Prescription medication · Non-Benzodiazepine Hypnotic (Z-Drug)
eszopiclone
Also sold as Lunesta. Eszopiclone is used to treat insomnia, which means you have trouble falling asleep or staying asleep.
Data updated 2026-05-15
- 24,883
- FDA reportsModerately reported
- 5
- InteractionsFew interactions
- 99% less
- Generic vs brandHuge savings
- In shortage
- FDA status
What the data shows
eszopiclone (Lunesta) is a prescription Non-Benzodiazepine Hypnotic (Z-Drug), reported at a middle-of-the-pack volume (24,883 FDA reports), whose generic costs a fraction of the brand (about 99% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
eszopiclone (Lunesta) is a prescription Non-Benzodiazepine Hypnotic (Z-Drug). Eszopiclone is used to treat insomnia, which means you have trouble falling asleep or staying asleep.
Eszopiclone (Lunesta) is a medicine that helps you fall asleep and stay asleep. It is used to treat insomnia.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
eszopiclone is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc..
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$23.07/unit
Generic Price
$0.12/unit
Generic Savings
99%
Generic Available
Yes (10 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Eszopiclone is used to treat insomnia, which means you have trouble falling asleep or staying asleep.
Common side effects
Unpleasant taste, Headache, Feeling sleepy
Key warnings
Eszopiclone can cause complex sleep behaviors like sleepwalking, sleep driving, and doing other activities while not fully awake.
The sections below are summarized in plain English from eszopiclone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Eszopiclone works by slowing down activity in your brain. This helps you relax and fall asleep. It affects certain chemicals in your brain that regulate sleep.
How to Take It
Take eszopiclone right before bed when you are ready to sleep. The usual starting dose is 1 mg. Your doctor may increase it to 2 mg or 3 mg if needed. Do not take it with or right after a meal.
This is a plain-language summary of eszopiclone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if eszopiclone can harm your unborn baby. Talk to your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
This is a plain-language summary of eszopiclone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you forget to take eszopiclone, skip that dose and take your next dose when you are ready to go to sleep. Do not take two doses at once.
This is a plain-language summary of eszopiclone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store eszopiclone at room temperature, between 68° to 77°F (20° to 25°C).
Side Effects (from patient reports)
Based on 24,883 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for eszopiclone, by number of reports
- Trouble sleeping
Trouble sleeping
3,890 reports
- Bad taste in mouth
Bad taste in mouth
3,853 reports
- Feeling sick to your stomach 1,383
Feeling sick to your stomach
1,383 reports
- Waking up in the middle of the night 1,213
Waking up in the middle of the night
1,213 reports
- Feeling tired 1,186
Feeling tired
1,186 reports
- Head pain 1,170
Head pain
1,170 reports
- Feeling sleepy 881
Feeling sleepy
881 reports
- Feeling lightheaded 872
Feeling lightheaded
872 reports
- Trouble falling asleep 856
Trouble falling asleep
856 reports
- Feeling worried or nervous 854
Feeling worried or nervous
854 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for eszopiclone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where eszopiclone sits
eszopiclone has more FDA adverse-event reports than 60% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is eszopiclone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 24,883 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2005–2025.
Total Reports
24,883
Reports Mentioning Death
1,650
6.6% of reports — not proof of cause
Hospitalization Reports
4,535
Top Indication
Insomnia
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | INSOMNIA | 3,888 |
| 3 | DYSGEUSIA | 3,854 |
| 4 | NAUSEA | 1,382 |
| 5 | MIDDLE INSOMNIA | 1,213 |
| 6 | FATIGUE | 1,185 |
| 7 | HEADACHE | 1,168 |
| 8 | SOMNOLENCE | 881 |
| 9 | DIZZINESS | 870 |
| 10 | INITIAL INSOMNIA | 856 |
| 11 | ANXIETY | 853 |
| 12 | PAIN | 808 |
| 13 | DIARRHOEA | 745 |
| 14 | DEPRESSION | 712 |
| 15 | FALL | 653 |
| 16 | DYSPNOEA | 641 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Eszopiclone can cause complex sleep behaviors like sleepwalking, sleep driving, and doing other activities while not fully awake. Some of these can lead to serious injuries or even death. Stop taking eszopiclone right away if this happens.
Known Drug Interactions
Use with ethanol causes additive psychomotor impairment ( 7.1 ) • Rifampicin Combination use may decrease exposure and effects of eszopiclone tablets ( 7.2 ) • Ketoconazole Combination use increases exposure and effect of eszopiclone tablets. 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.
Mechanism: Ketoconazole blocks the enzyme that breaks down the sleep medicine, causing it to stay in your body longer and work more strongly.
What to do: Your doctor may need to lower your dose of the sleep medicine to prevent you from feeling too sleepy or having other side effects.
Olanzapine: Coadministration of eszopiclone and olanzapine produced a decrease in DSST scores.
Mechanism: Taking these two drugs together can further slow down your thinking and coordination more than taking either one alone.
What to do: Be very careful when performing tasks that require focus, like driving, and tell your doctor if you feel overly drowsy or confused.
Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly.
Mechanism: Clarithromycin slows down how fast your body breaks down eszopiclone. This can cause the sleep medicine to stay in your system longer and increase its effects.
What to do: Your doctor may need to lower your dose of eszopiclone while you are taking this antibiotic.
Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly.
Mechanism: Itraconazole blocks the enzyme that clears eszopiclone from your body. This can lead to higher levels of the sleep medicine in your blood.
What to do: Talk to your doctor about adjusting your dose of eszopiclone to avoid excessive sleepiness.
Refer to the prescribing information for ivacaftor Eszopiclone (CYP3A4 Inhibition) Not Studied In Vivo or In Vitro , but Drug Plasma Exposure Likely to be Increased which may Increase the Sedative Effect of Eszopiclone Dose reduction of eszopiclone is recommended. Refer to the prescribing information for eszopiclone.
Mechanism: Voriconazole likely blocks the breakdown of eszopiclone, which can make the drug's effects much stronger. This may cause you to feel overly sleepy or sedated.
What to do: A lower dose of eszopiclone is recommended to avoid excessive sleepiness.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drive after taking eszopiclone?
Can I drink alcohol while taking eszopiclone?
What should I do if I still can't sleep after taking eszopiclone for a week?
Can I become addicted to eszopiclone?
What happens if I stop taking eszopiclone suddenly?
Can eszopiclone cause allergic reactions?
What dose should an elderly person take?
What if I have liver problems?
Can I take eszopiclone with other medicines?
What do the different colored pills mean?
What are the common side effects of eszopiclone?
Does eszopiclone interact with other medications?
What drug class is eszopiclone?
Is there a generic version of eszopiclone?
Is eszopiclone safe during pregnancy?
Is eszopiclone currently in shortage?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for eszopiclone
The FDA label for eszopiclone (sold under brand names such as Lunesta) classifies it as a prescription-only medication in the Non-Benzodiazepine Hypnotic (Z-Drug) class. Eszopiclone is used to treat insomnia, which means you have trouble falling asleep or staying asleep. Official labeling lists 10 commonly reported side effects, including Unpleasant taste, Headache, Feeling sleepy.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 24,883 voluntary reports. The database also lists 5 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.12 versus $23.07 for the brand - a 99% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: February 20, 2025
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages