Eszopiclone: Side Effects, Uses & Monitoring
1 INDICATIONS AND USAGE Eszopiclone tablet is indicated for the treatment of insomnia.
- Data source
- FDA labeling via NIH DailyMed (label b39dc64d…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Unpleasant taste | 34% |
| Headache | 21% |
| Somnolence | 10% |
| Infection | 10% |
| Dry mouth | 7% |
| Dizziness | 7% |
| Dyspepsia | 5% |
| Nausea | 5% |
| Nervousness | 5% |
| Pain | 5% |
| Depression | 4% |
| Rash | 4% |
| Diarrhea | 4% |
| Pruritus | 4% |
| Viral infection | 3% |
| Vomiting | 3% |
| Anxiety | 3% |
| Confusion | 3% |
| Hallucinations | 3% |
| Libido decreased | 3% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
1 INDICATIONS AND USAGE Eszopiclone tablet is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only).
Conditions associated with Eszopiclone in labeling
Frequently Asked Questions
What is Eszopiclone used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Eszopiclone?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Eszopiclone. Individual risk varies.
Does Eszopiclone require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Eszopiclone.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.