JPERM

Objective: Zolpidem is a non-benzodiazepine drug that is known for its relative safety benefit compared to traditional benzodiazepines. However, adverse events (AEs) on the central nervous system such as somnambulism, nightmares, and hallucinations have been consistently reported following its use. This study aimed to identify the AEs related to zolpidem in South Korea. To detect signals of AEs of zolpidem by data mining using the Korean Pharmaceutical Association adverse event reporting system (KPA) database. Methods: We evaluated KPA database from April 2013 to December 2021, a nationwide drug database reported from pharmacy, analyzing AEs reported for zolpidem. We compared the distribution of patient age and sex, frequent AEs, serious adverse events, and causality assessment were performed according to the KPA database system. To identify zolpidem-related AEs, we conducted disproportionality analysis. Estimating reporting odds ratio (ROR) with 95% confidence interval (CI) for each AE by using logistic regression. Results: A total of 155,771 AEs were reported in the KPA database, out of which 1,529 (0.01%) were related to zolpidem. The analysis revealed that dizziness (86 cases, 5.69%) and headache (72 cases, 4.76%) were the most frequently reported adverse events. Notably, somnambulism (ROR: 143.75, 95% CI, 109.17–189.28) was reported more frequently in association with zolpidem than with any other drugs. Additionally, 13 cases of serious AEs were reported. Conclusion: We identified 3 signals out of 5 most frequent AEs. It is necessary to monitor for these AEs related to zolpidem for appropriate and safe use.

KeywordsInsomnia, Zolpidem, Adverse events, Sleeping pill, Non-benzodiazepine drugs