Supplementary file 1_Zopiclone-associated hallucinations: a case report and database pharmacovigilance study.docx

All three algorithms detected positive disproportionality signals for zopiclone-associated hallucinations, with auditory hallucinations showing a numerically higher point estimate (ROR = 4.71, 95% CI: 2.87-7.72), visual hallucinations (ROR = 3.49, 95% CI: 2.13-5.72), and hallucination (ROR = 2.39, 95% CI: 1.70-3.37). Multivariate logistic regression analysis showed that age ≥ 65 years was independently associated with higher reporting odds of zopiclone-associated hallucinations (adjusted OR = 2.48, 95% CI: 1.42-4.30, P < 0.01).

Sex was not independently associated with reporting odds of hallucinations, while BMI was not included in the multivariable model because of substantial missing data.</p>Conclusion<p>Zopiclone is associated with a reporting signal for hallucinations, with auditory hallucinations showing a numerically higher point estimate in this dataset. Age ≥ 65 years was independently associated with approximately 2.5-fold higher reporting odds of zopiclone-associated hallucinations.

Caution is warranted when prescribing zopiclone to elderly patients. These findings represent pharmacovigilance signals derived from spontaneous adverse-event reports and do not imply causality. The database contained only one schizophrenia case (n = 1); therefore, no subgroup-specific conclusion can be drawn.</p>