Prescription medicine
Eszopiclone Brand names: Lunesta
Eszopiclone (Lunesta) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.0993 per eszopiclone 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the eszopiclone FDA label on DailyMed (effective January 30, 2026, Glenmark Pharmaceuticals Inc. USA); the NDA 21476 record on Drugs@FDA; every eszopiclone label on DailyMed.
Highlights of the record
FDA label of January 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
COMPLEX SLEEP BEHAVIORS.
Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of eszopiclone tablets. Some of these events may result in serious injuries, including death. Discontinue eszopiclone tablets immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning. Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of eszopiclone tablets. Some of these events may result in serious injuries, including death. Discontinue eszopiclone tablets immediately if a patient experiences a complex sleep behavior ( 4 , 5.1 ).
Used for
From the label: indications and usageEszopiclone tablets are indicated for the treatment of insomnia.
Forms and strengths
- 1 mg
- 2 mg
- 3 mg
Film-coated tablet; coated tablet.
On the market
- Earliest approval on file
- December 15, 2004 Lunesta, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 14 first May 23, 2011; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 27 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0993 per tablet Eszopiclone 1 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2013 0 Class I among all firms' recalls; latest June 4, 2024; 2 more by firms not listed as its makers
- FAERS reports
- 25,313 through July 30, 2026
What is eszopiclone used for?
From the label: indications and usageEszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets 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. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance ( 1 ).
Conditions named in the indications of eszopiclone's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Eszopiclone), Glenmark Pharmaceuticals Inc. USA, effective January 30, 2026 (SPL set 584dc66c-063a-4552-a056-74b811e2bc80), via openFDA; the full label on DailyMed
What does the patient leaflet for eszopiclone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about eszopiclone tablets?Do not take more eszopiclone tablets than prescribed. Eszopiclone tablets may cause serious side effects including: Complex sleep behaviors that have caused serious injury and death. After taking eszopiclone tablets, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with eszopiclone tablets whether or not you drink alcohol or take other medicines that make you sleepy. Reported activities and behaviors include: • doing activities when you are asleep like: Stop taking eszopiclone tablets and call your healthcare provider right away if you find out that you have done any of the above activities after taking eszopiclone tablets. The morning after you take eszopiclone tablets your ability to drive safely and think clearly may be decreased. You also may experience sleepiness during the day. Do not take eszopiclone tablets if you: • have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking eszopiclone tablets.
From the patient leaflet: How should I store eszopiclone tablets?Store eszopiclone tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°F to 30°C (59°F to 86°F) General Information about eszopiclone tablets • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about eszopiclone tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about eszopiclone tablets that is written for healthcare professionals. For more information, go to www.glenmarkpharma-us.com or call 1 (888) 721-7115.
Source: FDA drug label (Eszopiclone), Glenmark Pharmaceuticals Inc. USA, effective January 30, 2026 (SPL set 584dc66c-063a-4552-a056-74b811e2bc80), via openFDA; the full label on DailyMed
Is there a generic for eszopiclone (Lunesta)?
The FDA approved the first generic eszopiclone on May 23, 2011. 14 generic applications are approved; 9 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists eszopiclone from 27 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2011 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for eszopiclone (Lunesta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0993 per Eszopiclone 1 mg tablet, down 28% from $0.138 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Eszopiclone 1 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Eszopiclone 1 mg tablet | Generic | $0.0993 per tablet | $2.98 | -28% |
| Eszopiclone 2 mg tablet | Generic | $0.091 per tablet | $2.73 | -2% |
| Eszopiclone 3 mg tablet | Generic | $0.0877 per tablet | $2.63 | -5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has eszopiclone been recalled?
The FDA's Enforcement Report lists 4 recalls naming eszopiclone since 2013: 0 Class I (the most serious), 3 Class II, 1 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of eszopiclone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 4, 2024 | Class III | Dr. Reddy's Laboratories, Inc. | Failed Impurities/Degradation Specifications: Related Substances |
| June 16, 2022 | Class II | Macleods Pharma Usa Inc | Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. |
| March 15, 2021 | Class II | Cardinal Health Inc. not a listed maker | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the eszopiclone label say about other medicines?
The eszopiclone label names 9 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name eszopiclone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | drug interactions | Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly. |
| Itraconazole | drug interactions | Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly. |
| Ketoconazole | drug interactions | Ketoconazole: Combination use increases exposure and effect of eszopiclone. |
| Lorazepam | drug interactions | Eszopiclone and lorazepam decreased each other’s C max by 22%. |
| Nefazodone | drug interactions | Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly. |
| Nelfinavir | drug interactions | Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly. |
| Olanzapine | drug interactions | Coadministration of eszopiclone and olanzapine produced a decrease in DSST scores. |
| Paroxetine | drug interactions | There were no pharmacokinetic or pharmacodynamic interactions between eszopiclone and paroxetine. |
| Ritonavir | drug interactions | Other strong inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) would be expected to behave similarly. |
Other labels that name eszopiclone
Source: FDA drug label (Eszopiclone), Glenmark Pharmaceuticals Inc. USA, effective January 30, 2026 (SPL set 584dc66c-063a-4552-a056-74b811e2bc80), via openFDA; the full label on DailyMed
What do FAERS reports show for eszopiclone?
The FDA Adverse Event Reporting System holds 25,313 reports that list eszopiclone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,683 are coded as a death and 4,670 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as eszopiclone?
11 other medicines are given the same way (oral) and in the same FDA class as eszopiclone or labeled mainly for the same use (insomnia), the same class first. Insomnia lists all 14 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Zolpidem | Insomnia | 39 labelers | $0.0344 per tablet 5 mg tablet | No current entry |
| Temazepam | Insomnia | 20 labelers | $0.0767 per capsule 15 mg capsule | No current entry |
| Ramelteon | Insomnia | 27 labelers | $0.660 per tablet 8 mg tablet | A presentation being discontinued |
| Zaleplon | Insomnia | 9 labelers | $0.141 per capsule 10 mg capsule | No current entry |
| Triazolam | Insomnia | 7 labelers | $0.308 per tablet 0.25 mg tablet | No current entry |
| Estazolam | Insomnia | 3 labelers | $0.839 per tablet 2 mg tablet | No current entry |
| Suvorexant | Insomnia | none listed | $15.21 per tablet 10 mg tablet | No current entry |
| Daridorexant | Insomnia | none listed | $16.70 per tablet 25 mg tablet | No current entry |
Every medicine labeled for the same conditions as eszopiclone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does eszopiclone compare with medicines for the same use?
6 side-by-side pages set eszopiclone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to eszopiclone
- 11 medicines for the same use
- Eszopiclone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other