What this pack is
DAYVIGO is the brand name in this record; lemborexant is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
DAYVIGOGeneric namelemborexant
How this medicine works
Lemborexant is a dual orexin-receptor antagonist that binds OX1R and OX2R and suppresses wake-promoting orexin signalling. In plain language, it reduces one wake-maintaining signal rather than ‘switching off’ all brain activity. This mechanism cannot predict individual suitability, strength choice or safe combination with another sleep or sedative medicine.
Read source: United States ↗Current regulatory record · reviewed 2026-08-30More 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
- DAYVIGO
- Generic name
- lemborexant
- 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.
7 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 public label (SPL v39; updated Feb 2025)
Lemborexant 5 mg per tablet; 30-tablet bottle
- Product code
- NDC 62856-405-30
- Form and route
- DAYVIGO lemborexant oral film-coated tablet · oral; exact product-identity field, not an individual tablet count or timing
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lemborexant
- 5 mglabelled amount per tablet; not an individual's tablet count, frequency, make-up, stopping or switching instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- pale yellow · round film-coated tablet; unscored · imprint 5;LEMUnscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v39; updated Feb 2025)
Lemborexant 5 mg per tablet; 90-tablet bottle
- Product code
- NDC 62856-405-90
- Form and route
- DAYVIGO lemborexant oral film-coated tablet · oral; exact product-identity field, not an individual tablet count or timing
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lemborexant
- 5 mglabelled amount per tablet; not an individual's tablet count, frequency, make-up, stopping or switching instruction
- Package
- 90 tablets per bottle
- Labelled appearance
- pale yellow · round film-coated tablet; unscored · imprint 5;LEMUnscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v39; updated Feb 2025)
Lemborexant 10 mg per tablet; 30-tablet bottle
- Product code
- NDC 62856-410-30
- Form and route
- DAYVIGO lemborexant oral film-coated tablet · oral; exact product-identity field, not an individual tablet count or timing
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lemborexant
- 10 mglabelled amount per tablet; not an individual's tablet count, frequency, make-up, stopping or switching instruction
- Package
- 30 tablets per bottle
- Labelled appearance
- orange · round film-coated tablet; unscored · imprint 10;LEMUnscored in this labelled presentation
United States label · Current U.S. DailyMed public label (SPL v39; updated Feb 2025)
Lemborexant 10 mg per tablet; 90-tablet bottle
- Product code
- NDC 62856-410-90
- Form and route
- DAYVIGO lemborexant oral film-coated tablet · oral; exact product-identity field, not an individual tablet count or timing
- Container
- bottle
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lemborexant
- 10 mglabelled amount per tablet; not an individual's tablet count, frequency, make-up, stopping or switching instruction
- Package
- 90 tablets per bottle
- Labelled appearance
- orange · round film-coated tablet; unscored · imprint 10;LEMUnscored in this labelled presentation
JP · Current Japanese PMDA electronic label (revised 10 Dec 2025; verified 30 Aug 2026)
Lemborexant 2.5 mg per tablet; Japanese PMDA product identity
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- PMDA 30200AMX00017000
- Form and route
- DAYVIGO lemborexant oral film-coated tablet (Japan) · oral (exact Japanese product-identity field)
- Container
- exact pack count not established in this identity card
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lemborexant
- 2.5 mgJapanese labelled amount per tablet; not an individual's tablet count, age-based regimen or cross-market conversion
- Labelled appearance
- pale red · round film-coated tablet; about 7.1 mm diameter and 3.3 mm thick; unscored · imprint LЄM 2.5Unscored in this labelled presentation
JP · Current Japanese PMDA electronic label (revised 10 Dec 2025; verified 30 Aug 2026)
Lemborexant 5 mg per tablet; Japanese PMDA product identity
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- PMDA 30200AMX00018000
- Form and route
- DAYVIGO lemborexant oral film-coated tablet (Japan) · oral (exact Japanese product-identity field)
- Container
- exact pack count not established in this identity card
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lemborexant
- 5 mgJapanese labelled amount per tablet; not an individual's tablet count, age-based regimen or cross-market conversion
- Labelled appearance
- slightly yellow · round film-coated tablet; about 7.1 mm diameter and 3.3 mm thick; unscored · imprint LЄM 5Unscored in this labelled presentation
JP · Current Japanese PMDA electronic label (revised 10 Dec 2025; verified 30 Aug 2026)
Lemborexant 10 mg per tablet; Japanese PMDA product identity
Source-text identity card: no displayable exact official package image. The fields below come from the cited label and are not a visual authentication result.
- Product code
- PMDA 30200AMX00019000
- Form and route
- DAYVIGO lemborexant oral film-coated tablet (Japan) · oral (exact Japanese product-identity field)
- Container
- exact pack count not established in this identity card
- Listing review
- Cited public label display reviewed 2026-08-30; actual marketing, stock and availability are not established.
- lemborexant
- 10 mgJapanese labelled amount per tablet; not an individual's tablet count, age-based regimen or cross-market conversion
- Labelled appearance
- orange · round film-coated tablet; about 7.1 mm diameter and 3.3 mm thick; unscored · imprint LЄM 10Unscored in this labelled presentation
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
DAYVIGO label reading: check mg per tablet, next-day alertness, falls and the full medicine list
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.
U.S. 5 and 10 mg and Japanese 2.5, 5 and 10 mg figures are labelled lemborexant amounts per tablet, not a personal regimen supplied by this site. Alcohol, opioids, other sleep or sedative medicines and other CNS depressants can add drowsiness, slowed reactions, breathing or fall risk.
- The pack mg identifies strength and is not a tablet count. U.S. and Japanese strengths and label wording differ; this site does not generate an individual tablet count, timing or missed-use action from age, insomnia duration or market.
- Lemborexant can affect next-day alertness, attention, driving and motor coordination. If an older adult remains markedly drowsy, unsteady on standing or has a fall, do not drive, operate hazardous equipment, add another sleep medicine or use alcohol; seek timely professional review.
- Sleep-walking, sleep-driving, eating, making calls or other activities while not fully awake are complex-sleep-behaviour warnings. Secure safety and contact the prescriber immediately; injury, altered awareness, breathing difficulty or another acute danger requires local emergency support.
- Sleep paralysis, hallucination-like experiences around sleep or waking, or temporary leg weakness should be recorded with timing and co-medications and reviewed professionally. The site cannot diagnose from these events or direct an individual increase, decrease or stop.
- Alcohol, opioids, benzodiazepines, allergy medicines and other CNS depressants can add risk. Strong or moderate CYP3A inhibitors and inducers can also affect professional management. Bring prescription medicines, OTC products, supplements and the full list for item-by-item review.
- DAYVIGO, BELSOMRA and AMBIEN are different medicines. Even though they may be used for sleep, and DAYVIGO and BELSOMRA are both dual orexin-receptor antagonists, they cannot be converted by mg, self-rotated on alternate days, combined or substituted with leftovers.
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 · 2026-08-30
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
- Japan · 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. DAYVIGO lemborexant oral-tablet public label, Medication Guide and four bottle panels (SPL v39; updated Feb 2025) ↗Current regulatory record · reviewed 2026-08-30
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- PMDA · Japan · Regulatory product record · 2026-08-30Japan PMDA: current DAYVIGO 2.5/5/10 mg electronic label (revised 10 Dec 2025) ↗Current regulatory record · reviewed 2026-08-30
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 DAYVIGO (lemborexant). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
DAYVIGO is the brand in this record and lemborexant 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.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- DailyMed (NLM): current U.S. DAYVIGO lemborexant oral-tablet public label, Medication Guide and four bottle panels (SPL v39; updated Feb 2025) ↗Current regulatory record · reviewed 2026-08-30
- Japan PMDA: current DAYVIGO 2.5/5/10 mg electronic label (revised 10 Dec 2025) ↗Current regulatory record · reviewed 2026-08-30
HOW IT WORKS · NOT A TREATMENT PLAN
How lemborexant works: blocking OX1R and OX2R orexin receptors to reduce wake signalling
- Membership in the dual orexin-receptor-antagonist class does not make DAYVIGO, BELSOMRA and QUVIVIQ one medicine or permit one-for-one milligram substitution, combination or rotation.
- A different mechanism from AMBIEN and other sleep medicines does not make one better for everyone. The full medicine list, next-day activity needs, fall and breathing risks and professional assessment can all affect individual management.
- Mechanism helps explain pharmacology and interaction boundaries; it does not diagnose the cause from sleep duration or symptoms, select treatment, set a tablet count or displace full label warnings such as next-day drowsiness and complex sleep behaviours.
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. DAYVIGO lemborexant oral-tablet public label, Medication Guide and four bottle panels (SPL v39; updated Feb 2025) ↗Current regulatory record · reviewed 2026-08-30
- FDA: DAYVIGO (lemborexant) NDA 212028 original approval letter (2019) ↗reviewed 2026-08-30
- FDA: DAYVIGO lemborexant NDA 212028 multidisciplinary review ↗reviewed 2026-08-30
- FDA: DAYVIGO NDA 212028/S-008 supplemental approval letter (2023) ↗reviewed 2026-08-30
- Japan PMDA: current professional product records, electronic label and patient information access for DAYVIGO 2.5/5/10 mg ↗Current regulatory record · reviewed 2026-08-30
- Japan PMDA: current DAYVIGO 2.5/5/10 mg electronic label (revised 10 Dec 2025) ↗Current regulatory record · reviewed 2026-08-30
- Japan PMDA: patient medicine guide for DAYVIGO 2.5/5/10 mg ↗Current regulatory record · reviewed 2026-08-30
- Japan PMDA: new-drug review report for DAYVIGO (lemborexant) ↗reviewed 2026-08-30
SOURCE-TRACEABLE ARCHIVE
DAYVIGOlemborexant
This page includes an exact current U.S. public-label package panel for DAYVIGO, 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
Initial U.S. NDA 212028 approval
The FDA approval record links DAYVIGO, lemborexant and Eisai. Approval does not establish real-time local stock or individual suitability.
FDA: DAYVIGO (lemborexant) NDA 212028 original approval letter (2019) ↗Japanese DAYVIGO product approvals
Current PMDA records list 2.5, 5 and 10 mg products. Japanese strengths and wording do not automatically transfer to the United States or another market.
Japan PMDA: current professional product records, electronic label and patient information access for DAYVIGO 2.5/5/10 mg ↗U.S. DailyMed SPL v39 update
The current public label displays four exact bottle panels, a Medication Guide and safety wording.
DailyMed (NLM): current U.S. DAYVIGO lemborexant oral-tablet public label, Medication Guide and four bottle panels (SPL v39; updated Feb 2025) ↗
MARKET SCOPE
Market-record boundary
United States
Current brand label and four exact bottles linkedThe page lists 5/10 mg in 30/90-tablet bottles; it does not establish pharmacy stock, purchase eligibility or individual suitability.
Japan
Current 2.5/5/10 mg products, electronic label and patient guide linked; no exact package image establishedThe three Japanese identity cards use PMDA text only and do not borrow U.S. pack images.
Mainland China and other markets
Current market record not establishedNo local approval, supply, originator/generic relationship or interchangeability is inferred from a U.S. or Japanese brand, colour, imprint or milligram number.
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 DAYVIGO and BELSOMRA the same medicine?
No. DAYVIGO contains lemborexant and BELSOMRA contains suvorexant. Shared orexin-receptor activity does not permit self-substitution, combination or rotation by milligrams.
Can an older adult halve the tablet after morning drowsiness or a fall?
Do not self-split, reduce or stop from this page. Avoid driving and hazardous activity, record the actual pack, timing, alcohol and every co-medication, and contact the prescriber or pharmacist promptly. Altered awareness, serious injury or breathing difficulty requires local emergency help.
Can U.S. and Japanese 5 mg or 10 mg products be directly interchanged?
Not from a shared milligram figure. Market approval, prescription, pack, excipients, supply system and current label all require separate review. The Japanese identity cards have no package image here, so a U.S. image cannot authenticate them.
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.