Quick answers
- What is Eszopiclone used for?
- The FDA-approved label (Lunesta, Waylis Therapeutics LLC, January 8, 2025) says: “LUNESTA ® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Eszopiclone have a boxed warning?
- Yes. The FDA label for Lunesta has a boxed warning (“WARNING: COMPLEX SLEEP BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Eszopiclone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Eszopiclone been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started June 4, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Eszopiclone?
- 27 companies list prescription products of Eszopiclone in the FDA NDC Directory, including Proficient Rx LP, Bryant Ranch Prepack and Advanced Rx of Tennessee, LLC.
What Eszopiclone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LUNESTA ® (eszopiclone) is indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, LUNESTA 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. …
— FDA label: Lunesta, Waylis Therapeutics LLC, effective January 8, 2025. Read the full label on DailyMed →
The FDA has 61 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: COMPLEX SLEEP BEHAVIORS
. Read it on the full label →
52 of 61 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated |
|---|---|
| Route | Oral · Oropharyngeal |
| Prescription products | 93 in the FDA NDC Directory |
| Brand names | Lunesta |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| eszopiclone 1 mg tablet, coated | Generic | $0.1066 per tablet |
| eszopiclone 1 mg tablet, film coated | Generic | $0.1066 per tablet |
| eszopiclone 2 mg tablet, coated | Generic | $0.0949 per tablet |
| eszopiclone 2 mg tablet, film coated | Generic | $0.0949 per tablet |
| eszopiclone 3 mg tablet, coated | Generic | $0.0910 per tablet |
| eszopiclone 3 mg tablet, film coated | Generic | $0.0910 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Proficient Rx LP10 products
- Bryant Ranch Prepack8 products
- Advanced Rx of Tennessee, LLC8 products
- Asclemed USA, Inc.6 products
- Preferred Pharmaceuticals Inc.5 products
- A-S Medication Solutions4 products
- Remedyrepack Inc.4 products
- Teva Pharmaceuticals USA, Inc.3 products
- Dr. Reddy's Laboratories Limited3 products
- Waylis Therapeutics LLC3 products
- Bionpharma Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Camber Pharmaceuticals, Inc.3 products
- Sun Pharmaceutical Industries, Inc.3 products
- Glenmark Pharmaceuticals Inc., USA3 products
- Aurobindo Pharma Limited3 products
- Lupin Pharmaceuticals, Inc.3 products
- Golden State Medical Supply, Inc.3 products
- Macleods Pharmaceuticals Limited3 products
- Direct_Rx2 products
- Quality Care Products, LLC2 products
- PD-Rx Pharmaceuticals, Inc.2 products
- Advanced Rx Pharmacy of Tennessee, LLC2 products
- Aphena Pharma Solutions - Tennessee, LLC1 product
- NuCarePharmaceuticals, Inc.1 product
- NuCare Pharmaceuticals, Inc.1 product
- St. Mary's Medical Park Pharmacy1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021476 LUNESTA | Waylis Therap | December 15, 2004 | 19, latest August 18, 2019 2019: Labeling · 2019: Labeling · 2018: Labeling |
Generic approvals (10)
- ANDA091169Teva · May 23, 2011
- ANDA091124Lupin Ltd · September 13, 2011
- ANDA091151Mylan Pharms Inc · March 26, 2013
- ANDA091103Sun Pharm · April 3, 2013
- ANDA091024DR Reddys · April 15, 2014
- ANDA091166Glenmark Pharms Ltd · April 15, 2014
- ANDA091113Orbion Pharms · June 10, 2014
- ANDA202929Macleods Pharms · January 30, 2015
- ANDA208451Aurobindo Pharma · September 15, 2016
- ANDA205504Hetero Labs Ltd V · January 4, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
June 4, 2024 · Class III · Ongoing · D-0581-2024
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 — Dr. Reddy's Laboratories, Inc.
-
June 16, 2022 · Class II · Terminated · D-1174-2022
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, Himachal Pradesh, INDIA, NDC — Macleods Pharma Usa Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lunesta, Waylis Therapeutics LLC, effective January 8, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →