35th AM (2024) - Poster Session-DORA Safety

DORA Safety

Pdf Summary

The safety analysis of the dual orexin receptor antagonists (DORAs) in comparison to other insomnia medications focused on assessing their abuse potential using data from the FDA Adverse Event Reporting System (FAERS). Chronic insomnia affects approximately 12% of U.S. adults, and while cognitive-behavioral therapy is preferred, various medications, including DORAs, are used for treatment. This study analyzed data from Jan 1, 2014, to Mar 31, 2024, to evaluate real-world abuse potential, contrasting DORAs with benzodiazepines, z-drugs, and other medications like trazodone.<br /><br />The analysis revealed significantly lower reports of abuse-related adverse events for DORAs compared to z-drugs, benzodiazepines, and trazodone. The case reports for abuse and safety risks associated with DORAs were substantially lower, indicating that these medications pose less abuse potential than many other insomnia treatments. For instance, DORAs had a 2.8% incidence of modified adverse SMQ terms, while benzodiazepines and z-drugs reported significantly higher percentages at 31.4% and 23.6%, respectively.<br /><br />The findings suggest that DORAs do not carry meaningful abuse risk, aligning with pre-clinical and clinical data showing no withdrawal symptoms or rebound insomnia. Limitations of the study include potential biases inherent in spontaneous reporting systems like duplicate reports and inaccuracies. Still, the collective post-marketing data affirm the safety profile of the DORA class.<br /><br />Overall, the study supports the notion that DORAs, which include suvorexant, lemborexant, and daridorexant, are safer regarding abuse potential compared to both scheduled and unscheduled alternative insomnia treatments, providing reassurance about their usage in clinical practice.

Keywords

dual orexin receptor antagonists

DORAs

insomnia medications

abuse potential

FDA Adverse Event Reporting System

FAERS

benzodiazepines

z-drugs

trazodone

safety analysis

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