What this pack is
LUNESTA is the brand name in this record; eszopiclone film-coated tablets is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
LUNESTAGeneric nameeszopiclone film-coated tablets
How this medicine works
The label states that the precise mechanism is unknown; effects are believed to involve interaction with the GABA receptor complex at binding domains close to or allosterically coupled to benzodiazepine receptors. ‘Nonbenzodiazepine’ does not mean no sedation, behavioural, dependence, withdrawal or next-day effect, and mechanism cannot select a medicine for an individual.
Read source: United States ↗Current regulatory record · reviewed 2026-09-02More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- LUNESTA
- Source-scoped market brand names
- LUNESTA · United StatesCurrent regulator record ↗NDA 021476; the current label lists three 30-tablet bottles at 1, 2 and 3 mg. A regulatory label is not live supply or individual suitability.
The evidence status and note below apply only to the stated market and source. They do not prove that packs in different markets can be substituted.
- Generic name
- eszopiclone film-coated tablets
- Dosage-form class
- Dosage form and presentation as documented in the linked primary label
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
How to read a score line: ‘scored’ or ‘unscored’ first identifies this labelled presentation. A score line by itself does not permit self-splitting, reducing or changing the product. Only an explicit statement in the current label for this exact presentation, checked with a pharmacist against the prescription, can support any further handling.
3 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · Current U.S. DailyMed brand label (revised Jul 2023)
Eszopiclone 1 mg per tablet; 30-tablet bottle
- Product code
- NDC 80725-010-30
- Form and route
- LUNESTA eszopiclone film-coated oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- eszopiclone
- 1 mglabelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- light blue · round film-coated tablet; current label does not list a score · imprint S190Unscored; do not infer splitting permission
United States label · Current U.S. DailyMed brand label (revised Jul 2023)
Eszopiclone 2 mg per tablet; 30-tablet bottle
- Product code
- NDC 80725-011-30
- Form and route
- LUNESTA eszopiclone film-coated oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- eszopiclone
- 2 mglabelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- white · round film-coated tablet; current label does not list a score · imprint S191Unscored; do not infer splitting permission
United States label · Current U.S. DailyMed brand label (revised Jul 2023)
Eszopiclone 3 mg per tablet; 30-tablet bottle
- Product code
- NDC 80725-012-30
- Form and route
- LUNESTA eszopiclone film-coated oral tablet · oral
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-09-02; actual marketing, stock and availability are not established.
- eszopiclone
- 3 mglabelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- dark blue · round film-coated tablet; current label does not list a score · imprint S193Unscored; do not infer splitting permission
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
LUNESTA enlarged label: mg per tablet, complex sleep behaviours, next-day alertness and additive sedation
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
The 1, 2 and 3 mg figures are eszopiclone per tablet; 30 Tablets is the bottle count. The label has a boxed warning for complex sleep behaviours. The site explains the exact pack and safety questions but generates no tablet count, timing, make-up, taper or switch from nights of insomnia or last night's sleep.
- Sleep-walking, sleep-driving, preparing food, making calls or another activity while not fully awake can occur on the first or a later use, even without prior history or alcohol, and can cause serious injury. Do not self-rechallenge; contact the prescriber promptly, and use local emergency care for immediate danger.
- Next-day sleepiness and impaired reaction, memory or coordination can affect driving, equipment use and fall risk. Older adults, people who rise at night or plan early driving need review of the full situation. Feeling awake is not proof of safety.
- Alcohol, opioids, benzodiazepine anxiolytics, another sleep medicine, a sedating antihistamine or another CNS depressant can add sedation, breathing and coordination risk. Do not self-space, rotate or combine them.
- The label also addresses adequate time for sleep, slower absorption after a heavy meal, strong CYP3A4 inhibitors, liver and respiratory function, depression/suicidality, withdrawal effects and unpleasant taste. The prescriber should assess any change using the exact pack and complete medicine list.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-09-02
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 1
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): current U.S. LUNESTA eszopiclone brand label, Medication Guide and three 30-tablet bottle panels ↗Current regulatory record · reviewed 2026-09-02
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about LUNESTA (eszopiclone film-coated tablets). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
LUNESTA is the brand in this record and eszopiclone film-coated tablets is the active-ingredient name. Check both with the dosage form (Dosage form and presentation as documented in the linked primary label) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
HOW IT WORKS · NOT A TREATMENT PLAN
How eszopiclone promotes sleep: action at the GABA receptor complex does not permit addition to other sedatives
- LUNESTA, AMBIEN, zopiclone, DAYVIGO, BELSOMRA, benzodiazepines and sedating antihistamines are not one medicine. A shared sleep-related use creates no milligram conversion or rotation table.
- For an older adult with many medicines, include OTC cold/allergy products, pain medicines, anxiolytics, antidepressants, alcohol and supplements. Different brands do not exclude additive sedation.
- Insomnia may relate to pain, breathing, depression/anxiety, circadian rhythm, medicines or another condition. A mechanism cannot tell the site to add, switch, stop a medicine or order genetic screening.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): current U.S. LUNESTA eszopiclone brand label, Medication Guide and three 30-tablet bottle panels ↗Current regulatory record · reviewed 2026-09-02
- FDA: LUNESTA NDA 021476/S-038 supplemental approval letter for the boxed warning on complex sleep behaviours (2019) ↗reviewed 2026-09-02
- FDA: original LUNESTA NDA 021476 approval package (15 Dec 2004) ↗reviewed 2026-09-02
SOURCE-TRACEABLE ARCHIVE
LUNESTAeszopiclone film-coated tablets
This page includes an exact current U.S. public-label package panel for LUNESTA, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Original U.S. approval of LUNESTA
The FDA original approval package lists 1, 2 and 3 mg eszopiclone tablets for insomnia.
FDA: original LUNESTA NDA 021476 approval package (15 Dec 2004) ↗FDA approved the boxed warning for complex sleep behaviours
NDA 021476/S-038 updated the label for NREM parasomnias and recorded the risk of serious injury.
FDA: LUNESTA NDA 021476/S-038 supplemental approval letter for the boxed warning on complex sleep behaviours (2019) ↗Current DailyMed brand-label revision
The current label, Medication Guide and three Waylis 30-tablet bottle panels are publicly readable.
DailyMed (NLM): current U.S. LUNESTA eszopiclone brand label, Medication Guide and three 30-tablet bottle panels ↗
MARKET SCOPE
Market-record boundary
United States
Current public brand labelNDA 021476; 1, 2 and 3 mg in three 30-tablet bottles; U.S. C-IV.
Markets outside the United States
Local brand, legal classification, pack and supply are not establishedNames such as eszopiclone and zopiclone require item-by-item checking against the local regulator and pack in hand.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Are LUNESTA, zopiclone, zolpidem and DAYVIGO the same medicine?
No. Their ingredients, products, mechanism details, market records and label boundaries differ. Brand, colour, purpose or milligrams do not permit self-conversion, rotation or combination.
Can I take more or add another sleep medicine after a poor night?
The site cannot make that decision. Increasing or combining can increase complex sleep behaviour, next-day impairment, falls and breathing risk. Have the prescriber or pharmacist review the exact pack, prescription, available sleep time, alcohol and complete medicine list.
The tablet is small. Can it be split or assembled with another strength?
Do not infer from appearance or total milligrams. The current label does not turn a score or splitting into permission for individual adjustment. Review the exact prescription before changing strength, tablet count or stopping.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.