Abstract：
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■FDA批准的双重食欲素受体拮抗剂（DORAs）suvorexant的包装说明书，lemborexant和daridorexant指出，应该监测自杀风险。自杀是否归因于DORA仍然未知。我们旨在评估与向FDA不良事件报告系统（FAERS）报告的DORA相关的自杀性。
■以曲唑酮作为对照测定报告比值比(ROR)。当95％置信区间（CI）不包括1.0时，确定了显着的不成比例报告。我们使用信息组件(IC)来计算95%CI(IC025)的下限。当IC025≥0时，IC显著增高。
■苏沃雷生（0.025ROR），lemborexant(0.019ROR),与曲唑酮相比，达立多生（0.002ROR）与报告的自杀完成几率显着相关（p<0.05）。关于自杀意念，DORA的ROR没有显着增加，抑郁症自杀,自杀行为和自杀企图。使用IC025观察到每个DORA的所有自杀性参数之间的非显著关联。
■我们没有发现每个DORA的FAERS中捕获的任何自杀性参数之间存在显着关联。所有在药理学/非药理学上治疗失眠症的人都应进行任何自杀方面的出现/恶化评估。
■以曲唑酮作为对照测定报告比值比(ROR)。当95％置信区间（CI）不包括1.0时，确定了显着的不成比例报告。我们使用信息组件(IC)来计算95%CI(IC025)的下限。当IC025≥0时，IC显著增高。
■苏沃雷生（0.025ROR），lemborexant(0.019ROR),与曲唑酮相比，达立多生（0.002ROR）与报告的自杀完成几率显着相关（p<0.05）。关于自杀意念，DORA的ROR没有显着增加，抑郁症自杀,自杀行为和自杀企图。使用IC025观察到每个DORA的所有自杀性参数之间的非显著关联。
■我们没有发现每个DORA的FAERS中捕获的任何自杀性参数之间存在显着关联。所有在药理学/非药理学上治疗失眠症的人都应进行任何自杀方面的出现/恶化评估。
