Trazodone

Depressive disorder is one of the mental diseases with the highest prevalence in the world. Patients are often accompanied by comorbid symptoms such as sleep disturbance and anxiety, and traditional antidepressants are often difficult to simultaneously achieve both mood improvement and sleep regulation. Trazodone belongs to serotonin antagonist and reuptake inhibitor (SARI). On the one hand, it exerts antidepressant and anxiolytic effects by blocking 5-HT2A receptors and inhibiting serotonin transporter; on the other hand, its moderate affinity for histamine H1 receptors can effectively improve sleep quality without the addiction risk of benzodiazepines. In addition to being used for various types of depressive disorders in adults in clinical practice, it is also recommended by guidelines for patients with depression accompanied by insomnia and anxiety disorder comorbid with depression, and its medication safety in the elderly population has also been widely verified.

The global trazodone market size had exceeded USD 1.2 billion in 2023, with a compound annual growth rate maintained at around 5.2%. The growth momentum mainly comes from the improvement of the diagnosis and treatment penetration rate of mental diseases at the primary level and the release of demand for comorbidity medication. For the domestic market, with the implementation of the fifth batch of national centralized drug procurement in 2022, the winning bid price of trazodone preparations has dropped by more than 70%. The domestic terminal medication size had exceeded RMB 1.8 billion in 2024, and the market share of domestic generic drugs has increased from 32% before the centralized procurement to 78%, and the demand for active pharmaceutical ingredients has entered a period of rapid growth accordingly.

The original developer of trazodone is Menarini Group, with the original brand name "Mesyrel". Its core compound patent expired globally in 2003. At present, the dosage form in major global markets is mainly oral tablet, with three specifications including 50mg, 100mg and 150mg. The original tablet has been included in both the *Catalogue of Reference Preparations of Chemical Drugs* of China and the FDA Reference Preparation Catalogue. As of June 2025, there are a total of 9 registered A-status approval numbers for trazodone API in China, and more than 20 enterprises have been approved for the production of trazodone preparations, covering multiple dosage forms such as tablets and sustained-release tablets. (Data is as of June 2025, please refer to the official website of CDE for the latest information)

CATO provides a full set of impurity reference standards for trazodone API, which can simultaneously meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA. Most products are in regular stock, and orders placed before 16:00 can be shipped on the same day, which can provide stable reference standard supply support for pharmaceutical enterprises in API quality research and preparation consistency evaluation.