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Eszopiclone

Eszopiclone is a prescription sleep medicine (a sedative-hypnotic) used to treat insomnia, and it comes as Lunesta and as generic eszopiclone tablets.

Brand name Lunesta
Rx Schedule CIV Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 71 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record
Eszopiclone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Eszopiclone (Lunesta) is a prescription medicine for insomnia that quiets brain activity, likely by acting near the same calming receptors benzodiazepines use; it is one of the familiar “Z-drug” sleep medicines, on the market since about 2004 and available generically. Most people tolerate it reasonably well, and what they notice most is an unpleasant taste in the mouth and some next-morning grogginess. Its boxed warning is complex sleep behaviors (sleep-walking, sleep-driving and other activities while not fully awake), which can cause serious injury or death, so stop it immediately if one happens. Take it only at bedtime with a full 7 to 8 hours ahead, skip alcohol, and use the lowest dose that works.

Clinical pearls

  • Avoid taking it with or right after a heavy, high-fat meal, which slows absorption and blunts its effect.
  • Tell any prescriber adding clarithromycin, ketoconazole, itraconazole or ritonavir, since these raise eszopiclone levels and call for a lower dose.
  • Never combine it with another sleep medicine, and expect stronger sedation alongside opioids, benzodiazepines or olanzapine.
  • After regular nightly use, plan a gradual taper with your prescriber rather than stopping suddenly, which can cause withdrawal.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Eszopiclone can cause complex sleep behaviors, such as sleep-walking or sleep-driving, which can lead to serious injury or death. You may do things like these while not fully awake, and you usually will not remember them.

These events can happen after the first dose or any later dose. They have occurred with eszopiclone alone at recommended doses, with or without alcohol or other sedating drugs. If this happens to you, stop eszopiclone immediately and contact your doctor.

Eszopiclone is also a controlled substance (C-IV) that can be abused or lead to dependence. Keep it in a safe place, and never sell or give it away.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record2004
Companies listing it with the FDA26
FDA label last updatedJan 8, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Eszopiclone, written from its FDA label.

What Eszopiclone is used for

▾

Eszopiclone is used for one condition.

  • Insomnia: Lunesta and eszopiclone tablets are approved to treat it, helping people fall asleep faster and stay asleep.

How Eszopiclone works

▾

Eszopiclone is a sedative-hypnotic, a medicine that promotes sleep. Exactly how it works is unclear. It may interact with GABA receptor complexes in the brain, near where benzodiazepine medicines act.

Eszopiclone dosage

▾

Eszopiclone is taken by mouth as a tablet, once a night, immediately before bed. You should have 7 to 8 hours left before you need to wake up.

  • Do not take it with or right after a heavy, high-fat meal. It may take longer to work.
  • Your prescriber will start with a low dose and use the lowest dose that works.
  • Older adults, people with severe liver disease, and people taking strong CYP3A4 inhibitors have a lower maximum dose.
  • Follow your prescriber and the label for dosing and for what to do if you miss a dose.

Dosing details from the FDA-approved label

From the Eszopiclone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adults
    • Recommended starting dose is 1 mg, once daily immediately before bedtime, with at least 7-8 hours remaining before the planned time of awakening
    • Dosing can be raised to 2 mg or 3 mg if clinically indicated
    • Maximum: 3 mg once daily
    • Do not take with or immediately after a heavy, high-fat meal; this slows absorption and is expected to reduce the effect on sleep latency.
  • Geriatric or debilitated patients
    • The total dose should not exceed 2 mg in elderly or debilitated patients
    • Maximum: 2 mg
  • Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors
    • The total dose should not exceed 2 mg
    • Maximum: 2 mg
Read the label’s full dosing text

2 DOSAGE & ADMINISTRATION Use the lowest effective dose for the patient. • Use the lowest dose effective for the patient ( ) • Recommended initial dose is 1 mg, immediately before bedtime, with at least 7 to 8 hours remaining before the planned time of awakening. May increase dose if clinically indicated, to a maximum of 3 mg ( Error! Hyperlink reference not valid. ) • Geriatric or debilitated patients: Dose should not exceed 2 mg ( Error! Hyperlink reference not valid. ) • Patients with severe hepatic impairment, or taking potent CYP3A4 inhibitors: Dose should not exceed 2 mg ( Error! Hyperlink reference not valid. ) • Do not take with or immediately after a meal ( Error! Hyperlink reference not valid. ) 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 eszopiclone tablets 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 Error! Hyperlink reference not valid. ]. The total dose of eszopiclone tablets should not exceed 3 mg, once daily immediately before bedtime [ see Error! Hyperlink reference not valid. ]. 2.2 Geriatric or Debilitated Patients The total dose of eszopiclone tablets 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 eszopiclone tablets with potent CYP3A4 inhibitors, the total dose of eszopiclone tablets should not exceed 2 mg [ see Error! Hyperlink reference not valid. ]. 2.4 Use with CNS Depressants Dosage adjustments may be necessary when eszopiclone tablets are combined with othercentral nervous system (CNS) depressant drugs because of the potentially additive effects [ see Error! Hyperlink reference not valid. ]. 2.5 Administration with Food Taking eszopiclone tablets with or immediately after a heavy, high-fat meal results in slower absorption and would be expected to reduce the effect of eszopiclone tablets on sleep latency [see Error! Hyperlink reference not valid. ].

Read the full Dosage and Administration section on DailyMed →

Eszopiclone side effects

▾

The most common side effects in studies were:

Common side effects

  • Unpleasant taste in the mouth
  • Headache
  • Sleepiness (somnolence)
  • Dizziness
  • Dry mouth
  • Respiratory (breathing-passage) infection
  • Rash
  • Anxiety

When to get medical help

  • Sleep-walking, sleep-driving, or other activities while not fully awake (such as cooking, eating, phone calls, or sex). Stop eszopiclone and call your doctor right away.
  • Swelling of the tongue, throat, or voice box, trouble breathing, or throat closing. Get emergency help and do not take it again.
  • New or worrying changes in thinking or behavior, such as hallucinations, agitation, bizarre behavior, or acting out of character.
  • Worsening depression or thoughts of suicide.
  • Insomnia that does not improve after 7 to 10 days, or gets worse.
  • Withdrawal symptoms after stopping suddenly or cutting the dose quickly.
  • Next-day drowsiness or impaired alertness, especially while driving.

Get help right away for sleep-walking or sleep-driving, signs of a severe allergic reaction (swelling of the tongue or throat, trouble breathing), serious behavior changes, or worsening depression or suicidal thoughts.

Eszopiclone warnings and precautions

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  • Complex sleep behaviors (boxed warning): sleep-walking, sleep-driving, and other activities while not fully awake can cause serious injury or death. Stop eszopiclone right away if this happens.
  • Next-day impairment: can affect driving and alertness the next day, even if you feel fine. Patients using the highest dose should be cautioned against driving or other hazardous activities the next day.
  • Abnormal thinking and behavior: including hallucinations, agitation, and memory loss. Worsening depression and suicidal thoughts have occurred with sedative-hypnotics.
  • Serious allergic reactions: rare angioedema and anaphylaxis. Do not take it again if this happens.
  • Withdrawal: symptoms may occur after stopping abruptly or lowering the dose quickly.
  • Dependence: it is a C-IV controlled substance.
  • If insomnia does not improve after 7 to 10 days, it needs to be re-evaluated.

Eszopiclone interactions

▾

Eszopiclone can interact with sedating substances and with drugs that change how it is broken down.

  • Alcohol: adds to sleepiness and impaired coordination.
  • Other CNS depressants (benzodiazepines, opioids, tricyclic antidepressants): additive effects, so doses may need lowering.
  • Other sleep medicines at bedtime or during the night: not recommended.
  • Ketoconazole and other strong CYP3A4 inhibitors: raise eszopiclone levels, so a lower dose is needed.
  • Rifampicin: may reduce eszopiclone levels and effect.
  • Olanzapine: can add to effects on psychomotor performance.

Interactions listed in the FDA-approved label

From the Eszopiclone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • CNS depressants: Additive CNS-depressant effects with combination use. Dosage adjustments may be necessary when combined with other CNS depressant drugs.
  • Ethanol: An additive effect on psychomotor performance was seen with coadministration of eszopiclone and ethanol.
  • Olanzapine: Coadministration produced a decrease in DSST scores; the interaction was pharmacodynamic with no alteration in the pharmacokinetics of either drug.
  • Ketoconazole and other potent CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir): Ketoconazole, a potent CYP3A4 inhibitor, increased eszopiclone exposure (2.2-fold); other strong CYP3A4 inhibitors would be expected to behave similarly. Dose reduction of eszopiclone is needed; total dose should not exceed 2 mg.
  • Rifampicin (CYP3A4 inducers): Racemic zopiclone exposure was decreased 80% by rifampicin, and a similar effect would be expected with eszopiclone; combination use with a CYP3A4 inducer may decrease the exposure and effects of eszopiclone.
  • Paroxetine: Coadministration of a single dose produced no pharmacokinetic or pharmacodynamic interaction; this does not predict the complete absence of a pharmacodynamic effect following chronic administration.
  • Lorazepam: Coadministration of single doses did not have clinically relevant effects on the pharmacodynamics or pharmacokinetics of either drug; Cmax of each decreased by 22%.
Read the label’s full interactions text

7 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 eszopiclone ( 7.2 ) • Ketoconazole: Combination use increases exposure and effect of eszopiclone. Dose reduction of eszopiclone 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 eszopiclone is needed for patients co administered eszopiclone 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 eszopiclone.

Drug Interactions Eszopiclone is metabolized by CYP3A4 and CYP2E1 via demethylation and oxidation. There were no pharmacokinetic or pharmacodynamic interactions between eszopiclone and paroxetine.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿195 supplements and herbs with documented Eszopiclone interactions, ranked by severity Check Eszopiclone against a supplement or herb →

Before taking Eszopiclone

▾
  • Do not use if you have had complex sleep behaviors on eszopiclone or are allergic to it.
  • Tell your doctor about any history of drug or alcohol misuse or dependence.
  • Tell your doctor if you have depression or suicidal thoughts.
  • Older or debilitated adults need a lower dose and are at higher risk of falls.
  • Severe liver impairment calls for a lower dose; use caution with any liver impairment. Kidney impairment does not require a dose change.
  • Use caution with breathing problems.
  • Not established as safe or effective in children.
  • Pregnancy: human data are insufficient to identify a risk. Breastfeeding: no data on milk or the infant. Discuss with your prescriber.

Eszopiclone overdose

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Overdose can cause sleepiness that ranges up to coma. Deaths have been reported only when eszopiclone was combined with other CNS depressants or alcohol. Seek emergency care or contact poison control right away; treatment is supportive, with monitoring of breathing, pulse, and blood pressure.

How your body processes Eszopiclone

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Eszopiclone is absorbed quickly and peaks in about 1 hour. Its half-life is about 6 hours, or about 9 hours in adults 65 and older. It is broken down mainly by the liver enzymes CYP3A4 and CYP2E1, and less than 10% leaves in the urine unchanged. A high-fat meal can slow its onset.

How to store Eszopiclone

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Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

195

Supplements & herbs that interact with Eszopiclone

195 supplements and herbal products have documented interactions with Eszopiclone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 9
  • Moderate · 147
  • Minor · 39
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major GRAPEFRUIT Major KAVA Major L-TRYPTOPHAN Major ST. JOHN'S WORT Major +187 more
Every supplement checked against Eszopiclone — ranked by severity The full interaction hub: 9 major · 147 moderate · 39 minor · every one linked to its full report. Check Eszopiclone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Eszopiclone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Eszopiclone — the kind of thing our pharmacy team would talk through with you at the counter.

What is eszopiclone for?

▾
It treats insomnia. In studies it helped people fall asleep faster and stay asleep. It is meant to be taken right at bedtime.

How should I take it?

▾
Take it by mouth right before bed, when you can get a full 7 to 8 hours of sleep. Avoid taking it with or right after a heavy, high-fat meal, since that can slow it down. Follow your prescriber’s directions on dose.

What side effects should I expect?

▾
The most common are an unpleasant taste in your mouth, headache, sleepiness, dizziness, and dry mouth. Some people feel drowsy the next day, so be careful driving until you know how it affects you.

What should make me call you or my doctor right away?

▾
If you sleep-walk, sleep-drive, or do things like eat or make calls while not fully awake, stop it and call your doctor. Also get help right away for swelling of the tongue or throat, trouble breathing, hallucinations, unusual behavior changes, or worsening mood or suicidal thoughts.

Can I have a drink with it?

▾
It’s best not to. Alcohol adds to the sedation and can raise the risk of complex sleep behaviors and next-day impairment. Tell me about any other sedating medicines or antifungals like ketoconazole too.

Is it safe in pregnancy or for older adults?

▾
There isn’t enough human data to know the risk in pregnancy, so talk with your prescriber. Older adults should use a lower dose and take extra care to avoid falls.

Is Eszopiclone available over the counter?

▾
No. Eszopiclone is a prescription medicine: every Eszopiclone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Eszopiclone a controlled substance?

▾
Yes — Eszopiclone is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Eszopiclone first available?

▾
The earliest FDA record we hold for Eszopiclone is from 2004: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Eszopiclone was first used.

Who makes Eszopiclone?

▾
26 companies currently list Eszopiclone products in the FDA's NDC Directory, including Proficient Rx LP, Advanced Rx of Tennessee, LLC, Bryant Ranch Prepack. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Eszopiclone on HelloPharmacist

📊Eszopiclone supplement interactions195 checked — ranked by severity 🌿Drug & Supplement CheckerEszopiclone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Eszopiclone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Eszopiclone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Eszopiclone forms and strengths (how it comes)

Eszopiclone is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth · Oropharyngeal
Brands Lunesta
How this form is used
What it may be used for
  • Lunesta tablets are used to treat insomnia.
  • Eszopiclone tablets are used to treat insomnia.
Important instructions
  • Lunesta is taken once daily right before bedtime, with at least 7 to 8 hours left for sleep.
  • Eszopiclone tablets are taken right before bedtime and not with or right after a heavy, high-fat meal.
  • Lunesta and eszopiclone tablets have maximum doses that are lower for older or debilitated patients, those with severe liver impairment, and those taking strong CYP3A4 inhibitors.
Available strengths 3 strengths
1 mg 2 mg 3 mg
182 FDA-listed product records ⓘ

Eszopiclone on the U.S. market: products, makers and brands

How Eszopiclone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

26 companies list 93 Eszopiclone product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2004. Brand names on the directory include Lunesta; the rest are generics.

1
Dose forms ⓘ
26
Labelers (makers, repackagers, distributors)
2
Brand names
93
FDA-listed product records ⓘ
2004
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (12) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Proficient Rx LP11%
Advanced Rx of Tennessee, LLC9%
Bryant Ranch Prepack9%
Asclemed USA, Inc.6%
Preferred Pharmaceuticals Inc.5%
A-S Medication Solutions4%
Other makers56%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Eszopiclone is used (Medicaid data)

A general measure of how commonly Eszopiclone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Eszopiclone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

227,706
Medicaid prescriptions filled (Q1–Q4 2025)
$2.7M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Eszopiclone prescribed? Of the 1,601 medications we measure, Eszopiclone ranks #375 by Medicaid prescriptions — more than 77% of them.

Where Eszopiclone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #375 of 1,601
#370 Heparin 233,533 Rx #371 Bacitracin Topical 231,283 Rx #372 Cefazolin Injection 230,732 Rx #373 Cefazolin 230,732 Rx #374 Thyroid 228,962 Rx #375 Eszopiclone 227,706 Rx #376 Metronidazole Topical 224,112 Rx #377 Simethicone 219,250 Rx #378 Anastrozole 219,033 Rx #379 Permethrin Topical 217,112 Rx #380 Moxifloxacin Ophthalmi... 215,639 Rx

Utilization by Eszopiclone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 3 mg oral tablet is the most-dispensed Eszopiclone product — about 54% of these Medicaid prescriptions.

eszopiclone 3 MG Oral Tablet Most dispensed

122,266 Medicaid prescriptions (Q1–Q4 2025) 54% of Eszopiclone prescriptions shown $1.4M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 9 of 137 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485465

eszopiclone 2 MG Oral Tablet

65,842 Medicaid prescriptions (Q1–Q4 2025) 29% of Eszopiclone prescriptions shown $772,100 gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 8 of 139 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485442

eszopiclone 1 MG Oral Tablet

39,598 Medicaid prescriptions (Q1–Q4 2025) 17% of Eszopiclone prescriptions shown $526,030 gross reimbursement (before rebates) ≈ $13 per prescription (gross)

Summed across the 9 of 123 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 485440

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Eszopiclone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 26 of 399 listed Eszopiclone NDCs with Medicaid activity.

Compare Eszopiclone products

A representative set of FDA-listed product records for Eszopiclone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 93 of 93 products — FDA National Drug Code Directory. See every product, package size and price: browse all 93 Eszopiclone NDCs →

Eszopiclone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 2 Eszopiclone recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Jun 4, 2024 · Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications: Related Substances
  • Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30 Lots: Lot#: C2302598, Exp 2/29/2025 FDA record D-0581-2024 →
Class II Jun 16, 2022 · Terminated · Macleods Pharma Usa Inc
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
  • Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himacha… Lots: Lot #: BEK2009A Exp: 11/2023 FDA record D-1174-2022 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Eszopiclone RxCUI 461016 1 dose form · 3 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 485439 In current FDA listings
    Clinical drug / strength (SCD) 1 MG RxCUI 485440 2 MG RxCUI 485442 3 MG RxCUI 485465

Look up RxCUI 461016 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Eszopiclone costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 2 mg $0.091 per tablet NDC details & price history
Tablet, Film Coated · Oral 1 mg $0.099 per tablet NDC details & price history
Tablet, Film Coated · Oral 3 mg $0.088 per tablet NDC details & price history
Tablet, Coated · Oral 3 mg $0.088 per tablet NDC details & price history
Tablet, Coated · Oral 2 mg $0.091 per tablet NDC details & price history
Tablet, Coated · Oral 1 mg $0.099 per tablet NDC details & price history
Tablet, Film Coated 1 mg $0.099 per tablet NDC details & price history
Tablet, Film Coated 2 mg $0.091 per tablet NDC details & price history
Tablet, Film Coated 3 mg $0.088 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Eszopiclone brand names

Eszopiclone is sold under one brand name in the FDA directory — Lunesta. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Lunesta

Who makes Eszopiclone: manufacturers and labelers

26 companies list Eszopiclone products with the FDA. By number of product records, the largest are Proficient Rx LP, Advanced Rx of Tennessee, LLC, Bryant Ranch Prepack. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Proficient Rx LP 10 Advanced Rx of Tennessee, LLC 8 Bryant Ranch Prepack 8 Asclemed USA, Inc. 6 Preferred Pharmaceuticals Inc. 5 A-S Medication Solutions 4 Remedyrepack Inc. 4 Aurobindo Pharma Limited 3 Bionpharma Inc. 3 Camber Pharmaceuticals, Inc. 3 Dr. Reddy's Laboratories Limited 3 Glenmark Pharmaceuticals Inc. USA 3 Golden State Medical Supply, Inc. 3 Lupin Pharmaceuticals, Inc. 3 Macleods Pharmaceuticals Limited 3 Mylan Pharmaceuticals Inc. 3 Sun Pharmaceutical Industries, Inc. 3 Teva Pharmaceuticals USA, Inc. 3 Waylis Therapeutics LLC 3 Advanced Rx Pharmacy of Tennessee, LLC 2 Direct Rx 2 NuCare Pharmaceuticals,Inc. 2 PD-Rx Pharmaceuticals, Inc. 2 Quality Care Products LLC 2

…and 2 more on the FDA NDC directory.

Eszopiclone drug class (RxNorm)

Eszopiclone belongs to the Benzodiazepine related drugs class.

Drug family (ATC) Benzodiazepine related drugs

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Eszopiclone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 8, 2025
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Eszopiclone.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Eszopiclone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
71
Finished products in the current FDA directory
93
Companies listing them (makers, repackagers, distributors)
26
FDA labeler codes behind them ⓘ
29
Linked representative label ⓘ
Waylis Therapeutics LLC
Linked label effective
Jan 8, 2025
Composite sections available
25
Linked SPL Set ID
3821f4b7-a3c8-4920-ba80-18aa96532c09
Linked SPL Document ID
4a1b20fc-a41d-41dd-a557-fa9333bb5c3b
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Waylis Therapeutics LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →