Comparative pharmacovigilance of non-benzodiazepine receptor agonists versus dual orexin receptor antagonists for insomnia in older adults - PubMed
6 hours ago
- #insomnia
- #pharmacovigilance
- #older adults
- Insomnia in older adults is a major public health challenge, with pharmacological treatments widely used despite safety concerns.
- A pharmacovigilance study using the FDA FAERS database compared non-benzodiazepine sedative-hypnotics (nBZRAs) and dual orexin receptor antagonists (DORAs) in patients aged 65+ from 2004 to 2025.
- nBZRAs, especially eszopiclone, showed strong signals for therapeutic failure (e.g., drug ineffective, insomnia) and dysgeusia.
- DORAs exhibited strong signals for dream-abnormality events, including nightmares, abnormal dreams, and hallucinations, aligning with their mechanism.
- No significant signal for falls was found for either drug class, with psychiatric and nervous system disorders having the highest incidence.