The Real-World Safety Profile of Temazepam: A 20-Year Pharmacovigilance Analysis Based on the Large-Scale FAERS Database.

OBJECTIVE

Temazepam has not been adequately investigated for its long-term safety profile in broad patient populations. This study aimed to characterize temazepam's real-world long-term safety profile.

METHODS

Reports of adverse events from Q1 2006 to Q4 2025 comprising temazepam were collected from the FAERS database. Data were analyzed using disproportionality methods including the proportional reporting ratio (PRR), the reporting odds ratio (ROR), the multi-item gamma poisson shrinker (MGPS), and the Bayesian confidence propagation neural network (BCPNN).

RESULTS

A total of 2788 adverse event reports associated with temazepam were retrieved. The most frequently reported events were drug ineffective, eye irritation, and toxicity to various agents. We also detected numerous ocular risk signals absent from the product label, together with potential abuse signals. Furthermore, our study identified several behavioral risk signals such as abnormal behavior, aggression, and amnesia and parasomnias-related adverse events like nightmare and somnambulism.

CONCLUSIONS

A comprehensive analysis of the large scale real world FAERS database was performed in this study identifying an extensive spectrum of adverse events associated with temazepam. Our study confirmed established risks and detected potential novel signals including ocular toxicities (e.g., eye irritation, intraocular pressure increased, glaucoma, eye inflammation, and photophobia) as well as neuro behavioral adverse outcomes such as aggression, amnesia and parasomnias (e.g., nightmare and somnambulism). These findings provide compelling support for temazepam clinical monitoring and risk assessment.