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 →
NADAC price trail: ESZOPICLONE 1 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -16.6% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.1454/EA | - | 1 |
| December 18, 2024 | $0.1212/EA | -16.6% | 11 |
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.
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
- Insomnia
Insomnia
3,888 reports
- Dysgeusia
Dysgeusia
3,854 reports
- Nausea 1,382
Nausea
1,382 reports
- Middle Insomnia 1,213
Middle Insomnia
1,213 reports
- Fatigue 1,185
Fatigue
1,185 reports
- Headache 1,168
Headache
1,168 reports
- Somnolence 881
Somnolence
881 reports
- Dizziness 870
Dizziness
870 reports
- Initial Insomnia 856
Initial Insomnia
856 reports
- Anxiety 853
Anxiety
853 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) 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.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
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?
What pregnancy or breastfeeding source fields are listed for eszopiclone?
Is eszopiclone currently in shortage?
Related Medications in Non-Benzodiazepine Hypnotic (Z-Drug)
Other drugs grouped near eszopiclone - same-class peers and common alternatives.
lemborexant
Dayvigo
Dayvigo is a medicine that can help you fall asleep and stay asleep.
Compare with eszopiclone →
melatonin
Melatonin
Melatonin is a hormone supplement that can help with sleep.
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ramelteon
Rozerem
Ramelteon (Rozerem) is a prescription medicine that can help you fall asleep faster.
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suvorexant
Belsomra
Belsomra is a prescription medicine used to treat insomnia.
Compare with eszopiclone →
tasimelteon
Hetlioz
Tasimelteon (Hetlioz) is a medicine that helps people with Non-24-Hour Sleep-Wake Disorder (Non-24) sleep better.
Compare with eszopiclone →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for eszopiclone: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 24,883.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.63%.
- amoxicillin Δ 0.00 pts · 73,430 reports · Penicillin Antibiotic 6.63%death share
- dronedarone Δ 0.02 pts · 9,899 reports · Class III Antiarrhythmic 6.65%death share
- polyethylene glycol 3350 Δ 0.02 pts · 91,655 reports · Osmotic Laxative 6.65%death share
- ketoconazole Δ 0.02 pts · 16,231 reports · Azole Antifungal 6.65%death share
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
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on eszopiclone
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: February 20, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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