LUNESTA FDA MedWatch Direct Reports Summary
These tables and charts are created from 570 voluntary U.S. reports for LUNESTA (ESZOPICLONE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS LUNESTA Report.
Top Adverse Effects Associated with LUNESTA (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 DRUG INEFFECTIVE 57 2 INSOMNIA 43 3 FATIGUE 41 4 HEADACHE 40 5 PRODUCT SUBSTITUTION ISSUE 39 6 NAUSEA 36 7 ANXIETY 28 8 PAIN 26 9 DIARRHEA 23 10 DIZZINESS 22 11 VOMITING 22 12 DEPRESSION 21 13 PALPITATIONS 21 14 FEELING ABNORMAL 20 15 DEATH 19 16 TREATMENT FAILURE 19 17 MUSCLE SPASMS 17 18 SHORTNESS OF BREATH 16 19 TREMOR 16 20 LACK OF STRENGTH AND ENERGY (ASTHENIA) 15 21 MIGRAINE 15 22 PINS AND NEEDLES 15 23 PRODUCT QUALITY ISSUE 15 24 JOINT PAIN 14 25 MALAISE 14
LUNESTA Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 157 | 366 | 47 | 570 |
| Medwatch Reporter Type | Count |
| Consumer | 262 |
| Physician | 22 |
| Pharmacist | 54 |
| Other Health Professional | 80 |
| Top Indications | |
| Insomnia | |
| Sleep disorder | |
| Depression | |
| Abnormal dreams | |
Type of Outcome Reported
Serious: 401
Not Serious: 169
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 570
Concomitant Drugs: 457
Note: A single MedWatch report can list more than one drug. This summary includes LUNESTA identified as the suspect drug or as a concomitantly taken drug.
FDA Safety-Related Labeling Changes
LUNESTA (ESZOPICLONE) Rx Drug:
FDA Safety-related Labeling Changes
Have experience (good or bad) with LUNESTA? Rate LUNESTA at Ask a Patient.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.