What the label lists and what reports show
Eszopiclone side effects
Eszopiclone's FDA label lists its adverse reactions in its own words. FAERS holds 25,313 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dysgeusia (3,854 reports).
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the eszopiclone FDA label on DailyMed (effective January 30, 2026, Glenmark Pharmaceuticals Inc. USA); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of eszopiclone tablets?Possible serious side effects of eszopiclone tablets include: • getting out of bed while not being fully awake and doing an activity that you do not know you are doing. (See “What is the most important information I should know about eszopiclone tablets?”) Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using eszopiclone tablets. The most common side effects of eszopiclone tablets are: • unpleasant taste in mouth, dry mouth These are not all the side effects of eszopiclone tablets. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Glenmark Pharmaceuticals Inc. USA, effective January 30, 2026 (SPL set 584dc66c-063a-4552-a056-74b811e2bc80), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following are described in more detail in the Warnings and Precautions section of the label: • Complex Sleep Behaviors [see Boxed Warning and Warnings and Precautions ( 5.1 )] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The premarketing development program for eszopiclone included eszopiclone exposures in patients and/or normal subjects from two different groups of studies: approximately 400 normal subjects in clinical pharmacology/pharmacokinetic studies, and approximately 1550 patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 263 patient-exposure years. …
Table 1: Incidence (%) of Adverse Reactions in a 6-Week Placebo-Controlled Study in Nonelderly Adults with Eszopiclone 1
This table is printed in the Eszopiclone label published by Lupin Pharmaceuticals, Inc. of January 17, 2024; the label quoted above does not print one.
| Adverse Reactions | Placebo (n=99) | Eszopiclone 2 mg (n=104) | Eszopiclone 3 mg (n=105) |
|---|---|---|---|
| Headache | 13 | 21 | 17 |
| Viral Infection | 1 | 3 | 3 |
| Dry Mouth | 3 | 5 | 7 |
| Dyspepsia | 4 | 4 | 5 |
| Nausea | 4 | 5 | 4 |
| Vomiting | 1 | 3 | 0 |
| Anxiety | 0 | 3 | 1 |
| Confusion | 0 | 0 | 3 |
| Depression | 0 | 4 | 1 |
| Dizziness | 4 | 5 | 7 |
| Hallucinations | 0 | 1 | 3 |
| Libido Decreased | 0 | 0 | 3 |
| Nervousness | 3 | 5 | 0 |
| Somnolence | 3 | 10 | 8 |
| Infection | 3 | 5 | 10 |
| Rash | 1 | 3 | 4 |
| Unpleasant Taste | 3 | 17 | 34 |
| Dysmenorrhea Gender-specific adverse reaction in females | 0 | 3 | 0 |
| Gynecomastia Gender-specific adverse reaction in males | 0 | 3 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Glenmark Pharmaceuticals Inc. USA, effective January 30, 2026 (SPL set 584dc66c-063a-4552-a056-74b811e2bc80), via openFDA; the full label on DailyMed
What do FAERS reports show?
25,313 reports list eszopiclone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,683 are coded as a death and 4,670 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Eszopiclone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions