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A class 1 new drug Dimdazenil was approved in China

2025-01-03

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A class 1 new drug Dimdazenil was approved in China

Insomnia is a serious problem all around the world. Many researchers of pharmaceutical companies make great efforts to study new drugs for insomniacs. Recently,China's National Medical Products Administration (NMPA) approved on the market of Didasenil capsule, a Class 1 innovative drug declared by Zhejiang Jingxin Pharmaceutical Co., LTD. The drug is suitable for the short-term treatment of patients with insomnia disorders. Dimdazenil belongs to the benzodiazepine and is a partial positive allosteric regulator of γ-aminobutyric acid (GABAA) receptor, which can promote sleep by partially activating GABAA receptor.

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Dimdazenil (308239-86-3)

However, Didasenil was first discovered by Roche and later developed mainly by Evotec in Germany. Related patents: EP-00672666, WO2000069858A1.

Relative data

Compared with the average half-life of the optimal dose of short-acting benzodiazepine receptor agonists (such as Zolpidem, zaliplon and triazolam) of 1 to 3 hours, the elimination half-life of desidasinib was longer (3 to 4 hours) and the duration of sleep maintenance was longer. Compared with dexzopiclone, Temazepam and other intermediate-acting BzRAs with an average half-life of 6 hours or more, Didasinib is less likely to residual effect . Compared with traditional benzodiazepine GABA receptor complete agonists, dedasenil has obvious advantages in terms of movement disorders, aftereffects, tolerance, ethanol interaction, physical dependence, memory impairment and other adverse effects.

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In the list of narcotic drugs and psychotropic drugs adjusted by the State Drug Administration, the Ministry of Public Security and the National Health Commission in September this year, Didasini was included in the second category of psychotropic drugs, and the adjusted list was implemented on October 1 this year. Although the safety of didasenil is improved over benzodiazepines, long-term use may still cause dependence and must be taken strictly according to the dosage under the guidance of a doctor.


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