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DAYVIGO lemborexant 5 mg Tablet, Film Coated, 90-count — NDC 62856-0405-90 package photo

DAYVIGO lemborexant 5 mg Tablet, Film Coated, 90-count

by Eisai Inc. · 90 TABLET, FILM COATED in 1 BOTTLE (62856-405-90)
NDC 62856-0405-90
🏷️ FDA NDC (as labeled) 62856-405-90 billing pads the product segment with a zero
This package
Contains90-count Pack sizes3 compare ↓
Also priced by: Part D plans $11.59/unit — full pricing hub ↓
Also comes in: 10 tablets 62856-0405-10 30 tablets 62856-0405-30
Rx only Brand On market CIV
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 62856-405-90
Product NDC 62856-405
11-digit billing NDC 62856040590
RxCUI 2272408, 2272414, 2288425, 2288427
UNII 0K5743G68X
UPC 0362856410304, 0362856405300, 0362856410908, 0362856405904
Application # NDA212028
SPL Set ID 7074cb65-77b3-45d2-8e8d-da8dc0f70bfd
Established class (EPC) Orexin Receptor Antagonist
Mechanism of action Orexin Receptor Antagonists; Cytochrome P450 2B6 Inducers
DEA schedule CIV
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-07
Route ORAL
Dosage form TABLET, FILM COATED
Substance LEMBOREXANT
GPI-14 60500040000320
GPI class DayVigo
GCN Seq No 080590
GCN 47479
HICL code 046275
Ingredient (HICL) Lemborexant
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2E
Therapeutic class — specific (HIC3) Sedative-Hypnotics,Non-Barbiturate
AHFS code 28:24.40.00
AHFS class Orexin Receptor Antagonists
FDB label name DAYVIGO 5 MG TABLET
FDB brand name Dayvigo
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 62856-405-90 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62856-0405-90. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Orexin Receptor Antagonist class.

Pharmacologic class Orexin Receptor Antagonist
Drug family (ATC) Orexin receptor antagonists
How it works Cytochrome P450 2B6 Inducers, Orexin Receptor Antagonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerEisai Inc.
Application holderEISAI INC
FDA applicationNDA212028 (NDA)
Labeler code62856
First marketedApr 2020
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio28 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DAYVIGO 5 MG TABLET Ingredient Lemborexant
📖 What it is MedlinePlus · NLM

Lemborexant is used to treat insomnia (difficulty falling asleep or staying asleep). Lemborexant belongs to a class of medications called hypnotics. It works by slowing activity in the brain to allow sleep.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Your brain has a built-in wake system driven by chemicals called orexins. When those orexins are active, they keep you alert. Dayvigo blocks the receptors those chemicals attach to...
  • What exactly does Dayvigo do — how does it help me sleep?
  • Take Dayvigo right before you get into bed — only when you have at least 7 full hours before you need to wake up. It's best to take it away from a big meal. If you eat a heavy, hig...
  • When should I take it, and does it matter if I eat first?
📖 Read our full Lemborexant guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color yellow / orange
ShapeRound
Imprint5;LEM
Size7 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 8VAB711C5E
    Hydroxypropyl cellulose is a plant-based thickener made from cellulose. In medicines, it acts as a binder to hold ingredients together, a coating to protect the tablet or capsule, and a thickener to create the right texture in liquids or gels.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII NZ94SDL6WR
    Low-substituted hydroxypropyl cellulose is a plant-based thickener and binder made from cellulose. It helps hold the medicine together, controls how quickly it dissolves, and improves texture in tablets and capsules.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $11.59 $1,042.83 / 90 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dayvigo 5 mgthis 62856-0405-90 Eisai 90 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
First FDA approval
Apr 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Oct 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 7, 2020 RLD RS ⏳ ~9.1 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8268848 — drug substance (U-2791)
US 10188652 — method of use (U-2791)
US 10188652 — method of use (U-2791)
US 8268848 — drug substance (U-2791)
US 11026944 — drug product
US 10702529 — drug product
US 11026944 — drug product
US 10702529 — drug product
Exclusivity M-293
Exclusivity M-293
2020 2022 2024 2026 2028 2030 2032 2034
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (8)
PatentTypeUse codeExpires
US 8268848 ↗ Drug substance U-2791 Sep 20, 2031
US 10188652 ↗ Method of use U-2791 Oct 21, 2035
US 10188652 ↗ Method of use U-2791 Oct 21, 2035
US 8268848 ↗ Drug substance U-2791 Sep 20, 2031
US 11026944 ↗ Drug product — Oct 21, 2035
US 10702529 ↗ Drug product — Oct 21, 2035
US 11026944 ↗ Drug product — Oct 21, 2035
US 10702529 ↗ Drug product — Oct 21, 2035
FDA exclusivity
CodeWhat it grantsExpires
M-293New indication / labeling change (3-year)Apr 20, 2026
M-293New indication / labeling change (3-year)Apr 20, 2026
Common questions
Is there a generic version of DAYVIGO 5 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for DAYVIGO 5 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Oct 2035 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 tablets62856-0405-30 4,805 Rx · $1,611,715
10 tablets62856-0405-10 No Medicaid data
90 tablets this page62856-0405-90 No Medicaid data
Drug total (last 4 qtrs): 4,805 Rx · 140,803 units · $1,611,715 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Dayvigo — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Dayvigo. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$7.15M
Claims incl. refills
18.7K
Beneficiaries
10K
Spend / beneficiary
$715.60
Spend / claim
$382.51
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for DAYVIGO (this brand).

Top reported reactions

Suicide Attempt148
Somnolence140
Condition Aggravated131
Suicidal Ideation130
Fall105
Nausea95
Headache93

Reporter sex

2,745 reports

Serious outcomes

Death326
Life-threatening192
Disabling68
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 598 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
62856-0405-10 1 BLISTER PACK in 1 CARTON (62856-405-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK — — 2020-04-07 Active
62856-0405-30 30 TABLET, FILM COATED in 1 BOTTLE (62856-405-30) $11.58 / ea $347.41 2020-04-07 Active
62856-0405-90 You're viewing this 90 TABLET, FILM COATED in 1 BOTTLE (62856-405-90) — — 2020-04-07 Active

This pack shows little to no recent Medicaid volume — the 30 tablets pack carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 62856-0405-90?
NDC 62856-0405-90 is a 90-count package — 90 tablet, film coated in 1 bottle.
What is the difference between NDC 62856-0405-90 and NDC 62856-0405-10?
Both are DAYVIGO lemborexant 5 mg Tablet, Film Coated — the drug itself is identical. NDC 62856-0405-90 is the 90-count package, while NDC 62856-0405-10 is the 10 tablets package.
What NDC number is used to bill for this package of DAYVIGO lemborexant 5 mg Tablet, Film Coated?
Bill NDC 62856-0405-90 — the 11-digit billing format is 62856040590. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 62856-405-90, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 62856-0405-90, written without dashes as 62856040590. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 62856-0405-90, the first segment (62856) is the labeler code FDA assigned to Eisai Inc.; the middle segment (0405) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Eisai Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 10 tablets (62856-0405-10), 30 tablets (62856-0405-30). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Eisai Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 58 words ▾

1 INDICATIONS AND USAGE DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies ( 14.1 )] . DAYVIGO is an orexin receptor antagonist indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dose is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. Dosage may be increased to 10 mg based on clinical response and tolerability. ( 2.1 ) The maximum recommended dose is 10 mg once daily.

( 2.1 ) Time to sleep onset may be delayed if taken with or soon after a meal. ( 2.1 ) Hepatic Impairment: ( 2.3 ) ○ Moderate hepatic impairment: Initial and maximum recommended dosage is 5 mg no more than once per night. ○ Severe hepatic impairment: Not recommended.

2.1Dosing Information The recommended dosage of DAYVIGO is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. The dose may be increased to the maximum recommended dose of 10 mg based on clinical response and tolerability. Time to sleep onset may be delayed if taken with or soon after a meal [see Clinical Pharmacology ( 12.3 )].

2.2Dosage Recommendations for Concomitant Use with CYP3A Inhibitors or CYP3A Inducers Co-administration with Strong or Moderate CYP3A Inhibitors Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )]. Co-administration with Weak CYP3A Inhibitors The maximum recommended dosage of DAYVIGO is 5 mg no more than once per night when co-administered with weak CYP3A inhibitors [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )]. Co-administration with Strong or Moderate CYP3A Inducers Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )].

2.3Dosage Recommendations for Patients with Hepatic Impairment The maximum recommended dose of DAYVIGO is 5 mg no more than once per night in patients with moderate hepatic impairment [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )]. DAYVIGO is not recommended in patients with severe hepatic impairment [see Use in Specific Populations ( 8.7 )].

💊 Dosage Forms and Strengths 62 words ▾

3 DOSAGE FORMS AND STRENGTHS DAYVIGO (lemborexant) tablets are available as: 5 mg tablets: pale yellow, round, biconvex, film-coated tablets, and debossed with "5" on one side and "LЄM" on the other side. 10 mg tablets: orange, round, biconvex, film-coated tablets, and debossed with "10" on one side and "LЄM" on the other side. Tablets: 5 mg, 10 mg ( 3 )

⛔ Contraindications 19 words ▾

4 CONTRAINDICATIONS DAYVIGO is contraindicated in patients with narcolepsy. DAYVIGO is contraindicated in patients with narcolepsy. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS CNS Depressant Effects and Daytime Impairment: Impairs alertness and motor coordination including morning impairment. Risk increases with dose and use with other central nervous system (CNS) depressants. For patients taking DAYVIGO 10 mg, caution against next-day driving and other activities requiring complete mental alertness.

( 5.1 ) Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with use of DAYVIGO. ( 5.2 ) Complex Sleep Behaviors: Behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur. Discontinue immediately if a complex sleep behavior occurs.

( 5.3 ) Compromised Respiratory Function: Effect on respiratory function should be considered. ( 5.4 , 8.8 ) Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Prescribe the lowest number of tablets feasible to avoid intentional overdosage.

( 5.5 ) Need to Evaluate for Co-morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of treatment. ( 5.6 )

5.1CNS Depressant Effects and Daytime Impairment DAYVIGO is a central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed. CNS depressant effects may persist in some patients for up to several days after discontinuing DAYVIGO. Prescribers should advise patients about the potential for next-day somnolence.

Driving ability was impaired in some subjects taking DAYVIGO 10 mg [see Clinical Studies ( 14.2 )]. The risk of daytime impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or if a higher than recommended dose is taken [see Dosage and Administration ( 2.1 )]. If DAYVIGO is taken in these circumstances, patients should be cautioned against driving and other activities requiring complete mental alertness.

Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression, which can cause daytime impairment. Dosage adjustments of DAYVIGO and of concomitant CNS depressants may be necessary when administered together because of potentially additive effects. The use of DAYVIGO with other drugs to treat insomnia is not recommended .

Patients should be advised not to consume alcohol in combination with DAYVIGO because of additive effects [see Drug Interactions ( 7.1 )]. Because DAYVIGO can cause drowsiness, patients, particularly the elderly, are at a higher risk of falls.

5.2Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy - l ike Symptoms Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, and hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions, can occur with the use of DAYVIGO. Prescribers should explain the nature of these events to patients when prescribing DAYVIGO. Symptoms similar to mild cataplexy can occur with DAYVIGO.

Such symptoms can include periods of leg weakness lasting from seconds to a few minutes, can occur either at night or during the day, and may not be associated with an identified triggering event (e.g., laughter or surprise).

5.3Complex Sleep Behaviors Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the use of hypnotics such as DAYVIGO. These events can occur in hypnotic-naïve as well as in hypnotic-experienced persons. Patients usually do not remember these events.

Complex sleep behaviors may occur following the first or any subsequent use of DAYVIGO, with or without the concomitant use of alcohol and other CNS depressants [see Drug Interactions ( 7.1 )] . Discontinue DAYVIGO immediately if a patient experiences a complex sleep behavior.

5.4 Patients with Compromised Respiratory Function DA…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: CNS Depressant Effects and Daytime Impairment [see Warnings and Precautions ( 5.1 )] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms [see Warnings and Precautions ( 5.2 )] Complex Sleep Behaviors [see Warnings and Precautions ( 5.3 )] Patients with Compromised Respiratory Function [see Warnings and Precautions ( 5.4 )] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions ( 5.5 )] The most common adverse reaction (reported in ≥5% of patients treated with DAYVIGO and at least twice the rate of placebo) was somnolence.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of DAYVIGO was evaluated in 1418 adult patients with insomnia disorder (age 18 to 88 years) from two controlled efficacy trials (Study 1 and Study 2). Study 1 was a 6-month placebo-controlled trial assessing DAYVIGO 5 or 10 mg once nightly, followed by a 6-month parallel-group extension period in which patients initially treated with DAYVIGO continued on the same dose, and patients who received placebo were re-randomized to receive DAYVIGO 5 or 10 mg once nightly.

In Study 1, 434 patients were treated with DAYVIGO for one year. Study 2 was a 30-day placebo- and active-controlled trial assessing DAYVIGO 5 or 10 mg once nightly. Adverse Reactions Resulting in Discontinuation of Treatment The frequencies of discontinuation due to adverse reactions in Study 1 (the first 30 days) and Study 2 were 2.6% and 1.4% for patients treated with 10 mg and 5 mg DAYVIGO, respectively, compared to 1.5% for patients in the placebo group.

The most common adverse reactions leading to discontinuation of DAYVIGO were somnolence (1.0% for 10 mg, 0.7% for 5 mg, and 0.4% for placebo) and nightmares (0.3% for 10 mg, 0.3% for 5 mg, and 0% for placebo). The frequencies of discontinuation due to adverse reactions in the 6-month placebo-controlled period of Study 1 were 8.3% and 4.1% for patients treated with DAYVIGO 10 mg and 5 mg, respectively, compared to 3.8% for patients in the placebo group. The most common reasons for discontinuation of DAYVIGO and occurring in more than one patient within a treatment arm were somnolence (2.9% for 10 mg, 1.0% for 5 mg, and 0.6% for placebo), nightmares (1.3% for 10 mg, 0.3% for 5 mg, and 0% for placebo), and palpitations (0.6% for 10 mg, 0% for 5 mg, and 0% for placebo).

Most Common Adverse Reactions The most common adverse reaction (reported in 5% or more of patients treated with DAYVIGO and at least twice the rate of placebo) in Study 1 (the first 30 days) and Study 2 was somnolence (10% for DAYVIGO 10 mg, 7% for DAYVIGO 5 mg, and 1% for placebo). Table 1 presents the adverse reactions based on the pooled data from the first 30 days of Study 1 (6-month controlled efficacy trial) and Study 2 (1-month controlled efficacy trial) where the incidence was ≥2% in DAYVIGO-treated patients and greater than in placebo-treated patients.

Table 1: Adverse Reactions Reported in ≥ 2% of DAYVIGO-Treated Patients and at a Greater Frequency than Placebo-Treated Patients During the First 30 D ays of Study 1 and Study 2 DAYVIGO Placebo 5 mg 10 mg n=528 n=580 n=582 (%) (%) (%) Somnolence or fatigue * 1.3 6.9

9.6Headache 3.4 5.9

4.5Nightmare or abnormal dreams 0.9 0.9 2.2 * Combines preferred terms somnolence, lethargy, fatigue, sluggishness Other Adverse Reactions Observed During Clinical Trials (Studies 1 and 2) Other adverse reactions of <2% incidence but greater than placebo are shown below. The follow…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Strong or moderate CYP3A inhibitors: Avoid concomitant use. ( 7.1 ) Weak CYP3A inhibitors: The maximum recommended dose is 5 mg. ( 2.2 , 7.1 ) Strong or moderate CYP3A inducers: Avoid concomitant use. ( 7.1 )

7.1Drugs Having Clinically Important Interactions with DAYVIGO Table 2: Clinically Important Drug Interactions with DAYVIGO Effect of Other Drugs on DAYVIGO Strong, Moderate, and Weak CYP3A Inhibitors Clinical Impact: Concomitant use with a strong, moderate, or weak CYP3A inhibitor increases lemborexant AUC and C max which may increase the risk of DAYVIGO adverse reactions [see Clinical Pharmacology ( 12.3 )]. Intervention: Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inhibitors [see Dosage and Administration ( 2.2 )].

The maximum recommended dose of DAYVIGO with weak CYP3A inhibitors is 5 mg [see Dosage and Administration ( 2.2 )]. Examples: Strong CYP3A inhibitors: itraconazole, clarithromycin Moderate CYP3A inhibitors: fluconazole, verapamil Weak CYP3A inhibitors: chlorzoxazone, ranitidine Strong and Moderate CYP3A Inducers Clinical Impact: Concomitant use with a strong or moderate CYP3A inducer decreases lemborexant exposure, which may reduce DAYVIGO efficacy [see Clinical Pharmacology ( 12.3 )]. Intervention: Avoid concomitant use of DAYVIGO with strong or moderate CYP3A inducers [see Dosage and Administration ( 2.2 )].

Examples: Strong CYP3A inducers: rifampin, carbamazepine, St. John’s wort Moderate CYP3A inducers: bosentan, efavirenz, etravirine, modafinil Alcohol Clinical Impact: Concomitant use of alcohol increases lemborexant C max and AUC. Co-administration of DAYVIGO with alcohol produced a numerically greater negative impact on postural stability and memory as compared with alcohol alone when assessed near the t max of DAYVIGO (2 hours post-dose) [see Clinical Pharmacology ( 12.2 )].

Intervention: Avoid alcohol consumption with DAYVIGO [see Warnings and Precautions ( 5.1 )]. Effect of DAYVIGO on Other Drugs CYP2B6 Substrates Clinical Impact: Concomitant use of DAYVIGO decreases the AUC of drugs that are CYP2B6 substrates, which may result in reduced efficacy for these concomitant medications [see Clinical Pharmacology ( 12.3 )]. Intervention: Patients receiving DAYVIGO and CYP2B6 substrates concurrently should be monitored for adequate clinical response.

Increasing the doses of CYP2B6 substrates may be considered as needed. Examples: Bupropion, methadone

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to psychiatric medications, including DAYVIGO, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Psychiatric Medications, at1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry . Risk Summary There are no available data on DAYVIGO use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes.

In animal reproduction studies, oral administration of lemborexant to pregnant rats and rabbits during the period of organogenesis caused toxicities only at high multiples of the human exposure at the maximum recommended human dose (MRHD) based on AUC. The no observed adverse effect levels (NOAEL) are approximately >100 and 23 times the MRHD based on AUC in rats and rabbits, respectively. Similarly, oral administration of lemborexant to pregnant and lactating rats caused toxicities only at high multiples of the human exposure at the MRHD based on AUC.

The NOAEL is 93 times the MRHD based on AUC ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Data Animal Data Lemborexant was administered orally to pregnant rats during the period of organogenesis in 2 studies at doses of 60, 200, and 600 mg/kg/day or 20, 60, and 200 mg/kg/day, which are approximately 6 to >300 times the MRHD based on AUC. Lemborexant caused maternal toxicity, manifested by decreased body weight and food consumption, decreased mean fetal body weight, an increased number of dead fetuses, and skeletal, external and visceral malformations (omphalocele, cleft palate, and membranous ventricular septal defect) at >300 times the MRHD based on AUC.

The NOAEL of 200 mg/kg/day is approximately 143 times the MRHD based on AUC. Lemborexant was administered orally to pregnant rabbits during the period of organogenesis at doses of 10, 30, and 100 mg/kg/day, which are approximately 7 to 139 times the MRHD based on AUC. Lemborexant caused maternal toxicity that consisted of decreased body weight and food consumption and a higher incidence of skeletal variations (presence of cervical ribs and supernumerary lung lobes) at approximately 139 times the MRHD based on AUC.

The NOAEL of 30 mg/kg/day is approximately 23 times the MRHD based on AUC. Lemborexant was administered orally to pregnant rats during pregnancy and lactation at doses of 30, 100, and 300 mg/kg/day, which are approximately 15 to 206 times the MRHD based on AUC. Lemborexant caused maternal toxicity that consisted of decreased body weight and food consumption and toxicity to offspring consisting of decreased pup body weights, decreased femur length, and decreased acoustic startle responses at 206 times the MRHD based on AUC.

The NOAEL of 100 mg/kg/day is approximately 93 times the MRHD based on AUC.

8.2Lactation Risk Summary Available data from a lactation study in 8 women indicates that lemborexant is transferred into the breastmilk of nursing mothers, and the results have established a mean daily infant dose of 0.0029 mg/kg/day and a relative infant dose of less than 2% of the maternal dose. These data support that transfer of lemborexant into breastmilk is low (see Data). There are no data on the effects of lemborexant on the breastfed infant, or the effects on milk production.

Infants exposed to DAYVIGO through breastmilk should be monitored for excessive sedation. The developmental and health benefits of breastfeeding should…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to psychiatric medications, including DAYVIGO, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Psychiatric Medications, at1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry . Risk Summary There are no available data on DAYVIGO use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes.

In animal reproduction studies, oral administration of lemborexant to pregnant rats and rabbits during the period of organogenesis caused toxicities only at high multiples of the human exposure at the maximum recommended human dose (MRHD) based on AUC. The no observed adverse effect levels (NOAEL) are approximately >100 and 23 times the MRHD based on AUC in rats and rabbits, respectively. Similarly, oral administration of lemborexant to pregnant and lactating rats caused toxicities only at high multiples of the human exposure at the MRHD based on AUC.

The NOAEL is 93 times the MRHD based on AUC ( see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Data Animal Data Lemborexant was administered orally to pregnant rats during the period of organogenesis in 2 studies at doses of 60, 200, and 600 mg/kg/day or 20, 60, and 200 mg/kg/day, which are approximately 6 to >300 times the MRHD based on AUC. Lemborexant caused maternal toxicity, manifested by decreased body weight and food consumption, decreased mean fetal body weight, an increased number of dead fetuses, and skeletal, external and visceral malformations (omphalocele, cleft palate, and membranous ventricular septal defect) at >300 times the MRHD based on AUC.

The NOAEL of 200 mg/kg/day is approximately 143 times the MRHD based on AUC. Lemborexant was administered orally to pregnant rabbits during the period of organogenesis at doses of 10, 30, and 100 mg/kg/day, which are approximately 7 to 139 times the MRHD based on AUC. Lemborexant caused maternal toxicity that consisted of decreased body weight and food consumption and a higher incidence of skeletal variations (presence of cervical ribs and supernumerary lung lobes) at approximately 139 times the MRHD based on AUC.

The NOAEL of 30 mg/kg/day is approximately 23 times the MRHD based on AUC. Lemborexant was administered orally to pregnant rats during pregnancy and lactation at doses of 30, 100, and 300 mg/kg/day, which are approximately 15 to 206 times the MRHD based on AUC. Lemborexant caused maternal toxicity that consisted of decreased body weight and food consumption and toxicity to offspring consisting of decreased pup body weights, decreased femur length, and decreased acoustic startle responses at 206 times the MRHD based on AUC.

The NOAEL of 100 mg/kg/day is approximately 93 times the MRHD based on AUC.

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of DAYVIGO have not been established in pediatric patients.

🧓 Geriatric Use 167 words ▾

8.5Geriatric Use Of the total number of patients treated with DAYVIGO (n=1418) in controlled Phase 3 studies, 491 patients were 65 years and over, and 87 patients were 75 years and over. Overall, efficacy results for patients <65 years of age were similar compared to patients ≥65 years. In a pooled analysis of Study 1 (the first 30 days) and Study 2, the incidence of somnolence in patients ≥65 years with DAYVIGO 10 mg was higher (9.8%) compared to 7.7% in patients <65 years.

The incidence of somnolence with DAYVIGO 5 mg was similar in patients ≥65 years (4.9%) and <65 years (5.1%). The incidence of somnolence in patients treated with placebo was 2% or less regardless of age [see Clinical Studies ( 14.2 )]. Because DAYVIGO can increase somnolence and drowsiness, patients, particularly the elderly, are at a higher risk of falls [see Warning s and Precautions ( 5.1 )] .

Exercise caution when using doses higher than 5 mg in patients ≥65 years old.

🆘 Overdosage 141 words ▾

10 OVERDOSAGE There is limited clinical experience with DAYVIGO overdose. In clinical pharmacology studies, healthy patients who were administered multiple doses of up to 75 mg (7.5 times the maximum recommended dose) of DAYVIGO showed dose-dependent increases in the frequency of somnolence. There is no available specific antidote to an overdose of DAYVIGO.

In the event of overdose, standard medical practice for the management of any overdose should be used. In managing overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. Consult a Certified Poison Control Center for the most up to date information on the management of overdosage (1-800-222-1222 or www.poison.org).

The value of dialysis in the treatment of overdosage has not been determined with lemborexant. As lemborexant is highly protein-bound, hemodialysis is not expected to contribute to elimination of lemborexant.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY Figure 1. Effects of Hepatic and Renal Impairment on Lemborexant Pharmacokinetics Figure 2. Effects of Co-administered Drugs on the Pharmacokinetics of Lemborexant 10 mg Figure 3. Effects of Lemborexant 10 mg on the Pharmacokinetics of Co-Administered Drugs

12.1Mechanism of Action The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

12.2Pharmacodynamics Lemborexant binds to orexin receptors OX1R and OX2R and acts as a competitive antagonist (IC 50 values of 6.1 nM and 2.6 nM, respectively). A major metabolite of lemborexant, M10, binds with comparable affinity as the parent drug to orexin receptors OX1R and OX2R (IC 50 values of 4.2 nM and 2.9 nM), respectively. Cardiac Electrophysiology In a concentration-QTcF analysis using the data from two randomized, double-blind, placebo-controlled, multiple ascending dose studies in healthy subjects, lemborexant does not prolong the QTcF interval to any clinically relevant extent at a dose 5 times the maximum recommended dose.

Drug Interactions Lemborexant co-administered with alcohol produced a numerically greater negative impact on postural stability and memory as compared with alcohol alone at approximately 2 hours post-dose [see Drug Interactions 7.1 ].

12.3Pharmacokinetics Following single doses of lemborexant 2.5 to 75 mg, geometric mean C max and AUC 0-24h increased slightly less than in proportion to dose. The extent of accumulation of lemborexant at steady-state is 1.5- to 3-fold across this dose range. Absorption The time to peak concentration (t max ) of lemborexant is approximately 1 to 3 hours.

Effect of Food Lemborexant C max decreased by 23%, AUC 0-inf increased by 18%, and t max was delayed by 2 hours following administration of a high-fat and high-calorie meal (containing approximately 150, 250, and 500 to 600 calories from protein, carbohydrate, and fat, respectively). Distribution The volume of distribution of lemborexant is 1970 L. Plasma protein binding of lemborexant is approximately 88% in vitro and 94% in clinical samples.

The blood to plasma concentration ratio of lemborexant is 0.65. Elimination Metabolism Lemborexant is primarily metabolized by CYP3A4, and to a lesser extent by CYP3A5. The major circulating metabolite is M10.

Excretion Following administration of an oral dose, 57.4% of the dose was recovered in the feces and 29.1% in the urine (<1% as unchanged). The effective half-life for lemborexant 5 mg and 10 mg is 17 and 19 hours, respectively. Specific Populations No clinically significant differences in the pharmacokinetics of lemborexant were observed based on age, sex, race/ethnicity, or body mass index.

No studies have been conducted to investigate the pharmacokinetics of lemborexant in pediatric patients. Exposures of lemborexant in patients with hepatic and renal impairment are summarized in Figure 1. Figure 1.

Effects of Hepatic and Renal Impairment on Lemborexant Pharmacokinetics Drug Interaction Studies The effects of other drugs on the exposures of lemborexant are summarized in Figure 2. The effects of lemborexant on the exposures of other drugs are summarized in Figure 3. Based on these results, drug interactions between lemborexant and strong CYP3A inducers, strong CYP3A inhibitors, moderate CYP3A inhibitors, and CYP2B6 substrates are clinically significant [see Dosage and Administration ( 2.2 ), Drug Interactions ( 7.1 )].

Physiologically-based pharmacokinetic (PBPK) modeling predicted that concomitant use of weak CYP3A inhibitors increased lemborexant exposure by less than 2-fold [see Dosage and Administration ( 2.2 ), Drug Interactions ( 7.1 )] , and that lemborexant is expected to have minimal effect on the pharmacokinetics of CYP2C8,…

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking the binding of wake-promoting neuropeptides orexin A and orexin B to receptors OX1R and OX2R is thought to suppress wake drive.

📦 How Supplied / Storage and Handling 193 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied DAYVIGO tablets are available as: 5 mg, pale yellow, round, biconvex, film-coated tablets, and debossed with "5" on one side and "LЄM" on the other side. NDC 62856-405-30, bottle of 30 with child-resistant closure NDC 62856-405-90, bottle of 90 with child-resistant closure 10 mg, orange, round, biconvex, film-coated tablets, and debossed with "10" on one side and "LЄM" on the other side. NDC 62856-410-30, bottle of 30 with child-resistant closure NDC 62856-410-90, bottle of 90 with child-resistant closure

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].

16.1How Supplied DAYVIGO tablets are available as: 5 mg, pale yellow, round, biconvex, film-coated tablets, and debossed with "5" on one side and "LЄM" on the other side. NDC 62856-405-30, bottle of 30 with child-resistant closure NDC 62856-405-90, bottle of 90 with child-resistant closure 10 mg, orange, round, biconvex, film-coated tablets, and debossed with "10" on one side and "LЄM" on the other side. NDC 62856-410-30, bottle of 30 with child-resistant closure NDC 62856-410-90, bottle of 90 with child-resistant closure

📦 Storage and Handling 26 words ▾

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].

📋 Description 162 words ▾

11 DESCRIPTION DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)- N -(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C 22 H 20 F 2 N 4 O 2 .

The molecular weight is 410.42. The structural formula is: Lemborexant is a white to off-white powder that is practically insoluble in water. DAYVIGO tablets are intended for oral administration.

Each film coated tablet contains 5 mg or 10 mg of lemborexant. The inactive ingredients are: hydroxypropyl cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose 2910, polyethylene glycol 8000, talc, titanium dioxide, and either (a) ferric oxide yellow for the 5 mg tablet; or, (b) both ferric oxide yellow and ferric oxide red for the 10 mg tablet.

The structural formula for DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)-2-{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl) cyclopropanecarboxamide. The molecular formula is C22H20F2N4O2.

The molecular weight is 410.42.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Administration Instructions Advise patients to take DAYVIGO only when preparing for or getting into bed and only if they can stay in bed for a full night (at least 7 hours) before being active again [see Dosage and Administration ( 2.1 ) ] . Advise patients that the effect of DAYVIGO may be delayed if taken with or soon after a meal [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 )] .

CNS Depressant Effects and Daytime Impairment Advise patients that DAYVIGO can impair daytime wakefulness even when used as prescribed. The risk of daytime impairment is increased if DAYVIGO is taken with less than a full night of sleep remaining or if a higher than recommended dose is taken. If DAYVIGO is taken in these circumstances, caution patients against driving and other activities requiring complete mental alertness.

Advise patients that increased drowsiness may increase the risk of falls in some patients [see Warnings and Precautions ( 5.1 )]. Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-Like Symptoms Advise patients and their families that DAYVIGO may cause sleep paralysis, which is an inability to move or speak for several minutes during sleep-wake transitions, despite being aware of surroundings; hypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions; and symptoms similar to mild cataplexy [see Warnings and Precautions ( 5.2 )].

Complex Sleep Behaviors Instruct patients and their families that DAYVIGO may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Tell patients to discontinue DAYVIGO and notify their healthcare provider immediately if they develop any of these symptoms [see Warnings and Precautions ( 5.3 )]. Worsening of Depression/Suicidal Ideation Tell patients to report any worsening of depression or suicidal thoughts immediately [see Warnings and Precautions ( 5.4 )].

Pregnancy Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DAYVIGO during pregnancy [see Use in Specific Populations ( 8.1 )]. Concomitant Medications Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to consume alcohol in combination with DAYVIGO [see Drug Interactions ( 7.1 ), Clinical Pharmacology ( 12.3 )].

Tolerance, Abuse, and Dependence Tell patients not to increase the dose of DAYVIGO on their own, and to inform you if they believe the drug “does not work” [see Drug Abuse and Dependence ( 9 )]. Distributed by: Eisai Inc. Nutley, NJ 07110 DAYVIGO ® is a registered trademark of Eisai R&D Management Co., Ltd. and is licensed to Eisai Inc. © 2019-2025 Eisai Inc.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE DAYVIGO ® (daye-vi'-goe) (lemborexant) tablets, for oral use , CIV What is the most important information I should know about DAYVIGO? DAYVIGO may cause serious side effects including: Decreased awareness and alertness. The morning after you take DAYVIGO, your ability to drive safely and think clearly may be decreased.

You may also have sleepiness during the day. ○ Do not take more DAYVIGO than prescribed. ○ Do not take DAYVIGO unless you are able to stay in bed for a full night (at least 7 hours) before you must be active again. ○ Take DAYVIGO right before going to bed. See “What are the possible side effects of DAYVIGO?” for more information about side effects. What is DAYVIGO?

DAYVIGO is a prescription medicine for adults who have trouble falling or staying asleep (insomnia). It is not known if DAYVIGO is safe and effective in children under the age of 18 years. DAYVIGO is a federally controlled substance (CIV) because it can be abused or cause dependence.

Keep DAYVIGO in a safe place to prevent misuse and abuse. Selling or giving away DAYVIGO may harm others and is against the law. Tell your doctor if you have ever abused or have been dependent on alcohol, prescription medicines or street drugs.

Who should not take DAYVIGO? Do not take DAYVIGO if you fall asleep often at unexpected times (narcolepsy). Before taking DAYVIGO, tell your healthcare provider about all of your medical conditions, including if you: have a history of depression, mental illness, or suicidal thoughts. have a history of drug or alcohol abuse or addiction. have a history of a sudden onset of muscle weakness (cataplexy). have a history of daytime sleepiness. have lung problems or breathing problems. have liver problems. are pregnant or plan to become pregnant.

It is not known if DAYVIGO can harm your unborn baby. Pregnancy Registry : There is a pregnancy registry for women who are exposed to DAYVIGO during pregnancy or who become pregnant while taking DAYVIGO. The purpose of this registry is to collect information about the health of you and your baby.

For more information or to participate in the registry, call 1-866-961-2388 or go to https://womensmentalhealth.org/research/pregnancyregistry. Talk with your healthcare provider about the risk to your unborn baby if you take DAYVIGO during pregnancy. are breastfeeding or plan to breastfeed. DAYVIGO passes into your breastmilk.

Talk to your healthcare provider about the best way to feed your baby during treatment with DAYVIGO. Tell your healthcare provider about all of the medicines you take , including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking DAYVIGO with certain other medicines can cause serious side effects.

DAYVIGO may affect the way other medicines work and other medicines may affect the way DAYVIGO works. Do not take DAYVIGO with other medicines that can make you sleepy unless your healthcare provider tells you to. Know the medicines you take.

Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine. How should I take DAYVIGO? Take DAYVIGO exactly as your healthcare provider tells you to take it.

Only take DAYVIGO one time each night, right before going to bed. Only take DAYVIGO when you can stay in bed for a full night (at least 7 hours). DAYVIGO may take longer to work if you take it with or soon after a meal.

Do not increase your dose of DAYVIGO without talking to your healthcare provider first. Call your healthcare provider if your insomnia (sleep problem) worsens or is not improved within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

If you take too much DAYVIGO, call your healthcare provider or go to the nearest hospital emergency room right away. What should I avoid while taking DAYVIGO? Do not drink alcohol while taking DAYVIGO.

It can increase your chances of getting serious side effects. Do not drive , operate heavy machinery…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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