FDA Adverse Events Reports (FAERS) Summary for LUNESTA

These tables and charts are based on 21,452 total reports for LUNESTA (ESZOPICLONE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 20,882 pharmaceutical company-submitted and non-U.S. FAERS reports and 570 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 570 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch LUNESTA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with LUNESTA (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	4462
2	METALLIC OR ALTERED TASTE	3802
3	INSOMNIA	3748
4	NAUSEA	1219
5	MIDDLE INSOMNIA	1196
6	HEADACHE	1062
7	FATIGUE	997
8	INITIAL INSOMNIA	852
9	DROWSINESS	805
10	DIZZINESS	792
11	ANXIETY	741
12	PAIN	715
13	DEPRESSION	638
14	DIARRHEA	635
15	SHORTNESS OF BREATH	564
16	FALL	549
17	VOMITING	546
18	FEELING ABNORMAL	448
19	MALAISE	444
20	JOINT PAIN	421
21	OFF LABEL USE	398
22	LACK OF STRENGTH AND ENERGY (ASTHENIA)	386
23	RASH	376
24	WEIGHT DECREASED	371
25	ITCHING	341
26	BACK PAIN	338
27	WEIGHT INCREASED	331
28	FEVER	327
29	TREMOR	319
30	PAIN IN EXTREMITY	317
31	CONSTIPATION	311
32	PNEUMONIA	311
33	ABDOMINAL PAIN UPPER	296
34	CHEST PAIN	286
35	DRUG EFFECT DECREASED	286
36	DECREASED APPETITE	285
37	MUSCLE SPASMS	271
38	ABDOMINAL PAIN	262
39	GAIT DISTURBANCE	262
40	CONDITION AGGRAVATED	255
41	AMNESIA	254
42	COUGH	254
43	DEATH	254
44	EXCESS SWEATING	252
45	CHRONIC KIDNEY DISEASE	251
46	HIGH BLOOD PRESSURE	249
47	SUICIDAL IDEATION	249
48	CONFUSIONAL STATE	248
49	MEMORY IMPAIRMENT	248
50	NUMBNESS	241
51	URINARY TRACT INFECTION	232
52	DRY MOUTH	227
53	MIGRAINE	226
54	HALLUCINATION	223
55	OVERDOSE	217
56	NIGHTMARE	216
57	PINS AND NEEDLES	211
58	KIDNEY FAILURE	203
59	MUSCLE PAIN	202
60	DEHYDRATION	201
61	BLOOD PRESSURE INCREASED	200
62	PALPITATIONS	200
63	SINUSITIS	197
64	GASTROOESOPHAGEAL REFLUX DISEASE	195
65	PARADOXICAL DRUG REACTION	193
66	ABNORMAL DREAMS	191
67	ACUTE KIDNEY INJURY	189
68	AGITATION	188
69	ANEMIA	185
70	LOSS OF CONSCIOUSNESS	185
71	SUICIDE ATTEMPT	179
72	HAIR LOSS	175
73	SWELLING OF LIMBS	175
74	VISION BLURRED	173
75	ABDOMINAL DISCOMFORT	171
76	BRUISE	169
77	SLEEP DISORDER	166
78	NERVOUSNESS	161
79	DIABETES MELLITUS	160
80	INJURY	158
81	INJECTION SITE PAIN	155
82	EMOTIONAL DISTRESS	154
83	LOW BLOOD PRESSURE	154
84	PRODUCT DOSE OMISSION ISSUE	153
85	BALANCE DISORDER	152
86	DRUG HYPERSENSITIVITY	151
87	INDIGESTION	149
88	HEART RATE INCREASED	148
89	CHEST DISCOMFORT	144
90	MUSCULAR WEAKNESS	142
91	COMMON COLD	142
92	SKIN REDNESS	139
93	IRRITABILITY	139
94	INCORRECT DOSE ADMINISTERED	138
95	HIVES	138
96	DRUG DOSE OMISSION	137
97	SLEEP APNEA	136
98	BRONCHITIS	132
99	CHILLS	131
100	INFECTION	129

Latest Known Outcomes for Reactions Reported for LUNESTA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	5730
2	Patient has not recovered/symtoms have not resolved	2736
3	Patient recovered	2669
4	Patient is recovering/symptoms resolving	1406
5	Patient died	660
6	Patient has recovered but has consequent health issues	89

Search all MedWatch and FAERS by keyword:

LUNESTA Total Reports

Male	Female	Unknown	Total
6897	13409	1146	21,452

Top Countries Reporting

	Country	Number of Reports
1	United States	7513
2	Japan	1629
3	Canada	19
4	Puerto Rico	5
5	Germany	4
6	Denmark	3
7	China	2
8	Finland	1
9	Falkland Islands	1
10	France	1

Outcomes for Reports

Serious: 7679
Not Serious: 13772
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Insomnia
Sleep disorder
Depression
Abnormal dreams

Top Companies Reporting

WAYLIS THERAPEUTICS LLC

Safety-Related FDA Updates

FDA Approval Date: 2004-12-15

LUNESTA (ESZOPICLONE) Rx Drug:
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 the cases for LUNESTA reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. 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. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA 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 or comments about this report.