Suicide adverse events associated with zopiclone and eszopiclone: A pharmacovigilance analysis based on FAERS, JADER and CVARD.

BACKGROUND: Suicide adverse events are a serious concern with zopiclone and eszopiclone. This study assessed the risk of such events by mining data from the FAERS, JADER, and CVARD databases. METHODS: The analysis included reports from Q1 2004 to Q4 2024 for FAERS, April 2004 to December 2024 for JADER, and January 1991 to December 2024 for CVARD. The risk was analyzed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), and Information Component (IC). RESULTS: A total of 361 reports of suicide adverse events linked to zopiclone and eszopiclone were included (FAERS: 120; JADER: 44; CVARD: 197). These events encompassed completed suicide, suicide attempt, suicidal ideation, suicidal behavior, self-injurious ideation, and intentional self-injury. Suicide attempt was consistently detected as a positive signal by all three methods across all databases and classified as a medium clinical priority.Multivariable logistic regression analysis from FAERS data indicated that males had an independently increased risk of suicide associated with these drugs [OR (95% CI): 14.70 (2.64-274.75), p = 0.012]. Most suicide-related events (60.0%) occurred within 0-180 days after taking medication. based on FAERS data. Survival analysis showed no significant gender difference in time to suicide onset (p = 0.15). The hazard rate remained constant over time (Weibull shape β = 0.80). Death was the outcome in 50.0% of cases following suicide onset. The average reported doses for zopiclone (262.5 mg) and eszopiclone (25.6 mg) significantly exceeded maximum recommended dosages. CONCLUSION: These findings align with published reports and clinical observations, highlighting the need for further clinical trials to investigate suicide associated with zopiclone and eszopiclone.