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BELSOMRA suvorexant 15 mg Tablet, Film Coated, 3-count — NDC 00006-0325-13 package photo

BELSOMRA suvorexant 15 mg Tablet, Film Coated, 3-count

by Merck Sharp & Dohme LLC · 1 BLISTER PACK in 1 CASE (0006-0325-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK
NDC 00006-0325-13
🏷️ FDA NDC (as labeled) 0006-0325-13 billing pads the labeler segment with a zero
This package
Contains3-count Pack sizes2 compare ↓
Also priced by: Part D plans $15.29/unit — full pricing hub ↓
Also comes in: 10 tablets 00006-0325-30
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

🚨
Active recall for this product.
Class II · Jul 21, 2025 — Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep. (Merck & Co. Inc) · FDA recall D-0584-2025
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0006-0325-13
Product NDC 0006-0325
11-digit billing NDC 00006032513
NCPDP billing unit EA — each (per item)
RxCUI 1547104, 1547110, 1547112, 1547114, 1547116, 1547118, 1547573, 1547575
UNII 081L192FO9
Application # NDA204569
SPL Set ID e5b72731-1acb-45b7-9c13-290ad12d3951
Established class (EPC) Orexin Receptor Antagonist
Mechanism of action Orexin Receptor Antagonists; P-Glycoprotein Inhibitors; Cytochrome P450 3A Inhibitors
DEA schedule CIV
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-08-29
Route ORAL
Dosage form TABLET, FILM COATED
Substance SUVOREXANT
GPI-14 60500070000315
GPI class Belsomra
GCN Seq No 072692
GCN 36969
HICL code 041333
Ingredient (HICL) Suvorexant
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 BELSOMRA 15 MG TABLET
FDB brand name Belsomra
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0006-0325-13 — a 4-4-2 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 labeler segment → 00006-0325-13. 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 P-Glycoprotein Inhibitors, Cytochrome P450 3A Inhibitors, 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

LabelerMerck Sharp & Dohme LLC
Application holderMERCK SHARP AND DOHME CORP
FDA applicationNDA204569 (NDA)
Labeler code00006
First marketedAug 2014
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio112 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 BELSOMRA 15 MG TABLET Ingredient Suvorexant
📗 Our plain-language guide HelloPharmacist
  • Belsomra works by blocking specific brain chemicals called orexins that keep you awake. Most older sleep medications broadly sedate the entire brain, but Belsomra targets the wake-...
  • What exactly does Belsomra do, and how is it different from other sleep aids?
  • Belsomra is intended for once-nightly use, and you should only take it when you have at least 7 full hours to sleep before you need to be up. It typically starts working within abo...
  • Can I take Belsomra every night, and how long does it take to work?
📖 Read our full Suvorexant 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 / Green / White
ShapeRound
Imprint335
Size8 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 D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • UNII M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

8 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 $15.29 $45.86 / 3 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
Belsomra 15 mgthis 00006-0325-13 Merck 3 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

🏛️
2014
First FDA approval
Aug 2014
📍
2026
Currently FDA-listed
12 years listed
🛡️
2033
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 May 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Aug 13, 2014 RLD RS ⏳ ~6.7 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 7951797 — drug substance (U-620)
US 7951797 — drug substance (U-620)
US 7951797 — drug substance (U-620)
US 7951797 — drug substance (U-620)
US 11980623 — drug product
US 10098892 — drug product
US 11980623 — drug product
US 12599610 — drug product
US 12599610 — drug product
US 11980623 — drug product
US 10098892 — drug product
US 11980623 — drug product
US 10098892 — drug product
US 12599610 — drug product
US 10098892 — drug product
US 12599610 — drug product
2014 2016 2018 2020 2022 2024 2026 2028 2030 2032
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 (16)
PatentTypeUse codeExpires
US 7951797 ↗ Drug substance U-620 Nov 20, 2029
US 7951797 ↗ Drug substance U-620 Nov 20, 2029
US 7951797 ↗ Drug substance U-620 Nov 20, 2029
US 7951797 ↗ Drug substance U-620 Nov 20, 2029
US 11980623 ↗ Drug product — May 29, 2033
US 10098892 ↗ Drug product — May 29, 2033
US 11980623 ↗ Drug product — May 29, 2033
US 12599610 ↗ Drug product — May 29, 2033
US 12599610 ↗ Drug product — May 29, 2033
US 11980623 ↗ Drug product — May 29, 2033
US 10098892 ↗ Drug product — May 29, 2033
US 11980623 ↗ Drug product — May 29, 2033
US 10098892 ↗ Drug product — May 29, 2033
US 12599610 ↗ Drug product — May 29, 2033
US 10098892 ↗ Drug product — May 29, 2033
US 12599610 ↗ Drug product — May 29, 2033
Common questions
Is there a generic version of BELSOMRA 15 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for BELSOMRA 15 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2033 — 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.
10 tablets00006-0325-30 6,061 Rx · $2,660,583
3 tablets this page00006-0325-13 No Medicaid data
Drug total (last 4 qtrs): 6,061 Rx · 176,908 units · $2,660,583 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 Belsomra — 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 Belsomra. 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
$38.93M
Claims incl. refills
75.6K
Beneficiaries
39.2K
Spend / beneficiary
$993.07
Spend / claim
$515.06
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 BELSOMRA (this brand).

Top reported reactions

Nightmare740
Somnolence731
Insomnia680
Abnormal Dreams602
Headache545
Feeling Abnormal489
Nausea387

Age at onset

Neonate3
Child5
Adolescent1
Adult678
Elderly568

Reporter sex

12,888 reports
Male · 39%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization2,028
Death696
Disabling218
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 714 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
00006-0325-13 You're viewing this 1 BLISTER PACK in 1 CASE (0006-0325-13) / 3 TABLET, FILM COATED in 1 BLISTER PACK — — 2014-08-29 Active
00006-0325-30 3 CASE in 1 CARTON (0006-0325-30) / 1 BLISTER PACK in 1 CASE (0006-0325-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK $15.20 / ea $455.96 2014-08-29 Active

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 00006-0325-13?
NDC 00006-0325-13 is a 3-count package — 1 blister pack in 1 case / 3 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of BELSOMRA suvorexant 15 mg Tablet, Film Coated?
Bill NDC 00006-0325-13 — the 11-digit billing format is 00006032513. 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 0006-0325-13, 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: 00006-0325-13, written without dashes as 00006032513. 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 00006-0325-13, the first segment (00006) is the labeler code FDA assigned to Merck Sharp & Dohme LLC; the middle segment (0325) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (13) 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 Merck Sharp & Dohme LLC. 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 1 other package presentation of this same product, including 10 tablets (00006-0325-30). 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?
Merck Sharp & Dohme LLC 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 47 words ▾

1 INDICATIONS AND USAGE BELSOMRA ® (suvorexant) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. BELSOMRA is an orexin receptor antagonist indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance ( 1 ).

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient ( 2.1 ). Recommended dose is 10 mg, no more than once per night taken within 30 minutes of going to bed, with at least 7 hours remaining before the planned time of awakening. If the 10 mg dose is well-tolerated but not effective, the dose can be increased, not to exceed 20 mg once daily ( 2.1 , 2.2 ). Time to effect may be delayed if taken with or soon after a meal ( 2.1 ).

2.1Dosing Information Use the lowest dose effective for the patient. For all BELSOMRA doses, take no more than once per night within 30 minutes of going to bed (with at least 7 hours remaining prior to planned awakening). Time to effect of BELSOMRA may be delayed if taken with or soon after a meal [see Clinical Pharmacology (12.3) ].

The recommended dose for BELSOMRA is 10 mg, taken no more than once per night. If the 10 mg dose is well-tolerated but not effective, the dose can be increased. The maximum recommended dose of BELSOMRA is 20 mg taken no more than once per night.

2.2Special Populations Exposure to BELSOMRA is increased in obese compared to non-obese patients, and in women compared to men. Particularly in obese women, the increased risk of exposure-related adverse effects should be considered before increasing the dose [see Clinical Pharmacology (12.3) ] .

2.3Use with CNS Depressants When BELSOMRA is combined with other CNS depressant drugs, dosage reduction of BELSOMRA and/or the other drug(s) may be necessary because of potentially additive effects [see Warnings and Precautions (5.1) ] .

2.4Dosage Adjustments with CYP3A Inhibitors When used with moderate CYP3A inhibitors, the recommended dosage of BELSOMRA is 5 mg taken no more than once per night (the dose generally should not exceed 10 mg). BELSOMRA is not recommended for use with strong CYP3A inhibitors [see Drug Interactions (7.2) ] .

💊 Dosage Forms and Strengths 99 words ▾

3 DOSAGE FORMS AND STRENGTHS 5 mg tablets are yellow, round, film-coated tablets with "5" on one side and plain on the other side. 10 mg tablets are green, round, film-coated tablets with "33" on one side and plain on the other side. 15 mg tablets are white, oval, film-coated tablets with the corporate logo on one side and "325" on the other side.

20 mg tablets are white, round, film-coated tablets with the corporate logo and "335" on one side and plain on the other side. Tablets, 5 mg, 10 mg, 15 mg, 20 mg ( 3 ).

⛔ Contraindications 19 words ▾

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

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS CNS Depressant Effects and Daytime Impairment: Risk of impaired alertness and motor coordination, including impaired driving; risk increases with dose; caution patients taking 20 mg against next-day driving and other activities requiring complete mental alertness ( 5.1 ). Worsening of Depression/Suicidal Ideation: Worsening of depression or suicidal thinking may occur. Risk increases with dose.

Immediately evaluate any new behavioral changes ( 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 ).

Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and Cataplexy-like Symptoms: May occur with the use of BELSOMRA. Risk increases with dose ( 5.4 ). Compromised Respiratory Function: Effect on respiratory function should be considered ( 5.5 , 8.6 ).

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 BELSOMRA is a central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed. Prescribers should monitor for somnolence and CNS depressant effects, but impairment can occur in the absence of symptoms, and may not be reliably detected by ordinary clinical exam (i.e., less than formal testing of daytime wakefulness and/or psychomotor performance). CNS depressant effects may persist in some patients for up to several days after discontinuing BELSOMRA.

BELSOMRA can impair driving skills and may increase the risk of falling asleep while driving. Discontinue or decrease the dose in patients who drive if daytime somnolence develops. In a study of healthy adults, driving ability was impaired in some individuals taking 20 mg BELSOMRA [see Clinical Studies (14.2) ].

Although pharmacodynamic tolerance or adaptation to some adverse depressant effects of BELSOMRA may develop with daily use, patients using the 20 mg dose of BELSOMRA should be cautioned against next-day driving and other activities requiring full mental alertness. Patients taking lower doses of BELSOMRA should also be cautioned about the potential for driving impairment because there is individual variation in sensitivity to BELSOMRA. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression.

Patients should be advised not to consume alcohol in combination with BELSOMRA because of additive effects [see Drug Interactions (7.1) ] . Dosage adjustments of BELSOMRA and of concomitant CNS depressants may be necessary when administered together because of potentially additive effects. The use of BELSOMRA with other drugs to treat insomnia is not recommended [see Dosage and Administration (2.3) ].

The risk of next-day impairment, including impaired driving, is increased if BELSOMRA is taken with less than a full night of sleep remaining, if a higher than the recommended dose is taken, if co-administered with other CNS depressants, or if co-administered with other drugs that increase blood levels of BELSOMRA. Patients should be cautioned against driving and other activities requiring complete mental alertness if BELSOMRA is taken in these circumstances. Because BELSOMRA can cause drowsiness, patients, particularly the elderly, are at higher risk of falls.

5.2Worsening of Depression/Suicidal Ideation In clinical studies, a dose-dependent increase in suicidal ideation was observed in patients taking BELSOMRA as assessed by questionnaire. Immediately evaluate patients with suicidal ideation or any new behavioral sign or symptom. In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides) have been reported.

Suicidal tendencies may be present in such patients and protect…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections: CNS Depressant Effects and Daytime Impairment [see Warnings and Precautions (5.1) ] Worsening of Depression/Suicidal Ideation [see Warnings and Precautions (5.2) ] Complex Sleep Behaviors [see Warnings and Precautions (5.3) ] Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms [see Warnings and Precautions (5.4) ] Patients with Compromised Respiratory Function [see Warnings and Precautions (5.5) ] The most common adverse reaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) with BELSOMRA was somnolence ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 clinical practice. In 3-month controlled efficacy trials (Study 1 and Study 2), 1263 patients were exposed to BELSOMRA including 493 patients who received BELSOMRA 15 mg or 20 mg (see Table 1 ). In a long-term study, additional patients (n=521) were treated with BELSOMRA at higher than recommended doses, including a total of 160 patients who received BELSOMRA for at least one year.

Table 1: Patient Exposure to BELSOMRA 15 mg or 20 mg in Study 1 and Study 2 Patients Treated BELSOMRA 15 mg BELSOMRA 20 mg For ≥ 1 Day (n) 202 291 Men (n) 69 105 Women (n) 133 186 Mean Age (years) 70 45 For ≥ 3 Months (n) 118 172 The pooled safety data described below (see Table 2 ) reflect the adverse reaction profile during the first 3 months of treatment. Adverse Reactions Resulting in Discontinuation of Treatment The incidence of discontinuation due to adverse reactions for patients treated with 15 mg or 20 mg of BELSOMRA was 3% compared to 5% for placebo.

No individual adverse reaction led to discontinuation at an incidence ≥1%. Most Common Adverse Reactions In clinical trials of patients with insomnia treated with BELSOMRA 15 mg or 20 mg, the most common adverse reaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) was somnolence (BELSOMRA 7%; placebo 3%). Table 2 shows the percentage of patients with adverse reactions during the first three months of treatment, based on the pooled data from 3-month controlled efficacy trials (Study 1 and Study 2).

At doses of 15 or 20 mg, the incidence of somnolence was higher in females (8%) than in males (3%). Of the adverse reactions reported in Table 2, the following occurred in women at an incidence of at least twice that in men: headache, abnormal dreams, dry mouth, cough, and upper respiratory tract infection. The adverse reaction profile in elderly patients was generally consistent with non-elderly patients.

The adverse reactions reported during long-term treatment up to 1 year were generally consistent with those observed during the first 3 months of treatment. Table 2: Percentage of Patients with Adverse Reactions Incidence ≥2% and Greater than Placebo in 3-Month Controlled Efficacy Trials (Study 1 and Study 2) Placebo BELSOMRA (20 mg in non-elderly or 15 mg in elderly patients) n=767 n=493 Gastrointestinal Disorders Diarrhea 1 2 Dry mouth 1 2 Infections and Infestations Upper respiratory tract infection 1 2 Nervous System Disorders Headache 6 7 Somnolence 3 7 Dizziness 2 3 Psychiatric Disorders Abnormal dreams 1 2 Respiratory, Thoracic and Mediastinal Disorders Cough 1 2 Dose Relationship for Adverse Reactions There is evidence of a dose relationship for many of the adverse reactions associated with BELSOMRA use, particularly for certain CNS adverse reactions.

In a placebo-controlled crossover study (Study 3), non-elderly adult patients were…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS CYP3A inhibitors: Recommended dose is 5 mg when used with moderate CYP3A inhibitors. Dose can be increased to 10 mg once per night if the 5 mg dose is not effective. Not recommended for use in patients taking strong CYP3A inhibitors ( 2.4 , 7.2 ). Strong CYP3A inducers: Efficacy may be reduced ( 7.2 ). Digoxin: Monitor digoxin concentrations ( 7.3 ).

7.1CNS-Active Agents When BELSOMRA was co-administered with alcohol, additive psychomotor impairment was demonstrated. There was no alteration in the pharmacokinetics of BELSOMRA [see Warnings and Precautions (5.1 , 5.3) and Clinical Pharmacology (12.3) ].

7.2Effects of Other Drugs on BELSOMRA Metabolism by CYP3A is the major elimination pathway for suvorexant. CYP3A Inhibitors Concomitant use of BELSOMRA with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan) is not recommended [see Clinical Pharmacology (12.3) ]. The recommended dose of BELSOMRA is 5 mg in subjects receiving moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil).

The dose generally should not exceed 10 mg in patients receiving moderate CYP3A inhibitors [see Clinical Pharmacology (12.3) ]. CYP3A Inducers Suvorexant exposure can be substantially decreased when co-administered with strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin). The efficacy of BELSOMRA may be reduced [see Clinical Pharmacology (12.3) ].

7.3Effects of BELSOMRA on Other Drugs Digoxin Concomitant administration of BELSOMRA with digoxin slightly increased digoxin levels due to inhibition of intestinal P-gp. Digoxin concentrations should be monitored when co-administering BELSOMRA with digoxin [see Clinical Pharmacology (12.3) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Patients with severe hepatic impairment: Not recommended ( 8.7 ).

8.1Pregnancy Risk Summary Available data from postmarketing reports with BELSOMRA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of suvorexant to pregnant rats and rabbits during the period of organogenesis decreased maternal body weight and/or weight gain at doses ≥ 30 and 28 times the maximum recommended human dose (MRHD) of 20 mg based on AUC in the rat and rabbit, respectively.

Suvorexant caused decreased fetal weight at doses ≥ 86 times the MRHD based on AUC in the rat and did not cause significant fetal toxicity at doses up to 28 times the MRHD based on AUC in the rabbit. The no observed adverse effect levels (NOAELs) for fetal toxicity are 25 and 28 times the MRHD based on AUC in the rat and rabbit, respectively. Oral administration of suvorexant to pregnant rats during pregnancy and lactation caused decreased maternal and pup body weight or weight gain at approximately 48 times the MRHD based on AUC.

The NOAEL for development toxicity in the rat is 25 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 US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Suvorexant was administered orally to pregnant rats during the period of organogenesis in two separate studies at doses of 30, 150, and 1000 mg/kg/day or 30, 80, and 325 mg/kg/day, which are approximately 3 to 93 times the MRHD based on AUC. Suvorexant decreased maternal weights at doses ≥ 150 mg/kg/day and fetal weights at doses ≥ 325 mg/kg/day.

The NOAEL for both maternal and fetal toxicity is 80 mg/kg/day, which is approximately 25 times the MRHD based on AUC. Suvorexant was administered orally to pregnant rabbits during the period of organogenesis in two separate studies at doses of 40, 100, and 300 mg/kg/day or 50, 150, and 325 mg/kg/day, which are approximately 3 to 70 times the MRHD based on AUC. Suvorexant decreased maternal body weight or weight gain at doses ≥ 150 mg/kg/day.

Suvorexant caused excessive maternal toxicity that led to premature deaths at 325 mg/kg/day, which precluded fetal evaluation. Suvorexant did not cause significant fetal toxicity at doses up to 300 mg/kg/day. The NOAELs for maternal and fetal toxicities are 100 mg/kg/day and 300 mg/kg/day, respectively, which are approximately 10 and 28 times the MRHD based on AUC, respectively.

Suvorexant was administered orally to pregnant rats during pregnancy and lactation at doses of 30, 80, and 200 mg/kg/day, which are approximately 8 to 48 times the MRHD based on AUC. Suvorexant caused maternal toxicity of decreased body weight and weight gain and food consumption at 200 mg/kg/day. At this maternally toxic dose, suvorexant caused decreased weight gain in offspring pups.

The NOAEL for maternal and developmental toxicity is 80 mg/kg/day, which is approximately 25 times the MRHD based on AUC.

8.2Lactation Risk Summary Suvorexant and its metabolite, hydroxy suvorexant, are present in low concentrations in breast milk with a relative infant dose of less than 1% following maternal oral administration (see Data ) . There are no data on the effects of suvorexant on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BELSOMRA and any potential adverse effects on the breastfed infant from BELSOMRA or from the underlying maternal condition.

Data A single dose (20 mg) milk and plasma lactation study was conducted in 12…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from postmarketing reports with BELSOMRA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of suvorexant to pregnant rats and rabbits during the period of organogenesis decreased maternal body weight and/or weight gain at doses ≥ 30 and 28 times the maximum recommended human dose (MRHD) of 20 mg based on AUC in the rat and rabbit, respectively.

Suvorexant caused decreased fetal weight at doses ≥ 86 times the MRHD based on AUC in the rat and did not cause significant fetal toxicity at doses up to 28 times the MRHD based on AUC in the rabbit. The no observed adverse effect levels (NOAELs) for fetal toxicity are 25 and 28 times the MRHD based on AUC in the rat and rabbit, respectively. Oral administration of suvorexant to pregnant rats during pregnancy and lactation caused decreased maternal and pup body weight or weight gain at approximately 48 times the MRHD based on AUC.

The NOAEL for development toxicity in the rat is 25 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 US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Suvorexant was administered orally to pregnant rats during the period of organogenesis in two separate studies at doses of 30, 150, and 1000 mg/kg/day or 30, 80, and 325 mg/kg/day, which are approximately 3 to 93 times the MRHD based on AUC. Suvorexant decreased maternal weights at doses ≥ 150 mg/kg/day and fetal weights at doses ≥ 325 mg/kg/day.

The NOAEL for both maternal and fetal toxicity is 80 mg/kg/day, which is approximately 25 times the MRHD based on AUC. Suvorexant was administered orally to pregnant rabbits during the period of organogenesis in two separate studies at doses of 40, 100, and 300 mg/kg/day or 50, 150, and 325 mg/kg/day, which are approximately 3 to 70 times the MRHD based on AUC. Suvorexant decreased maternal body weight or weight gain at doses ≥ 150 mg/kg/day.

Suvorexant caused excessive maternal toxicity that led to premature deaths at 325 mg/kg/day, which precluded fetal evaluation. Suvorexant did not cause significant fetal toxicity at doses up to 300 mg/kg/day. The NOAELs for maternal and fetal toxicities are 100 mg/kg/day and 300 mg/kg/day, respectively, which are approximately 10 and 28 times the MRHD based on AUC, respectively.

Suvorexant was administered orally to pregnant rats during pregnancy and lactation at doses of 30, 80, and 200 mg/kg/day, which are approximately 8 to 48 times the MRHD based on AUC. Suvorexant caused maternal toxicity of decreased body weight and weight gain and food consumption at 200 mg/kg/day. At this maternally toxic dose, suvorexant caused decreased weight gain in offspring pups.

The NOAEL for maternal and developmental toxicity is 80 mg/kg/day, which is approximately 25 times the MRHD based on AUC.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 88 words ▾

8.5Geriatric Use Of the total number of patients treated with BELSOMRA (n=1784) in controlled clinical safety and efficacy studies, 829 patients were 65 years and over, and 159 patients were 75 years and over. No clinically meaningful differences in safety or effectiveness were observed between these patients and younger patients at the recommended doses [see Clinical Pharmacology (12.3) and Clinical Studies (14) ] . Because BELSOMRA can increase drowsiness, patients, particularly the elderly, are at a higher risk of falls [see Warnings and Precautions (5.1) ] .

🆘 Overdosage 141 words ▾

10 OVERDOSAGE There is limited premarketing clinical experience with an overdosage of BELSOMRA. In clinical pharmacology studies, healthy subjects who were administered morning doses of up to 240 mg of suvorexant showed dose-dependent increases in the frequency and duration of somnolence. General symptomatic and supportive measures should be used, along with immediate gastric lavage where appropriate.

Intravenous fluids should be administered as needed. As in all cases of drug overdose, vital signs should be monitored and general supportive measures employed. The value of dialysis in the treatment of overdosage has not been determined.

As suvorexant is highly protein-bound, hemodialysis is not expected to contribute to elimination of suvorexant. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered. Consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of suvorexant 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 Suvorexant binds to orexin receptors, OX1R and OX2R (Ki= 0.55 and 0.35 nM, respectively). Antagonism of orexin receptors may also underlie potential adverse effects such as signs of narcolepsy/cataplexy. Genetic mutations in the orexin system in animals result in hereditary narcolepsy; loss of orexin neurons has been reported in humans with narcolepsy.

Evaluation of QTc Interval The effects of suvorexant on the QTc interval were evaluated in a randomized, placebo-, and active-controlled (moxifloxacin 400 mg) crossover study in healthy subjects (n=53). The upper bound of the one-sided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTc interval was below 10 ms based on analysis of suvorexant doses up to 240 mg, 12 times the maximum recommended dose. BELSOMRA thus does not prolong the QTc interval to any clinically relevant extent.

12.3Pharmacokinetics Suvorexant exposure increases in a less than strictly dose-proportional manner over the range of 10-80 mg because of decreased absorption at higher doses. Suvorexant pharmacokinetics are similar in healthy subjects and patients with insomnia. Absorption Suvorexant peak concentrations occur at a median T max of 2 hours (range 30 minutes to 6 hours) under fasted conditions.

The mean absolute bioavailability of 10 mg is 82%. Effect of Food Ingestion of BELSOMRA with a high-fat meal resulted in no meaningful change in AUC or C max but a delay in T max of approximately 1.5 hours [see Dosage and Administration (2.1) ] . Distribution The mean volume of distribution of suvorexant is approximately 49 liters.

Suvorexant is extensively bound (>99%) to human plasma proteins and does not preferentially distribute into red blood cells. Suvorexant binds to both human serum albumin and α1-acid glycoprotein. Elimination Metabolism Suvorexant is mainly eliminated by metabolism, primarily by CYP3A with a minor contribution from CYP2C19.

The major circulating entities are suvorexant and a hydroxy-suvorexant metabolite. This metabolite is not expected to be pharmacologically active. Excretion The primary route of elimination is through the feces, with approximately 66% of radiolabeled dose recovered in the feces compared to 23% in the urine.

The systemic pharmacokinetics of suvorexant are linear with an accumulation of approximately 1- to 2-fold with once-daily dosing. Steady-state is achieved by 3 days. The mean t 1/2 is approximately 12 hours (95% CI: 12 to 13).

Specific Populations Gender, age, body mass index (BMI), and race were included as factors assessed in the population pharmacokinetic model to evaluate suvorexant pharmacokinetics in healthy subjects and to predict exposures in the patient population. Age and race are not predicted to have any clinically meaningful changes on suvorexant pharmacokinetics; therefore, no dose adjustment is warranted based upon these factors. Suvorexant exposure is higher in females than in males.

In females, the AUC and C max are increased by 17% and 9%, respectively, following administration of BELSOMRA 40 mg. The average concentration of suvorexant 9 hours after dosing is 5% higher for females across the dose range studied (10-40 mg). Dose adjustment of BELSOMRA is generally not needed based on gender only.

Apparent oral clearance of suvorexant is inversely related to body mass index. In obese patients, the AUC and C max are increased by 31% and 17%, respectively. The average concentration of suvorexant approximately 9 hours after a 20 mg dose is 15% higher in obese patients (BMI > 30 kg/m 2 ) relative to those with a normal BMI (BMI…

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action The mechanism of action of suvorexant 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 177 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied BELSOMRA tablets, 5 mg, are yellow, round, film-coated tablets, with "5" on one side and plain on the other side. They are supplied as follows: NDC 0006-0005-30 unit-of-use blisters of 30 BELSOMRA tablets, 10 mg, are green, round, film-coated tablets, with "33" on one side and plain on the other side. They are supplied as follows: NDC 0006-0033-30 unit-of-use blisters of 30 BELSOMRA tablets, 15 mg, are white, oval, film-coated tablets with the corporate logo on one side and "325" on the other side.

They are supplied as follows: NDC 0006-0325-30 unit-of-use blisters of 30 BELSOMRA tablets, 20 mg, are white, round, film-coated tablets with the corporate logo and "335" on one side and plain on the other side. They are supplied as follows: NDC 0006-0335-30 unit-of-use blisters of 30

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), [see USP Controlled Room Temperature]. Store in the original package until use to protect from light and moisture.

📦 Storage and Handling 39 words ▾

16.2Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F), [see USP Controlled Room Temperature]. Store in the original package until use to protect from light and moisture.

📋 Description 143 words ▾

11 DESCRIPTION BELSOMRA tablets contain suvorexant, an orexin receptor antagonist. Suvorexant is described chemically as: [(7R)-4-(5-chloro-2-benzoxazolyl) hexahydro-7-methyl-1H-1,4-diazepin-1-yl][5-methyl-2-(2H-1,2,3-triazol-2-yl)phenyl]methanone Its empirical formula is C 23 H 23 ClN 6 O 2 and the molecular weight is 450.92. Its structural formula is: Suvorexant is a white to off-white powder that is insoluble in water.

Each film coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of suvorexant and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and polyvinylpyrrolidone/vinyl acetate copolymer (copovidone). In addition, the film coating contains the following inactive ingredients: hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The film coating for the 5 mg tablets also contains iron oxide black and iron oxide yellow, and the film coating for the 10 mg tablets also contains FD&C Blue #1/Brilliant Blue FCF Aluminum Lake and iron oxide yellow.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). CNS Depressant Effects and Next-Day Impairment Tell patients that BELSOMRA has the potential to cause next-day impairment, and that this risk is increased with higher doses or if dosing instructions are not carefully followed. Patients using the 20 mg dose should be cautioned against next-day driving and other activities requiring full mental alertness as this dose is associated with a higher risk of impaired driving.

Patients taking lower doses should also be cautioned about the potential for driving impairment because there is individual variation in sensitivity to BELSOMRA. Patients should not drive or engage in other activities requiring full alertness within 8 hours of dosing of BELSOMRA. Advise patients that increased drowsiness may increase the risk of falls in some patients [see Warnings and Precautions (5.1) ] .

Sleep-Driving and Other Complex Behaviors Instruct patients to inform their families that BELSOMRA has been associated with getting out of bed while not being fully awake, and tell patients and their families to call their healthcare providers if this occurs. Hypnotics, like BELSOMRA, have been associated with "sleep-driving" and other complex behaviors while not being fully awake (preparing and eating food, making phone calls, or having sex). Tell patients and their families to call their healthcare providers if they develop any of these symptoms.

Suicide Tell patients to report any worsening of depression or suicidal thoughts immediately. Alcohol and Other Drugs Ask patients about alcohol consumption, prescription medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use BELSOMRA if they drank alcohol that evening or before bed.

Tolerance, Abuse, and Dependence Tell patients not to increase the dose of BELSOMRA on their own, and to inform you if they believe the drug "does not work." Administration Instructions Advise patients to take BELSOMRA only when preparing for or getting into bed and only if they can stay in bed for a full night before being active again. Advise patients to report all of their prescription and nonprescription medicines, vitamins and herbal supplements to the prescriber.

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 3/2025 MEDICATION GUIDE BELSOMRA ® (bell-SOM-rah) suvorexant Tablets C-IV What is the most important information I should know about BELSOMRA?

BELSOMRA may cause serious side effects including: Decreased awareness and alertness. The morning after you take BELSOMRA, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.

Do not take more BELSOMRA than prescribed. Do not take BELSOMRA unless you are able to stay in bed a full night (at least 7 hours) before you must be active again. Take BELSOMRA within 30 minutes of going to bed.

See " What are the possible side effects of BELSOMRA? " for more information about side effects. What is BELSOMRA? BELSOMRA is a prescription medicine for adults who have trouble falling or staying asleep (insomnia).

It is not known if BELSOMRA is safe and effective in children under the age of 18. BELSOMRA is a federally controlled substance (C-IV) because it can be abused or cause dependence. Keep BELSOMRA in a safe place to prevent misuse and abuse.

Selling or giving away BELSOMRA 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 BELSOMRA?

Do not take BELSOMRA if you fall asleep often at unexpected times (narcolepsy). What should I tell my doctor before taking BELSOMRA? Before taking BELSOMRA, tell your doctor 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 falling asleep often at unexpected times (narcolepsy) or daytime sleepiness have lung problems or breathing problems have liver problems are pregnant or plan to become pregnant.

It is not known if BELSOMRA can harm your unborn baby. Talk to your healthcare provider about the risk to your unborn baby if you take BELSOMRA during pregnancy. are breastfeeding or plan to breastfeed. BELSOMRA passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby during treatment with BELSOMRA. Tell your doctor about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Medicines can interact with each other, sometimes causing serious side effects.

Do not take BELSOMRA with other medicines that can make you sleepy unless your doctor tells you to. Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

How should I take BELSOMRA? Take BELSOMRA exactly as your doctor tells you to take it. Only take BELSOMRA 1 time each night, if needed, within 30 minutes of going to bed.

Only take BELSOMRA when you can get a full night's sleep (at least 7 hours). Do not take BELSOMRA if you drank alcohol that evening or before bed. BELSOMRA may be taken with or without a meal.

However, BELSOMRA may take longer to work if you take it with or right after meals. Call your doctor if your insomnia (sleep problem) worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

If you take too much BELSOMRA, call your doctor right away or get emergency treatment. What should I avoid while taking BELSOMRA? Do not drink alcohol while taking BELSOMRA.

It can increase your chances of getting serious side effects. Do not drive, operate heavy machinery, do anything dangerous or do other activities that require clear thinking after taking BELSOMRA. You may still feel drowsy the next day after taking BELSOMRA.

Do not drive or do other dangerous activities until you feel fully awake. What are the possible side effects of BELSOMRA? See " What is the most important information I should know abou…

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