Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS).

IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY
Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-06-03 DOI:10.1080/14740338.2024.2361300
Roger S McIntyre, Sabrina Wong, Angela T H Kwan, Taeho Greg Rhee, Kayla M Teopiz, Roger Ho, Bing Cao, Rodrigo B Mansur, Joshua D Rosenblat, Gia Han Le
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引用次数: 0

Abstract

Background: Package inserts for the FDA-approved dual orexin receptor antagonists (DORAs) suvorexant, lemborexant and daridorexant state that suicide risk should be monitored. It remains unknown whether suicidality is attributed to DORAs. We aim to evaluate suicidality associated with DORAs reported to the FDA Adverse Event Reporting System (FAERS).

Methods: The reporting odds ratio (ROR) was determined with trazodone as the control. Significant disproportionate reporting was determined when 95% confidence intervals (CIs) did not encompass 1.0. We used information components (ICs) to calculate the lower limit of the 95% CI (IC025). IC was significantly increased when the IC025 ≥0.

Results: Suvorexant (0.025 ROR), lemborexant (0.019 ROR) and daridorexant (0.002 ROR) were significantly associated with lower odds of reported completed suicides compared to trazodone (p < 0.05). There was no significantly increased RORs for the DORAs regarding suicidal ideation, depression suicidal, suicidal behavior and suicide attempts. Nonsignificant associations between all parameters of suicidality were observed for each DORA using IC025.

Conclusion: We did not find a significant association between any parameter of suicidality captured in the FAERS for each DORA. All persons treated for insomnia pharmacologically/non-pharmacologically should be evaluated for emergence/worsening of any suicidality aspect.

双奥曲肽受体拮抗剂(DORAs)与自杀之间的关系:向美国食品药品监督管理局不良事件报告系统(FAERS)提交的报告。
背景:美国食品和药物管理局(FDA)批准的双奥曲肽受体拮抗剂(DORAs)suvorexant、lemborexant 和 daridorexant 的包装说明书指出,应监测自杀风险。目前仍不清楚自杀是否可归因于 DORAs。我们的目的是评估向 FDA 不良事件报告系统(FAERS)报告的 DORA 相关自杀率:方法:以曲唑酮为对照,确定报告几率比(ROR)。当 95% 置信区间 (CI) 不包括 1.0 时,即判定为显著的报告不成比例。我们使用信息成分(IC)来计算 95% 置信区间的下限(IC025)。当IC025≥0.0时,IC明显增加:结果:与曲唑酮相比,Suvorexant(0.025 ROR)、lemborexant(0.019 ROR)和 daridorexant(0.002 ROR)与报告的完成自杀几率较低有显著相关性(P 025):我们没有发现每种 DORA 在 FAERS 中捕获的任何自杀参数之间存在明显关联。所有接受药物/非药物治疗的失眠症患者都应接受评估,以确定是否出现/加剧了任何自杀倾向。
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来源期刊
CiteScore
5.90
自引率
3.20%
发文量
97
审稿时长
6-12 weeks
期刊介绍: Expert Opinion on Drug Safety ranks #62 of 216 in the Pharmacology & Pharmacy category in the 2008 ISI Journal Citation Reports. Expert Opinion on Drug Safety (ISSN 1474-0338 [print], 1744-764X [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of drug safety and original papers on the clinical implications of drug treatment safety issues, providing expert opinion on the scope for future development.
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