Ramelteon

Insomnia disorder is a highly prevalent neuropsychiatric disease worldwide. Traditional benzodiazepines are prone to adverse reactions such as dependence and residual sedative effects, and there has been a long-standing clinical demand for safer medication. Ramelteon is a hypnotic drug of the melatonin receptor agonist class. It highly selectively agonizes MT1 and MT2 receptors, exerts a hypnotic effect by regulating circadian rhythm, has no addiction liability and no next-day residual sedative effect. It is currently the only sedative-hypnotic drug that is not listed as a psychotropic controlled drug, and is suitable for the treatment of insomnia characterized by difficulty falling asleep, especially for elderly patients, people at high risk of drug dependence, and occupational groups who need to avoid decreased reactivity the next day.

According to public data, the domestic market size of sedative-hypnotics exceeded 9 billion yuan in 2023, among which the proportion of new non-benzodiazepine drugs continues to increase, with a compound annual growth rate remaining above 12%. Ramelteon is a representative variety of new rhythm-regulating hypnotics. At present, there are fewer than 10 generic drug enterprises that have obtained approval for ramelteon in China, and the market competition pattern is relatively loose. With the increase of residents' attention to the safety of insomnia treatment, its market penetration rate still has a large room for growth.

The original research enterprise of ramelteon is Takeda Pharmaceutical Company Limited of Japan, and the original trade name is Rozerem. The core compound patent of ramelteon will expire in the United States in 2028, while the compound patent in China has expired. The main dosage form approved for the original drug is tablet with a specification of 8mg, which has been included in the FDA Reference Listed Drug Catalog, and is also included in the *Catalog of Reference Preparations for Chemical Drugs* of China. Up to now, the ramelteon API of a number of Chinese enterprises has obtained A status through CDE registration, and more than 20 other enterprises have obtained marketing approval for ramelteon 8mg tablets. (Data as of June 2025, please refer to the official CDE website for the latest information.)

CATO provides a full set of impurity standards for ramelteon API, supporting the impurity reference requirements throughout the whole process from process R&D to registration and declaration. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. All standards meet the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can be directly used for quality research and submission of declaration materials, helping enterprises efficiently promote the development and marketing process of related ramelteon generic drugs.