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

Sep 30, 2026

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Suicide adverse events are a serious concern with zopiclone and eszopiclone. This study assessed risk by mining pharmacovigilance reports from FAERS, JADER, and CVARD databases. Reports spanning Q1 2004–Q4 2024 in FAERS, April 2004–December 2024 in JADER, and January 1991–December 2024 in CVARD were evaluated using reporting odds ratio, proportional reporting ratio, and Information Component methods. Across all databases, suicide attempt was a consistent positive signal. Multivariable logistic regression from FAERS indicated an independently increased risk in males, and most events occurred within 0–180 days.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages14

Reading Time35 min

AccessFree to download

Abstract

Background

Methods

Results

Introduction

Background on zopiclone and eszopiclone

Data availability and funding

Data availability statement

Funding

Conclusion

OPEN ACCESS Citation: Xu Y, Li F, Zhang M, Huang L (2026) Suicide adverse events associated with zopiclone and eszopiclone: A pharmacovigilance analysis based on FAERS, JADER and CVARD. PLoS One 21(1): e0340357. [https://doi.org/10.1371/journal](https://doi.org/10.1371/journal). pone.0340357 Editor: James M Wright, University of British Columbia, CANADA Received: July 13, 2025 Accepted: December 20, 2025 Published: January 8, 2026 Peer Review History: PLOS recognizes the benefits of transparency in the peer review process; therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. The editorial history of this article is available here: [https://doi.org/10.1371/journal](https://doi.org/10.1371/journal). pone.0340357 Copyright: © 2026 Xu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, RESEARCH ARTICLE Suicide adverse events associated with zopiclone and eszopiclone: A pharmacovigilance analysis based on FAERS, JADER and CVARD Yinpeng Xu1, Fang Li1, Mei Zhang2, Li Huang2* 1 Department of Pharmacy, Ninth People’s Hospital of Zhengzhou, Zhengzhou, Henan, China, 2 Department of Pharmacy, Women and Infants Hospital of Zhengzhou, Zhengzhou, Henan, China * [sunchenzhang@hhu.edu.cn](sunchenzhang@hhu.edu.cn) Abstract 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. PLOS One | [https://doi.org/10.1371/journal.pone.0340357](https://doi.org/10.1371/journal.pone.0340357) January 8, 2026 1 / 14 and reproduction in any medium, provided the original author and source are credited. Data availability statement: Raw datasets obtained from public sources were analyzed in this study.The raw data analysis from the three databases has a cutoff date of October 31, 2024. FAERS data can be found at: [https://](https://)[ ](https://)[fis.fda.gov/extensions/FPD-QDE-FAERS/FPD](fis.fda.gov/extensions/FPD-QDE-FAERS/FPD)QDE-FAERS. html; CVARD data can be found at: [https://www.canada.ca/en/health-canada/](https://www.canada.ca/en/health-canada/)[ ](https://www.canada.ca/en/health-canada/)[services/drugs-health-products/medeffect-can-](services/drugs-health-products/medeffect-can-)[ada/adverse-reaction-database/canada-vigi-](ada/adverse-reaction-database/canada-vigi-)[lance-online-database-data-extract.html](

FAQs

Which databases were used to evaluate suicide adverse events for zopiclone and eszopiclone?

The analysis mined FAERS, JADER, and CVARD databases for reported suicide-related events.

Which suicide-related outcome showed consistent detection across all three methods and databases?

Suicide attempt was consistently detected as a positive signal by all three methods across all databases.

What did the FAERS multivariable logistic regression suggest about sex differences?

FAERS multivariable logistic regression indicated that males had an independently increased risk of suicide associated with these drugs.

Sep 30, 2026

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