Nitrazepam

In the clinical treatment of neurodegenerative diseases and mental disorders, benzodiazepines are among the core medications for controlling anxiety and seizure episodes. Nitrazepam is a classic variety in this category that has both sedative and anti-epileptic effects. It binds to the γ-aminobutyric acid A receptor in the central nervous system to enhance the conduction effect of inhibitory neurotransmitters. On the one hand, it can relieve insomnia symptoms caused by various anxiety disorders and improve the problem of difficulty in maintaining sleep in adult patients. On the other hand, it can also be used as an adjuvant medication for seizure control in infantile spasms and myoclonic epilepsy, and has a wide range of application scenarios in pediatric neurology and psychiatry clinics.

The current global market size of nitrazepam preparations is stable at around USD 420 million, with a compound annual growth rate of approximately 2.1%. The growth momentum mainly comes from the rising prevalence of sleep disorders among the middle-aged and elderly population, as well as the improvement of the coverage rate of standardized epilepsy treatment in developing countries. As a classic drug that has been on the market for many years, the global market is dominated by generic drug supplies. Europe and India are the major export regions of nitrazepam active pharmaceutical ingredients (APIs). Previously, the domestic market had long relied on imported API supplies. In the past three years, with the technological breakthroughs of local enterprises, the localization rate has increased to around 37%.

The original research enterprise of nitrazepam is Roche, and the original brand name is Mogadon. Its core compound patent expired globally in 1976. The main dosage form approved for the original drug is tablet, with specifications of 5mg and 10mg. The 5mg specification has been included in the FDA Reference Listed Drug Catalogue, and is also included in the *Catalogue of Reference Preparations for Chemical Drugs (Third Batch)* of China. As of now, there are 3 nitrazepam API registration records on China's CDE API Registration Platform, including 1 for domestic production and 2 for overseas production, all with the status of A (approved for use in marketed preparations); 21 domestic enterprises have obtained marketing approval for nitrazepam tablets. (Data as of May 2025, please refer to the official CDE website for the latest information)

For the quality research needs of nitrazepam APIs and preparations, CATO can provide a full set of impurity reference standards for this variety, covering all quality control requirements such as related substance inspection and content determination. Most products are in stock. Spot orders placed before 16:00 can be shipped on the same day. All products meet the regulatory requirements of multiple regions including the Chinese Pharmacopoeia and FDA, and can support enterprises to complete relevant research work such as API registration and preparation consistency evaluation.