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Efficacy and safety of Dimdazenil in adults with insomnia disorder: results from a multicenter, randomized, double-blind, placebo-controlled, phase III trials

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机构： [1]Neurology Department, Xuanwu Hospital Capital Medical University, Beijing, 100053, China. [2]Beijing Key Laboratory of Neuromodulation, Beijing, 100053, China. [3]Shanghai Research Institute, Zhejiang Jingxin Pharmaceutical Co., Ltd, Shanghai, 201203, China. [4]zhejiang Jingxin Pharmaceutical Co., Ltd, Zhejiang, 310020, China.

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关键词： GABAA receptors partial positive allosteric modulator Dimdazenil insomnia disorder polysomnography

摘要：

To evaluate the efficacy and safety of Dimdazenil, a novel partial positive allosteric modulator for GABAA receptor in adults with insomnia disorder.This was a 2-week, multicenter, randomized, double-blind, placebo-controlled parallel-group phase III study of Dimdazenil. The primary efficacy outcome was total sleep time (TST) analyzed by polysomnography (PSG) on Day 13/14. Latency to persistent sleep (LPS), sleep efficiency (SE), and wake after sleep onset (WASO) were analyzed in the same way by polysomnography (PSG). The other secondary outcomes included the average subjective sleep latency (sSL), subjective total sleep time (sTST), subjective sleep efficiency (sSE), subjective wake after sleep onset (sWASO) and subjective number of awakenings (sNAW) were analyzed from sleep diary data, and the insomnia severity index (ISI) was also assessed. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.A total of 546 participants with insomnia (age ≥18 years) were randomized (2:1), received treatment with an oral dose of Dimdazenil (2.5 mg) or placebo and analyzed. Compared to baseline and placebo, Dimdazenil demonstrated significant improvements in PSG measures, increased TST (71.09, 31.68 min, respectively; both p <0.001), increased SE (13.26%, 5.55%, respectively; both <0.001), reduced WASO (49.67, 20.16 min, respectively; both p <0.001), reduced LPS (21.65min, p <0.001; 6.46 min, p =0.023). Compared to placebo, Dimdazenil also improved key self-reported measures of sTST (18.33 min, p <0.001), sWASO (14.60 min, p <0.001), sSL (4.23 min, p <0.001), sSE (2.97%, p <0.001), sNAW (0.29, p <0.001). Participants treated with Dimdazenil reported a significant improvement in insomnia severity index (ISI). Dimdazenil was well tolerated. The majority of TEAEs were mild or moderate. There were no clinically-relevant treatment-related serious adverse events and no deaths.Dimdazenil of 2.5 mg provided significant benefit on sleep maintenance and sleep onset in individuals with insomnia disorder versus placebo, with a favorable safety profile and was well tolerated.© The Author(s) 2023. Published by Oxford University Press on behalf of Sleep Research Society.

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出版当年[2023]版：

大类 | 2 区医学

小类 | 2 区临床神经病学 2 区神经科学

最新[2025]版：

大类 | 2 区医学

小类 | 2 区临床神经病学 2 区神经科学

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出版当年[2022]版：

Q1 CLINICAL NEUROLOGY Q1 NEUROSCIENCES

最新[2024]版：

Q1 CLINICAL NEUROLOGY Q1 NEUROSCIENCES

影响因子： 4.9 最新[2024版] 5.4 最新五年平均 5.6 出版当年[2022版] 6 出版当年五年平均 6.313 出版前一年[2021版] 5.3 出版后一年[2023版]

第一作者：

第一作者机构： [1]Neurology Department, Xuanwu Hospital Capital Medical University, Beijing, 100053, China. [2]Beijing Key Laboratory of Neuromodulation, Beijing, 100053, China.

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通讯作者：

通讯机构： [1]Neurology Department, Xuanwu Hospital Capital Medical University, Beijing, 100053, China. [2]Beijing Key Laboratory of Neuromodulation, Beijing, 100053, China.

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Efficacy and safety of Dimdazenil in adults with insomnia disorder: results from a multicenter, randomized, double-blind, placebo-controlled, phase III trials

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