Lunesta (eszopiclone) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Lunesta
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Eszopiclone
Also reported as: Lunesta Tablets

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From April 2005 to June 2026, FDA received 10,885 adverse event reports that name Lunesta. In these reports the drug is a suspect or interacting product.

In the same period, 10,621 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 45 reports in the 12 months to June 2026 and 64 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Lunesta is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 12 reports that name Lunesta.
In January to March 2026, FDA received 7.
In April to June 2025, FDA received 15.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 289 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 10,882 of the 10,885 reports (99.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 289 terms.

Reaction terms in the reports that name Lunesta, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 10,885 reports
Drug ineffectivethe medicine did not work as expected	3,859	35.5%
Dysgeusiaaltered taste	3,740	34.4%
Insomniadifficulty sleeping	3,129	28.7%
Middle insomnia	1,151	10.6%
Initial insomnia	813	7.5%
Somnolencedrowsiness	570	5.2%
Headachehead pain	434	4%
Nauseafeeling sick	346	3.2%
Dizzinesslight-headedness or unsteadiness	312	2.9%
Drug effect decreasedthe medicine had less effect	219	2%
Anxiety	204	1.9%
Paradoxical drug reaction	189	1.7%
Fatiguetiredness	186	1.7%
Depressionlow mood	167	1.5%
Amnesiamemory loss	156	1.4%
Feeling abnormalfeeling odd or not right	155	1.4%
Nightmarenightmares	153	1.4%
Vomitingbeing sick	138	1.3%
Dry mouth	134	1.2%
Hallucinationseeing or hearing things that are not there	128	1.2%
Abnormal dreamsunusual dreams	120	1.1%
Overdosea dose above the recommended amount	108	1%
Diarrhoealoose or frequent stools	100	0.9%
Falla fall	99	0.9%
Suicide attempta suicide attempt	95	0.9%
Confusional stateconfusion	94	0.9%
Dyspnoeashortness of breath	94	0.9%
Agitationrestlessness	92	0.8%
Nervousness	88	0.8%
Painpain, site not specified	85	0.8%
Hangover	83	0.8%
Malaisegeneral feeling of being unwell	82	0.8%
Tremorshaking	76	0.7%
Memory impairmentmemory problems	75	0.7%
Completed suicidedeath by suicide	74	0.7%
Rashskin rash	73	0.7%
Astheniaweakness or lack of energy	71	0.7%
Pruritusitching	70	0.6%
Abdominal pain upperupper stomach pain	67	0.6%
Suicidal ideationthoughts of suicide	65	0.6%
Hyperhidrosisexcessive sweating	64	0.6%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	63	0.6%
Intentional overdosea deliberate overdose	63	0.6%
Drug interactionan interaction between medicines	62	0.6%
Restlessness	61	0.6%
Chest pain	55	0.5%
Palpitationsawareness of the heartbeat	54	0.5%
Weight decreasedweight loss	54	0.5%
Sleep disordera sleep problem	53	0.5%
Loss of consciousnesspassing out	50	0.5%

Download all 289 terms of Lunesta (CSV)

The counts add to more than 10,885 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Eszopiclone with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Eszopiclone	Generic name	1,463
Lunesta (this page)	Brand name	10,885

Sum of the separately reported names: 12,348. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Lunesta, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	3	1	0	0	0	0	0	1	2
2005	3,883	83	8	5	36	2	0	39	3,800
2006	3,424	111	10	13	62	3	0	40	3,313
2007	1,813	115	17	18	51	5	1	42	1,698
2008	130	97	15	12	42	7	0	39	33
2009	99	79	18	9	33	1	0	31	20
2010	73	57	13	3	18	5	0	29	16
2011	60	41	4	6	16	0	0	19	19
2012	74	55	8	3	19	3	0	28	19
2013	68	43	5	4	11	3	1	26	25
2014	75	56	5	1	16	2	0	40	19
2015	87	61	14	2	20	3	0	32	26
2016	86	67	8	2	25	1	1	44	19
2017	127	62	5	5	28	3	2	52	65
2018	115	43	3	0	13	0	0	38	72
2019	165	53	9	1	20	2	0	43	112
2020	118	67	10	1	17	2	0	57	51
2021	82	48	11	2	11	1	0	43	34
2022	80	47	4	3	14	1	0	42	33
2023	126	29	1	1	13	1	0	18	97
2024	117	22	3	0	10	1	0	16	95
2025	59	37	11	4	16	5	1	25	22
2026	21	9	1	0	7	0	0	3	12

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Lunesta, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Lunesta, by the year in which FDA received them
Year	Reports
2005	2,293
2006	4,206
2007	2,605
2008	120
2009	96
2010	100
2011	65
2012	79
2013	73
2014	80
2015	81
2016	99
2017	131
2018	114
2019	156
2020	116
2021	79
2022	79
2023	126
2024	114
2025	54
2026	19

Reports that name Lunesta, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Lunesta
Age	Reports	Share
Under 2	7	0.1%
2 to 11	7	0.1%
12 to 17	22	0.2%
18 to 44	1,592	14.6%
45 to 64	3,357	30.8%
65 to 74	1,378	12.7%
75 and over	1,485	13.6%
Age not given	3,037	27.9%

Sex of the patient in the reports that name Lunesta
Sex	Reports	Share
Female	6,599	60.6%
Male	3,564	32.7%
Unknown or not given	722	6.6%

Type of reporter in the reports that name Lunesta
Reporter	Reports	Share
Physician	1,305	12%
Pharmacist	415	3.8%
Other health professional	586	5.4%
Lawyer	12	0.1%
Consumer or non-health professional	7,946	73%
Not given	621	5.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 95.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lunesta record
Indication as recorded (MedDRA)	Reports	Share
Insomnia	5,773	53%
Sleep disorder	229	2.1%
Initial insomnia	184	1.7%
Middle insomnia	67	0.6%
Sleep apnoea syndrome	31	0.3%
Fibromyalgia	16	0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 10,885 reports.

Drugs in the same reports

Other drugs that the reports of Lunesta name, in any role, in order of name
Drug	Reports that name the two
Ambien	959
Aspirin	319
Atenolol	227
Atorvastatin calcium	397
Lexapro	273
Lisinopril	219
Nexium	214
Simvastatin	239
Synthroid	343
Xanax	347

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Eszopiclone same ingredient
Lumryz next in the A to Z list
Lunsumio next in the A to Z list
Lumizyme next in the A to Z list
Lupaneta Pack next in the A to Z list
Lumigan 0 01% next in the A to Z list
Lupkynis next in the A to Z list
Lumigan next in the A to Z list
Lupron next in the A to Z list
Lumify next in the A to Z list
Lupron Depot next in the A to Z list
LumaSon next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for LunestaThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Lunesta: adverse event reports that FDA received. https://reportedreactions.com/drug/lunesta/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Lunesta as a suspect or interacting product. The 10,621 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Lunesta was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Lunesta?

No. It is a count of what people reported to FDA: 10,885 reports from April 2005 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (73%), physician (12%) and other health professional (5.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

To the top of the page