Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the united states food and drug administration adverse event reporting system (FAERS).

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

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 (

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.