Analysis of sleep medication‐induced parasomnias using the Japanese Adverse Drug Event Report database

Summary The association between sleep medication and parasomnia remains unclear. However, some sleep medications may also cause parasomnia. Therefore, we examined the association between sleep medication use and parasomnia. We performed an analysis using cases registered in the Japanese Adverse Drug Event Report Database from April 2004 to March 2022. We calculated the unadjusted reporting odds ratio (ROR) and adjusted it to consider confounding factors. The ROR for each sleep medication was significant: benzodiazepines (ROR 3.55, 95% confidence interval [CI] 2.39–5.27), non‐benzodiazepines (ROR 14.21, 95% CI 10.41–19.39), melatonin receptor agonists (ROR 6.79, 95% CI 2.79–16.51), orexin receptor antagonists (ROR 18. 40, 95% CI 10.66–31.75). The adjusted RORs for non‐benzodiazepines (9.75, 95% CI 6.71–14.2) and orexin receptor antagonists (8.65, 95% CI 4.56–16.4) were significant for sleep medications. These findings indicate that non‐benzodiazepines and orexin receptor antagonists may cause parasomnias. Significant signals were detected, even when confounding factors were considered.