Dimdazenil: First Approval

Edinoff AN, Nix CA, Hollier J, et al. Benzodiazepines: uses, dangers, and clinical considerations. Neurol Int. 2021;13(4):594–607.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Riemann D, Espie CA, Altena E, et al. The European Insomnia Guideline: an update on the diagnosis and treatment of insomnia 2023. J Sleep Res. 2023;32(6): e14035.

Article  PubMed  Google Scholar 

Kemp JA, Baur R, Sigel E. EVT 201: a high affinity, partial positive allosteric modulator of GABAA receptors with preference for the α1-subtype [abstract no. 0104]. Sleep. 2008;31(Suppl):A34.

Google Scholar 

Walsh JK, Thacker S, Knowles LJ, et al. The partial positive allosteric GABAA receptor modulator EVT 201 is efficacious and safe in the treatment of adult primary insomnia patients. Sleep Med. 2009;10(8):859–64.

Article  PubMed  Google Scholar 

Wang F, He J, Zhou Y, et al. A phase 1 study of dimdazenil to evaluate the pharmacokinetics, food effect and safety in Chinese healthy subjects. Front Pharmacol. 2023. https://doi.org/10.3389/fphar.2023.1226014.

Article  PubMed  PubMed Central  Google Scholar 

Zhejiang Jingxin Pharmaceutical. Dimdazenil capsules: Chinese prescribing information. 2023. https://www.cde.org.cn/. Accessed 7 Mar 2024.

National Medical Products Administration. State Food and Drug Administration approves dimdazenil capsules for marketing. 2023. https://www.nmpa.gov.cn/directory/web/nmpa/zhuanti/ypqxgg/gggzjzh/20231129143126185.html. Accessed 7 Mar 2024.

Evotec AG. Evotec licenses phase II insomnia candidate to Jingxin Pharma for development in China [media release] 28 Oct 2010. http://www.evotec.com.

Stanley N, Boyle J, Hunneyball I, et al. A placebo controlled, randomised, double-blind, 4 way cross-over study of 3 doses of EVT201 (2.5 mg, 5 mg and 10 mg) on aspects of sleep and morning after performance using a traffic noise model of sleep disturbance [abstract no. 0750]. Sleep. 2006;29(Suppl):A255.

Google Scholar 

Boyle J, Stanley N, Hunneyball I, et al. A placebo controlled, randomised, double-blind, 5 way cross-over study of 4 doses of EVT 201 on subjective sleep quality and morning after performance in a traffic noise model of sleep disturbance [abstract no. 0769]. Sleep. 2007;30(Suppl):A262–3.

Google Scholar 

Stanley N, Wright N, Boyle J, et al. A placebo controlled, randomised, double-blind, 5 way cross-over study of 4 doses of EVT 201 in a traffic noise model of sleep disturbance: PSG and spectral analysis of sleep [abstract no. 0771]. Sleep. 2007;30(Suppl):A263.

Google Scholar 

Huang Z, Zhan S, Chen C, et al. Efficacy and safety of dimdazenil in adults with insomnia disorder: results from a multicenter, randomized, double-blind, placebo-controlled, phase III trials. Sleep. 2023;47(2):zsad272.

Article  PubMed Central  Google Scholar 

Li Y, Zhang R, Zhou Y, et al. Efficacy and safety of dimdazenil in the adult insomnia patients: a phase II randomized, multicenter, double-blind, placebo-controlled, parallel-group study. Sleep. 2023;47(2):zsad271.

Article  PubMed Central  Google Scholar 

Walsh JK, Salkeld L, Knowles LJ, et al. Treatment of elderly primary insomnia patients with EVT 201 improves sleep initiation, sleep maintenance, and daytime sleepiness. Sleep Med. 2010;11(1):23–30.

Article  PubMed  Google Scholar 

留言 (0)

沒有登入
gif