Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the United States Food and Drug Administration Adverse Event Reporting System (FAERS).
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アブストラクト 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 (IC(025)). IC was significantly increased when the IC(025) >/=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 IC(025).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.ジャーナル名 Expert opinion on drug safety 投稿日 2024/5/28 投稿者 McIntyre, Roger S; Wong, Sabrina; Kwan, Angela T H; Rhee, Taeho Greg; Teopiz, Kayla M; Ho, Roger; Cao, Bing; Mansur, Rodrigo B; Rosenblat, Joshua D; Le, Gia Han 組織名 Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.;Department of Pharmacology and Toxicology, University of Toronto, Toronto,;Ontario, Canada.;Brain and Cognition Discovery Foundation, Toronto, Ontario, Canada.;Mood Disorder Psychopharmacology Unit, University Health Network, Toronto,;Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.;Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.;Department of Public Health Sciences, University of Connecticut School of;Medicine, Farmington, CT, USA.;Department of Psychological Medicine, Yong Loo Lin School of Medicine, Medicine,;Singapore.;Institute for Health Innovation and Technology (iHealthtech), National University;of Singapore, Singapore, Singapore.;Key Laboratory of Cognition and Personality, Faculty of Psychology, Ministry of;Education, Southwest University, Chongqing, P. R. China.;Institute of Medical Science, University of Toronto, Toronto, Ontario, Canada. Pubmed リンク https://www.ncbi.nlm.nih.gov/pubmed/38804896/ -
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