ESZOPICLONE

N/A

Manufactured by Waylis Therapeutics LLC

47,350 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ESZOPICLONE

ESZOPICLONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Waylis Therapeutics LLC. The most commonly reported adverse reactions for ESZOPICLONE include DRUG INEFFECTIVE, INSOMNIA, DYSGEUSIA, NAUSEA, MIDDLE INSOMNIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ESZOPICLONE.

Top Adverse Reactions

DRUG INEFFECTIVE4,824 reports
INSOMNIA3,889 reports
DYSGEUSIA3,854 reports
NAUSEA1,383 reports
MIDDLE INSOMNIA1,213 reports
FATIGUE1,188 reports
HEADACHE1,171 reports
SOMNOLENCE881 reports
DIZZINESS871 reports
INITIAL INSOMNIA856 reports
ANXIETY853 reports
PAIN809 reports
DIARRHOEA744 reports
DEPRESSION713 reports
FALL654 reports
DYSPNOEA641 reports
VOMITING629 reports
COMPLETED SUICIDE523 reports
OFF LABEL USE519 reports
MALAISE511 reports
FEELING ABNORMAL501 reports
ARTHRALGIA465 reports
RASH464 reports
ASTHENIA457 reports
WEIGHT DECREASED422 reports
PRURITUS387 reports
PNEUMONIA383 reports
BACK PAIN377 reports
PYREXIA374 reports
TREMOR365 reports
WEIGHT INCREASED365 reports
CONSTIPATION362 reports
PAIN IN EXTREMITY354 reports
DEATH349 reports
DECREASED APPETITE342 reports
ABDOMINAL PAIN UPPER327 reports
MUSCLE SPASMS316 reports
CONDITION AGGRAVATED315 reports
CHEST PAIN314 reports
CHRONIC KIDNEY DISEASE305 reports
ABDOMINAL PAIN304 reports
DRUG EFFECT DECREASED302 reports
CONFUSIONAL STATE298 reports
OVERDOSE296 reports
COUGH291 reports
GAIT DISTURBANCE291 reports
HYPERHIDROSIS284 reports
MEMORY IMPAIRMENT284 reports
SUICIDAL IDEATION278 reports
HYPERTENSION272 reports
AMNESIA270 reports
URINARY TRACT INFECTION264 reports
MIGRAINE262 reports
RENAL FAILURE260 reports
HYPOAESTHESIA257 reports
TOXICITY TO VARIOUS AGENTS255 reports
HALLUCINATION253 reports
DRY MOUTH246 reports
DEHYDRATION242 reports
ACUTE KIDNEY INJURY237 reports
PARAESTHESIA236 reports
BLOOD PRESSURE INCREASED231 reports
SUICIDE ATTEMPT231 reports
NIGHTMARE229 reports
ANAEMIA228 reports
MYALGIA227 reports
PALPITATIONS226 reports
SINUSITIS223 reports
GASTROOESOPHAGEAL REFLUX DISEASE219 reports
AGITATION216 reports
HYPOTENSION216 reports
LOSS OF CONSCIOUSNESS208 reports
ABDOMINAL DISCOMFORT207 reports
ABNORMAL DREAMS202 reports
PRODUCT DOSE OMISSION ISSUE202 reports
ALOPECIA197 reports
CONTUSION197 reports
SLEEP DISORDER197 reports
OEDEMA PERIPHERAL196 reports
PARADOXICAL DRUG REACTION196 reports
VISION BLURRED191 reports
DRUG HYPERSENSITIVITY183 reports
INJECTION SITE PAIN180 reports
BALANCE DISORDER174 reports
DIABETES MELLITUS174 reports
HEART RATE INCREASED170 reports
INJURY170 reports
EMOTIONAL DISTRESS169 reports
DRUG INTERACTION168 reports
NASOPHARYNGITIS168 reports
NERVOUSNESS168 reports
URTICARIA165 reports
CHEST DISCOMFORT162 reports
MUSCULAR WEAKNESS161 reports
INCORRECT DOSE ADMINISTERED159 reports
DRUG DOSE OMISSION158 reports
DYSPEPSIA158 reports
HYPERSENSITIVITY158 reports
INTENTIONAL OVERDOSE158 reports
IRRITABILITY156 reports

Report Outcomes

Out of 24,880 classified reports for ESZOPICLONE:

Serious 39.7%Non-Serious 60.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female15,413 (65.3%)
Male8,046 (34.1%)
Unknown130 (0.6%)

Reports by Age

Age 58423 reports
Age 54413 reports
Age 56399 reports
Age 55396 reports
Age 60392 reports
Age 53388 reports
Age 50387 reports
Age 63386 reports
Age 64379 reports
Age 52377 reports
Age 57376 reports
Age 59376 reports
Age 48365 reports
Age 61362 reports
Age 65348 reports
Age 70342 reports
Age 51341 reports
Age 68338 reports
Age 47335 reports
Age 62334 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ESZOPICLONE?

This profile reflects 47,350 FDA FAERS reports that mention ESZOPICLONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ESZOPICLONE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, INSOMNIA, DYSGEUSIA, NAUSEA, MIDDLE INSOMNIA, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ESZOPICLONE?

Labeling and FAERS entries often list Waylis Therapeutics LLC in connection with ESZOPICLONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.