Adverse event reports of seizure for insomnia medication from 1967 to 2023.

IF 3.9 2区 综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES
Tae Hyeon Kim, Kyeongmin Lee, Jiyoung Hwang, Suhyun Lee, Hyesu Jo, Hanseul Cho, Hayeon Lee, Hye Jeong Baek, Jiseung Kang, Christa J Nehs, Guillaume Fond, Laurent Boyer, Eun Kyoung Chung, Dong Keon Yon
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Abstract

Insomnia may negatively impact seizure control; however, the corresponding evidence remains limited. This study analyzed the seizure risk associated with various insomnia medications using a comprehensive pharmacovigilance database and identified safe options for patients at high risk of seizures. VigiBase, a database of adverse drug reaction reports from over 140 countries, comprises 35 million reports published from 1967 to 2023. Medications for insomnia include benzodiazepines, Z-drugs, antidepressants, atypical antipsychotics, first-generation H1 antagonists, orexin receptor agonists, melatonin, and melatonin receptor agonists. We assessed the association between insomnia medications and seizure risk by analyzing the reported odds ratio (ROR) with 95% confidence intervals (CI) and the information component (IC) with IC025. In total, 17,967 cases of seizures associated with insomnia medications were reported, revealing a significant association (ROR, 2.12 [95% CI, 2.09 to 2.15]; IC, 1.05 [IC025, 1.03]). Based on the mechanism of action, seizures were significantly associated with benzodiazepines (ROR, 2.56 [95% CI, 2.49 to 2.64]; IC, 1.34 [IC025, 1.29]), Z-drugs (ROR, 1.58 [1.49 to 1.69]; IC, 0.66 [0.56]), antidepressants (ROR, 2.52 [2.43 to 2.61]; IC, 1.32 [1.26]), atypical antipsychotics (ROR, 1.92 [1.88 to 1.97]; IC, 0.93 [0.89]), first-generation H1 antagonists (ROR, 2.08 [1.98 to 2.19]; IC, 1.05 [0.96]), and melatonin (ROR, 1.81 [1.49 to 2.20]; IC, 0.84 [0.51]). In contrast, orexin receptor antagonists (ROR, 0.81 [95% CI, 0.61 to 1.07]; IC, - 0.30 [IC025, - 0.77]) and melatonin receptor agonists (ROR, 1.20 [0.80 to 1.81]; IC, 0.26 [- 0.44]) showed no significant association with seizures. Although the disproportionality analysis did not allow causal interpretation, our study highlights significant variations in seizure signal among insomnia medications.

1967 - 2023年失眠症药物发作不良事件报告。
失眠可能对癫痫发作的控制产生负面影响;然而,相应的证据仍然有限。本研究使用综合药物警戒数据库分析了与各种失眠药物相关的癫痫发作风险,并确定了高风险癫痫发作患者的安全选择。VigiBase是一个来自140多个国家的药物不良反应报告数据库,包括1967年至2023年发表的3500万份报告。治疗失眠的药物包括苯二氮卓类药物、z型药物、抗抑郁药、非典型抗精神病药、第一代H1拮抗剂、食欲素受体激动剂、褪黑激素和褪黑激素受体激动剂。我们通过95%可信区间(CI)分析报告的优势比(ROR)和IC025分析信息成分(IC)来评估失眠药物与癫痫发作风险之间的关系。总共报告了17,967例癫痫发作与失眠药物相关的病例,显示出显著的相关性(ROR, 2.12 [95% CI, 2.09至2.15];[c], 1.05 [c], 1.03。基于作用机制,癫痫发作与苯二氮卓类药物显著相关(ROR, 2.56 [95% CI, 2.49至2.64];IC, 1.34 [IC025, 1.29]), Z-drugs (ROR, 1.58 [1.49 ~ 1.69];IC, 0.66[0.56]),抗抑郁药(ROR, 2.52 [2.43 ~ 2.61];IC, 1.32[1.26]),非典型抗精神病药物(ROR, 1.92 [1.88 ~ 1.97];IC, 0.93[0.89]),第一代H1拮抗剂(ROR, 2.08 [1.98 - 2.19];IC, 1.05[0.96]),褪黑素(ROR, 1.81[1.49至2.20];Ic, 0.84[0.51])。相比之下,食欲素受体拮抗剂(ROR, 0.81 [95% CI, 0.61至1.07];IC, - 0.30 [IC025, - 0.77])和褪黑激素受体激动剂(ROR, 1.20[0.80至1.81];IC(0.26[- 0.44])与癫痫发作无显著相关性。尽管歧化分析不允许因果解释,但我们的研究强调了失眠药物在癫痫发作信号方面的显著差异。
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来源期刊
Scientific Reports
Scientific Reports Natural Science Disciplines-
CiteScore
7.50
自引率
4.30%
发文量
19567
审稿时长
3.9 months
期刊介绍: We publish original research from all areas of the natural sciences, psychology, medicine and engineering. You can learn more about what we publish by browsing our specific scientific subject areas below or explore Scientific Reports by browsing all articles and collections. Scientific Reports has a 2-year impact factor: 4.380 (2021), and is the 6th most-cited journal in the world, with more than 540,000 citations in 2020 (Clarivate Analytics, 2021). •Engineering Engineering covers all aspects of engineering, technology, and applied science. It plays a crucial role in the development of technologies to address some of the world''s biggest challenges, helping to save lives and improve the way we live. •Physical sciences Physical sciences are those academic disciplines that aim to uncover the underlying laws of nature — often written in the language of mathematics. It is a collective term for areas of study including astronomy, chemistry, materials science and physics. •Earth and environmental sciences Earth and environmental sciences cover all aspects of Earth and planetary science and broadly encompass solid Earth processes, surface and atmospheric dynamics, Earth system history, climate and climate change, marine and freshwater systems, and ecology. It also considers the interactions between humans and these systems. •Biological sciences Biological sciences encompass all the divisions of natural sciences examining various aspects of vital processes. The concept includes anatomy, physiology, cell biology, biochemistry and biophysics, and covers all organisms from microorganisms, animals to plants. •Health sciences The health sciences study health, disease and healthcare. This field of study aims to develop knowledge, interventions and technology for use in healthcare to improve the treatment of patients.
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