Eszopiclone: uses, dosing, side effects & brands
Eszopiclone is a medicine sold in the U.S. under one brand, for sleep initiation and maintenance disorders. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Sleep Initiation and Maintenance Disorders
- Available as
- Tablet
- Sold as
- Lunesta
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- What the pharmacy pays
- about $3 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
How eszopiclone is dosed
From the FDA label for Lunesta (application NDA021476). Other eszopiclone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Use the lowest effective dose for the patient. Use the lowest dose effective for the patient ( 2 ) Recommended initial dose is 1 mg, immediately before bedtime, with at least 7-8 hours remaining before the planned time of awakening. May increase dose if clinically indicated, to a maximum of 3 mg ( 2.1 ) Geriatric or debilitated patients: Dose should not exceed 2 mg ( 2.2 ) Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg ( 2.3 ) Do not take with or immediately after a meal ( 2.5 ) 2.1 Dosage in Adults The recommended starting dose is 1 mg. Dosing can be raised to 2 mg or 3 mg if clinically indicated. In some patients, the higher morning blood levels of LUNESTA following use of the 2 mg or 3 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [ see Warnings and Precautions ( 5.1 ) ]. The total dose of LUNESTA should not exceed 3 mg, once daily immediately before bedtime [ see Warnings and Precautions ( 5.6 ) ]. 2.2 Geriatric or Debilitated Patients The total dose of LUNESTA should not exceed 2 mg in elderly or debilitated patients. 2.3 Patients with Severe Hepatic Impairment, or Taking Potent CYP3A4 Inhibitors In patients with severe hepatic impairment, or in patients coadministered LUNESTA with potent CYP3A4 inhibitors, the total dose of LUNESTA should not exceed 2…
Eszopiclone side effects
The 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 )] CNS Depressant Effects and Next-Day Impairment [see Warnings and Precautions ( 5.2 )] Need to Evaluate for Comorbid Diagnoses [see Warnings and Precautions ( 5.3 )] Severe Anaphylactic and Anaphylactoid Reactions [see Warnings and Precautions ( 5.4 )] Abnormal Thinking and Behavioral Changes [see Warnings and Precautions ( 5.5 )] Withdrawal Effects [see Warnings and Precautions ( 5.6 )] Timing of Drug Administration [see Warnings and Precautions ( 5.7 )] Special Populations [see Warnings and Precautions ( 5.8 )] 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 LUNESTA 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. The conditions and duration of treatment with…
Who shouldn’t take eszopiclone
LUNESTA is contraindicated in patients who have experienced complex sleep behaviors after taking LUNESTA [see Warnings and Precautions ( 5.1 )]. LUNESTA is contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions ( 5.3 )] . Patients who have experienced complex sleep behaviors after taking LUNESTA ( 4 ) Known hypersensitivity to eszopiclone ( 4 )
Eszopiclone drug interactions
CNS Depressants: Additive CNS-depressant effects with combination use. Use with ethanol causes additive psychomotor impairment ( 7.1 ) Rifampicin: Combination use may decrease exposure and effects of LUNESTA ( 7.2 ) Ketoconazole: Combination use increases exposure and effect of LUNESTA. Dose reduction of LUNESTA is needed ( 7.2 ) 7.1 CNS Active Drugs Ethanol: An additive effect on psychomotor performance was seen with coadministration of eszopiclone and ethanol [see Warnings and Precautions ( 5.1 , 5.2 )] . Olanzapine: Coadministration of eszopiclone and olanzapine produced a decrease in DSST scores. The interaction was pharmacodynamic; there was no alteration in the pharmacokinetics of either drug. 7.2 Drugs that Inhibit or Induce CYP3A4 Drugs that Inhibit CYP3A4 (Ketoconazole) CYP3A4 is a major metabolic pathway for elimination of eszopiclone. The exposure of eszopiclone was increased by coadministration of ketoconazole, a potent inhibitor of CYP3A4. Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly. Dose reduction of LUNESTA is needed for patient co-administered LUNESTA with potent CYP3A4 inhibitors [see Dosage and Administration ( 2.3 )]. Drugs that Induce CYP3A4 (Rifampicin) Racemic zopiclone exposure was decreased 80% by concomitant use of rifampicin, a potent inducer of CYP3A4. A similar effect would be expected with eszopiclone. Combination use with CYP3A4 inducer may decrease the exposure and effects of LUNESTA.
Every eszopiclone product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Lunesta.
What eszopiclone pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Eszopiclone recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
How long eszopiclone keeps
No eszopiclone label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does eszopiclone expire? The in-use limits and storage rules from its labelsEszopiclone and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for eszopiclone: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo data are available on the use of eszopiclone during breastfeeding. Data from the racemate, zopiclone, indicate that occasional use while breastfeeding an older infant should pose little risk to the infant. A safety scoring system finds zopiclone possible to use during breastfeeding, but the infant should be monitored for sedation, poor feeding and poor weight gain. An alternate hypnotic may be preferred, especially while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised October 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about eszopiclone
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4,412 reports naming eszopiclone, and the FDA flagged 63% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue248 reports
- nausea245 reports
- insomnia241 reports
- diarrhoea171 reports
- anxiety168 reports
- headache168 reports
- fall134 reports
- dyspnoea123 reports
Read these as a signal, not a rate. A report does not mean eszopiclone caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is eszopiclone?
LUNESTA (eszopiclone) is a nonbenzodiazepine hypnotic agent that is a pyrrolopyrazine derivative of the cyclopyrrolone class.
Can you take eszopiclone with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run eszopiclone against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does eszopiclone come in?
Across the brands we track, eszopiclone is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic eszopiclone?
We do not currently list a generic-labelled eszopiclone product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has eszopiclone been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions eszopiclone. The most recent: Eszopiclone Tablets (Jun 4, 2024). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Eszopiclone: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/eszopiclone
- MLA
- “Eszopiclone: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/eszopiclone.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for eszopiclone on DailyMed (NIH) ↗ — including its boxed warning in full.