning bid price of this product decreased by an average of 42% compared with the original purchase price, and the accessibility for patients has been greatly improved. The overall market supply presents a competitive pattern dominated by generic drugs with stable prices.

The original developer of estazolam is Roche Pharmaceuticals of Switzerland, with the original brand name "Estazolam", and the core compound patent expired worldwide in 1985. At present, the main dosage form of the original drug on the market is oral tablet, with specifications of 1mg and 2mg. Both the 1mg and 2mg tablets have been included in the FDA Reference Listed Drug Catalog, while the domestic Reference Listed Drug Catalog has not yet included the original product, and domestic generic drugs that have passed the consistency evaluation are used as reference preparations. As of now, 23 domestic enterprises have obtained A status identification for their estazolam API through CDE registration, which can be associated with preparation declaration or marketed for sale. All domestically approved estazolam preparations are oral tablets, and 12 enterprises have passed the consistency evaluation for their relevant preparations. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for estazolam API, which can fully meet the needs of different R&D scenarios such as impurity research, stability study, and quality standard establishment. Most products are in stock, and in-stock products ordered before 16:00 will be shipped on the same day. All reference standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can provide stable and reliable reference standard support for the R&D and quality control links of APIs and preparations of relevant enterprises.