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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ZOPICLONE: 14,149 Adverse Event Reports & Safety Profile

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14,149
Total FAERS Reports
2,624 (18.5%)
Deaths Reported
7,438
Hospitalizations
14,149
As Primary/Secondary Suspect
1,598
Life-Threatening
323
Disabilities

First Report: 19660618 · Latest Report: 20250825

What Are the Most Common ZOPICLONE Side Effects?

#1 Most Reported
Toxicity to various agents
1,697 reports (12.0%)
#2 Most Reported
Coma
1,405 reports (9.9%)
#3 Most Reported
Drug ineffective
1,279 reports (9.0%)

All ZOPICLONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 1,697 12.0% 752 838
Coma 1,405 9.9% 68 984
Drug ineffective 1,279 9.0% 190 691
Somnolence 1,269 9.0% 60 1,012
Intentional overdose 1,247 8.8% 141 1,048
Off label use 1,243 8.8% 199 540
Headache 1,039 7.3% 183 400
Overdose 894 6.3% 296 352
Fatigue 830 5.9% 156 427
Drug interaction 750 5.3% 167 171
Fall 745 5.3% 92 541
Nausea 736 5.2% 132 364
Pain 729 5.2% 181 322
Depression 705 5.0% 201 286
Drug abuse 704 5.0% 266 206
Pyrexia 702 5.0% 150 367
Poisoning deliberate 672 4.8% 20 481
Dyspnoea 659 4.7% 81 413
Hypotension 657 4.6% 43 496
Suicide attempt 620 4.4% 31 491

Who Reports ZOPICLONE Side Effects? Age & Gender Data

Gender: 64.7% female, 35.3% male. Average age: 52.1 years. Most reports from: CA. View detailed demographics →

Is ZOPICLONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 15 0 15
2002 4 0 4
2003 6 0 5
2004 12 1 5
2005 17 0 1
2006 8 2 5
2007 13 1 9
2008 28 1 24
2009 28 4 16
2010 39 3 16
2011 50 3 38
2012 101 25 55
2013 123 27 58
2014 263 44 151
2015 348 50 251
2016 383 58 317
2017 722 115 424
2018 1,223 131 865
2019 933 105 618
2020 651 136 388
2021 599 112 328
2022 518 63 330
2023 516 72 283
2024 460 63 225
2025 184 26 96

View full timeline →

What Is ZOPICLONE Used For?

IndicationReports
Product used for unknown indication 7,533
Insomnia 1,968
Sleep disorder 652
Bipolar disorder 340
Migraine 242
Depression 233
Intentional overdose 223
Toxicity to various agents 186
Suicide attempt 166
Poisoning deliberate 128

ZOPICLONE vs Alternatives: Which Is Safer?

ZOPICLONE vs ZOTEPINE ZOPICLONE vs ZUCLOPENTHIXOL ZOPICLONE vs ZUCLOPENTHIXOL DECANOATE ZOPICLONE vs ZURANOLONE ZOPICLONE vs ZYPREXA ZOPICLONE vs ZYTIGA ZOPICLONE vs ZYVOX ZOPICLONE vs 5-FLUOROURACIL ZOPICLONE vs 5-FU ZOPICLONE vs 6-ACETYLMORPHINE

Official FDA Label for ZOPICLONE

Official prescribing information from the FDA-approved drug label.