{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T06:05:03Z","timestamp":1789538703065,"version":"build-2803163510"},"reference-count":35,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T00:00:00Z","timestamp":1789516800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Psychiatry"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Zopiclone is widely prescribed for insomnia, but the pharmacovigilance reporting signals for hallucinations remain poorly characterized. This study combines a case report and pharmacovigilance data to evaluate the association between zopiclone and hallucinations, compare hallucination subtype signals, and examine factors associated with higher reporting odds.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We reported a clinical case assessed by the Naranjo scale and analyzed the Canadian Vigilance Adverse Reaction Database (1994-2025) for zopiclone-associated hallucinations. Three disproportionality methods (ROR, PRR, and BCPNN-IC) were used for signal detection. Univariate and multivariate logistic regression were applied to identify factors associated with higher reporting odds.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In the presented case, auditory hallucinations worsened following zopiclone initiation and improved after discontinuation, with a Naranjo score of 4, suggesting a possible temporal association. A total of 58 valid cases of zopiclone-associated hallucinations were included in the database, accounting for 2.41% of all zopiclone-associated adverse events. 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 \u2265 65 years was independently associated with higher reporting odds of zopiclone-associated hallucinations (adjusted OR = 2.48, 95% CI: 1.42-4.30, P &amp;lt; 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Zopiclone is associated with a reporting signal for hallucinations, with auditory hallucinations showing a numerically higher point estimate in this dataset. Age \u2265 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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fpsyt.2026.1925410","type":"journal-article","created":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T05:33:08Z","timestamp":1789536788000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Zopiclone-associated hallucinations: a case report and database pharmacovigilance study"],"prefix":"10.3389","volume":"17","author":[{"given":"Pan","family":"Zhang","sequence":"first","affiliation":[{"name":"Pharmacy Department, Chongqing Mental Health Center","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruihan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Branch fourteen Team Four, College of Basic Medical Science, Army Medical University (Third Military Medical University)","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuxuan","family":"Gao","sequence":"additional","affiliation":[{"name":"Branch fourteen Team Four, College of Basic Medical Science, Army Medical University (Third Military Medical University)","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunxiang","family":"Wei","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Chongqing Mental Health Center","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qian","family":"Zhao","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Chongqing Mental Health Center","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qunfang","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, College of Pharmacy and Laboratory Medicine, Army Medical University (Third Military Medical University)","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junlin","family":"Diao","sequence":"additional","affiliation":[{"name":"Pharmacy Department, Chongqing Mental Health Center","place":["Chongqing, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,9,16]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(22)00878-9","article-title":"Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis","volume":"400","author":"De Crescenzo","year":"2022","journal-title":"Lancet"},{"key":"B2","first-page":"45","article-title":"The night and day challenge of sleep disorders and insomnia: a narrative review","volume":"52","author":"Mombelli","year":"2024","journal-title":"Actas Espa\u00f1olas Psiquiatr\u00eda"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.18773\/austprescr.2008.084","article-title":"Hypnotic hazards: adverse effects of zolpidem and other z-drugs","volume":"31","author":"Olson","year":"2008","journal-title":"Aust Prescriber"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2025.1592065","article-title":"Dependence on zopiclone: a case report","volume":"16","author":"Guo","year":"2025","journal-title":"Front Psychiatry"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.7150\/ijms.51658","article-title":"Differences in detected safety signals between benzodiazepines and non-benzodiazepine hypnotics: pharmacovigilance study using a spontaneous reporting system","volume":"18","author":"Toyoshima","year":"2021","journal-title":"Int J Med Sci"},{"key":"B6","first-page":"32","article-title":"Zopiclone \u2013 indicated for short-term use only","volume":"40","author":"Medsafe New Zealand","year":"2019","journal-title":"Prescriber Update"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0340357","article-title":"Suicide adverse events associated with zopiclone and eszopiclone: a pharmacovigilance analysis based on FAERS, JADER and CVARD","volume":"21","author":"Xu","year":"2026","journal-title":"PloS One"},{"key":"B8","article-title":"Canada vigilance adverse reaction online database - 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