34th AM (2023) - Poster Session-Real World Evidence of Adverse Events

Real World Evidence of Adverse Events

Pdf Summary

A real-world evidence study was conducted to evaluate the adverse effects of Schedule IV approved insomnia medications, specifically focusing on those events that could indicate dependence or abuse. The study was funded by Idorsia Pharmaceuticals and presented at the AAAP 2023 Annual Meeting. The study utilized data from a US medical claims database and included patients who were prescribed benzodiazepines, Z-drugs, or dual orexin receptor antagonists (DORAs) for chronic insomnia disorder.<br /><br />The results showed that benzodiazepines and Z-drugs were associated with significant increases in adverse events that were likely to be connected to drug dependence or abuse potential. These included alcohol or drug abuse, dependence, depression, euphoria/dysphoria, mania, and mood changes. On the other hand, DORA medications showed no significant adverse events related to dependence or abuse potential.<br /><br />The study indicated that clinicians should be cautious when prescribing benzodiazepines and Z-drugs for chronic insomnia, as these medications have a higher risk of adverse events related to dependence or abuse. In contrast, DORA medications appear to have a lower risk profile in real-world use.<br /><br />The study had some limitations, including the use of claims data that relied on physician annotation of adverse events and a smaller dataset for DORA medications. Future analyses should include other medications approved for insomnia and commonly used off-label treatments.<br /><br />In conclusion, the study suggests that benzodiazepines and Z-drugs prescribed for insomnia have a higher likelihood of adverse events related to dependence or abuse potential, while DORA medications show a different safety profile in real-world use. Clinicians should consider the risks of drug dependence or abuse when treating patients with chronic insomnia. The study was funded by Idorsia Pharmaceuticals, and several authors have affiliations with the company.

Keywords

real-world evidence study

adverse effects

dependence

abuse

Idorsia Pharmaceuticals

benzodiazepines

Z-drugs

DORAs

chronic insomnia disorder

clinicians

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