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SUNOSI solriamfetol 75 mg Tablet, Film Coated — NDC 81968-0350-10 package photo

SUNOSI solriamfetol 75 mg Tablet, Film Coated

by Axsome Therapeutics, Inc. · 10 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07)
NDC 81968-0350-10
🏷️ FDA NDC (as labeled) 81968-350-10 billing pads the product segment with a zero
This package
Contains7 tablet, film coated in 1 blister pack Cost per ea$27.79 NADAC Per package$1,945.32 / 70 tablets Pack sizes3 compare ↓
Also priced by: Part D plans $31.65/unit — full pricing hub ↓
Also comes in: 7 tablets 81968-0350-07 30 tablets 81968-0350-01
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) 81968-350-10
Product NDC 81968-350
11-digit billing NDC 81968035010
NCPDP billing unit EA — each (per item)
RxCUI 2121756, 2121758, 2121764, 2173841
UNII 939U7C91AI
UPC 0381968350018, 0381968351015
Application # NDA211230
SPL Set ID 362f206b-73e7-4009-8c34-5a9df55679ab
Established class (EPC) Dopamine and Norepinephrine Reuptake Inhibitor
Mechanism of action Dopamine Uptake Inhibitors; Norepinephrine Uptake Inhibitors
DEA schedule CIV
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-06-18
Route ORAL
Dosage form TABLET, FILM COATED
Substance SOLRIAMFETOL
GPI-14 61370070200320
GCN Seq No 079597
GCN 46126
HICL code 045666
Ingredient (HICL) Solriamfetol Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H8
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 2)
HIC3 code H8Q
Therapeutic class — specific (HIC3) Narcolepsy And Sleep Disorder Therapy Agents
AHFS code 28:20.80.00
AHFS class Wakefulness-Promoting Agents
FDB label name SUNOSI 75 MG TABLET
FDB brand name Sunosi
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 81968-350-10 — 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 → 81968-0350-10. 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 Dopamine and Norepinephrine Reuptake Inhibitor class.

Pharmacologic class Dopamine and Norepinephrine Reuptake Inhibitor
Drug family (ATC) Centrally acting sympathomimetics
How it works Norepinephrine Uptake Inhibitors, Dopamine Uptake Inhibitors
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

LabelerAxsome Therapeutics, Inc.
Application holderAXSOME MALTA LTD
FDA applicationNDA211230 (NDA)
Labeler code81968
First marketedJun 2019
DEA scheduleCIV
Product typeHuman Prescription Drug
Portfolio7 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 SUNOSI 75 MG TABLET Ingredient Solriamfetol Hcl
📗 Our plain-language guide HelloPharmacist
  • Sunosi is designed to reduce the excessive sleepiness that comes with narcolepsy or sleep apnea — it helps you feel more awake and alert during the day. It's not a stimulant meant...
  • What exactly does Sunosi do — will it keep me awake all day?
  • No — Sunosi does not treat the blocked airway that causes obstructive sleep apnea. It only helps with the daytime sleepiness that results from it. Your CPAP or other OSA treatment...
  • Can I stop using my CPAP machine once I start Sunosi?
📖 Read our full Solriamfetol 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
ShapeOval
Imprint150
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.

  • 0.23 mg 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.
  • 2.75 mg UNII UKE75GEA7F
    Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
  • 0.5 mg 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.
  • 0.65 mg UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • 1.3 mg UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • 0.48 mg 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.
  • 0.58 mg 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.

7 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 eaPer package
Retail pharmacies payNADAC · weekly $27.790 $1,945.32 / 70 tablets
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 $31.65 $2,215.40 / 70 tablets
NADAC price history (per ea) — tap or hover for the price & month
May 2023 Jan 2024 $27.790 $26.217
▲ Up 6% over the last 2 months.
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
Sunosi 75 mgthis 81968-0350-10 Axsome 7 tablets $27.790 AB FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2019
First FDA approval
Jun 2019
📍
2026
Currently FDA-listed
7 years listed
🛡️
2042
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 17, 2019 AB TE-rated RLD RS ⏳ ~16.3 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 8440715 — method of use (U-2548)
US 9604917 — method of use (U-2548)
US 9604917 — method of use (U-2548)
US 8440715 — method of use (U-2548)
US 10351517 — method of use (U-2548)
US 10351517 — method of use (U-2548)
US 10512609 — method of use (U-2548)
US 10512609 — method of use (U-2548)
US 12209059 — method of use (U-2548)
US 12209059 — method of use (U-2548)
US 11560354 — method of use (U-3520)
US 11560354 — method of use (U-3520)
US 11160779 — method of use (U-3521)
US 11160779 — method of use (U-3521)
US 12064411 — method of use (U-3693)
US 12064411 — method of use (U-3693)
US 12390419 — method of use (U-2548)
US 12390419 — method of use (U-2548)
US 12090126 — method of use (U-3693)
US 12090126 — method of use (U-3693)
US 11753368 — method of use (U-2548)
US 11753368 — method of use (U-2548)
US 12384743 — drug substance (U-2548)
US 12384743 — drug substance (U-2548)
US 12263145 — method of use (U-3693)
US 11998639 — method of use (U-2548)
US 11998639 — method of use (U-2548)
US 11793776 — method of use (U-3693)
US 11793776 — method of use (U-3693)
US 12318362 — method of use (U-3765)
US 11969404 — method of use (U-3892)
US 12194016 — method of use (U-4106)
US 12194016 — method of use (U-4106)
US 10940133 — method of use (U-3099)
US 11771667 — method of use (U-3693)
US 11771667 — method of use (U-3693)
US 11771666 — method of use (U-3693)
US 11771666 — method of use (U-3693)
US 11779554 — method of use (U-3693)
US 11779554 — method of use (U-3693)
US 12036194 — method of use (U-3693)
US 12036194 — method of use (U-3693)
US 8877806 — method of use (U-2548)
US 8877806 — method of use (U-2548)
US 10912754 — method of use (U-3082)
US 10912754 — method of use (U-3082)
US 10959976 — method of use (U-3151)
US 10959976 — method of use (U-3151)
US 11648232 — method of use (U-3602)
US 11648232 — method of use (U-3602)
US 11865098 — method of use (U-2548)
US 11865098 — method of use (U-2548)
US 11839599 — method of use (U-3764)
US 11839599 — method of use (U-3764)
US 11839598 — method of use (U-3765)
US 11839598 — method of use (U-3765)
US 11850226 — method of use (U-3775)
US 11850226 — method of use (U-3775)
US 11850227 — method of use (U-3775)
US 11850227 — method of use (U-3775)
US 11850228 — method of use (U-3775)
US 11850228 — method of use (U-3775)
US 11857528 — method of use (U-3521)
US 11857528 — method of use (U-3521)
US 11872203 — method of use (U-3693)
US 11872203 — method of use (U-3693)
US 11872204 — method of use (U-3693)
US 11872204 — method of use (U-3693)
US 11986455 — method of use (U-3521)
US 11986455 — method of use (U-3521)
US 11986454 — method of use (U-3775)
US 11986454 — method of use (U-3775)
US 12005036 — method of use (U-3693)
US 12005036 — method of use (U-3693)
US 12102609 — method of use (U-3693)
US 12102609 — method of use (U-3693)
US 11969404 — method of use (U-3892)
US 11439597 — drug product
US 10195151 — drug product
US 11439597 — drug product
US 10195151 — drug product
Exclusivity ODE-254
Exclusivity ODE-254
2019 2021 2023 2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 (81)
PatentTypeUse codeExpires
US 8440715 ↗ Method of use U-2548 Jun 11, 2031
US 9604917 ↗ Method of use U-2548 Jun 7, 2026
US 9604917 ↗ Method of use U-2548 Jun 7, 2026
US 8440715 ↗ Method of use U-2548 Jun 11, 2031
US 10351517 ↗ Method of use U-2548 Jun 7, 2026
US 10351517 ↗ Method of use U-2548 Jun 7, 2026
US 10512609 ↗ Method of use U-2548 Sep 5, 2037
US 10512609 ↗ Method of use U-2548 Sep 5, 2037
US 12209059 ↗ Method of use U-2548 Jun 7, 2026
US 12209059 ↗ Method of use U-2548 Jun 7, 2026
US 11560354 ↗ Method of use U-3520 Mar 6, 2039
US 11560354 ↗ Method of use U-3520 Mar 6, 2039
US 11160779 ↗ Method of use U-3521 Mar 19, 2040
US 11160779 ↗ Method of use U-3521 Mar 19, 2040
US 12064411 ↗ Method of use U-3693 Dec 30, 2042
US 12064411 ↗ Method of use U-3693 Dec 30, 2042
US 12390419 ↗ Method of use U-2548 Sep 5, 2037
US 12390419 ↗ Method of use U-2548 Sep 5, 2037
US 12090126 ↗ Method of use U-3693 Dec 30, 2042
US 12090126 ↗ Method of use U-3693 Dec 30, 2042
US 11753368 ↗ Method of use U-2548 Jun 7, 2026
US 11753368 ↗ Method of use U-2548 Jun 7, 2026
US 12384743 ↗ Drug substance U-2548 Nov 1, 2038
US 12384743 ↗ Drug substance U-2548 Nov 1, 2038
US 12263145 ↗ Method of use U-3693 Dec 30, 2042
US 11998639 ↗ Method of use U-2548 Sep 5, 2037
US 11998639 ↗ Method of use U-2548 Sep 5, 2037
US 11793776 ↗ Method of use U-3693 Dec 30, 2042
US 11793776 ↗ Method of use U-3693 Dec 30, 2042
US 12318362 ↗ Method of use U-3765 Mar 19, 2040
US 11969404 ↗ Method of use U-3892 Mar 19, 2040
US 12194016 ↗ Method of use U-4106 Mar 19, 2040
US 12194016 ↗ Method of use U-4106 Mar 19, 2040
US 10940133 ↗ Method of use U-3099 Mar 19, 2040
US 11771667 ↗ Method of use U-3693 Dec 30, 2042
US 11771667 ↗ Method of use U-3693 Dec 30, 2042
US 11771666 ↗ Method of use U-3693 Dec 30, 2042
US 11771666 ↗ Method of use U-3693 Dec 30, 2042
US 11779554 ↗ Method of use U-3693 Dec 30, 2042
US 11779554 ↗ Method of use U-3693 Dec 30, 2042
US 12036194 ↗ Method of use U-3693 Dec 30, 2042
US 12036194 ↗ Method of use U-3693 Dec 30, 2042
US 8877806 ↗ Method of use U-2548 Jun 7, 2026
US 8877806 ↗ Method of use U-2548 Jun 7, 2026
US 10912754 ↗ Method of use U-3082 Jun 1, 2038
US 10912754 ↗ Method of use U-3082 Jun 1, 2038
US 10959976 ↗ Method of use U-3151 Jun 1, 2038
US 10959976 ↗ Method of use U-3151 Jun 1, 2038
US 11648232 ↗ Method of use U-3602 Jun 1, 2038
US 11648232 ↗ Method of use U-3602 Jun 1, 2038
US 11865098 ↗ Method of use U-2548 Jun 1, 2038
US 11865098 ↗ Method of use U-2548 Jun 1, 2038
US 11839599 ↗ Method of use U-3764 Mar 19, 2040
US 11839599 ↗ Method of use U-3764 Mar 19, 2040
US 11839598 ↗ Method of use U-3765 Mar 19, 2040
US 11839598 ↗ Method of use U-3765 Mar 19, 2040
US 11850226 ↗ Method of use U-3775 Mar 19, 2040
US 11850226 ↗ Method of use U-3775 Mar 19, 2040
US 11850227 ↗ Method of use U-3775 Mar 19, 2040
US 11850227 ↗ Method of use U-3775 Mar 19, 2040
US 11850228 ↗ Method of use U-3775 Mar 19, 2040
US 11850228 ↗ Method of use U-3775 Mar 19, 2040
US 11857528 ↗ Method of use U-3521 Mar 19, 2040
US 11857528 ↗ Method of use U-3521 Mar 19, 2040
US 11872203 ↗ Method of use U-3693 Dec 30, 2042
US 11872203 ↗ Method of use U-3693 Dec 30, 2042
US 11872204 ↗ Method of use U-3693 Dec 30, 2042
US 11872204 ↗ Method of use U-3693 Dec 30, 2042
US 11986455 ↗ Method of use U-3521 Mar 19, 2040
US 11986455 ↗ Method of use U-3521 Mar 19, 2040
US 11986454 ↗ Method of use U-3775 Mar 19, 2040
US 11986454 ↗ Method of use U-3775 Mar 19, 2040
US 12005036 ↗ Method of use U-3693 Dec 30, 2042
US 12005036 ↗ Method of use U-3693 Dec 30, 2042
US 12102609 ↗ Method of use U-3693 Dec 30, 2042
US 12102609 ↗ Method of use U-3693 Dec 30, 2042
US 11969404 ↗ Method of use U-3892 Mar 19, 2040
US 11439597 ↗ Drug product — Sep 5, 2037
US 10195151 ↗ Drug product — Sep 5, 2037
US 11439597 ↗ Drug product — Sep 5, 2037
US 10195151 ↗ Drug product — Sep 5, 2037
FDA exclusivity
CodeWhat it grantsExpires
ODE-254Orphan Drug Exclusivity (7-year)Jun 17, 2026
ODE-254Orphan Drug Exclusivity (7-year)Jun 17, 2026
Common questions
Is there a generic version of SUNOSI 75 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for SUNOSI 75 MG TABLET. See the alternatives section for substitutable, lower-cost products.
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 tablets81968-0350-01 3,362 Rx · $3,266,299
7 tablets this page81968-0350-10 No Medicaid data
7 tablets81968-0350-07 No Medicaid data
Drug total (last 4 qtrs): 3,362 Rx · 109,025 units · $3,266,299 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 Sunosi — 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 Sunosi. 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
$6.75M
Claims incl. refills
5.8K
Beneficiaries
2.9K
Spend / beneficiary
$2,331.44
Spend / claim
$1,170.97
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 Solriamfetol — the ingredient across all brands.

Top reported reactions

Anxiety335
Headache313
Nausea296
Fatigue266
Product Administration Interrupted266
Somnolence243
Surgery176

Age at onset

Neonate2
Infant6
Adolescent5
Adult443
Elderly68

Reporter sex

3,777 reports
Male · 26%
Female · 74%
Unknown · 0%

Serious outcomes

Hospitalization329
Disabling19
Life-threatening15
Death14
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 799 159
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
81968-0350-01 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (81968-350-01) $31.38 / ea $941.30 2022-06-02 Active
81968-0350-10 You're viewing this 10 BLISTER PACK in 1 CARTON (81968-350-10) / 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) $27.79 / ea $1,945.32 2022-06-02 Active
81968-0350-07 7 TABLET, FILM COATED in 1 BLISTER PACK (81968-350-07) $27.79 / ea $194.53 2022-06-02 Active

This pack has the lowest per-ea cost of the 3 priced pack sizes ($27.79 NADAC).

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 81968-0350-10?
NDC 81968-0350-10 is listed by the FDA — 10 blister pack in 1 carton / 7 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of SUNOSI solriamfetol 75 mg Tablet, Film Coated?
Bill NDC 81968-0350-10 — the 11-digit billing format is 81968035010. 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.

📄 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 196 words ▾

1 INDICATIONS AND USAGE SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies ( 14 )] . Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness.

Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities. SUNOSI is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

( 1 ) Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI.

SUNOSI is not a substitute for these modalities. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administer once daily upon awakening. Avoid administration within 9 hours of planned bedtime because of the potential to interfere with sleep. ( 2.2 ) Starting dose for patients with narcolepsy: 75 mg once daily.

( 2.3 ) Starting dose for patients with OSA: 37.5 mg once daily. ( 2.4 ) Dose may be increased at intervals of at least 3 days. ( 2.3 , 2.4 ) Maximum dose is 150 mg once daily.

( 2.3 , 2.4 ) Renal impairment ( 2.5 , 8.6 , 12.3 ): Moderate impairment: Starting dose is 37.5 mg once daily. May increase to 75 mg once daily after at least 7 days. Severe impairment: Starting dose and maximum dose is 37.5 mg once daily.

End stage renal disease (ESRD): Not recommended.

2.1Important Considerations Prior to Initiating Treatment Prior to initiating treatment with SUNOSI, ensure blood pressure is adequately controlled [see Warnings and Precautions ( 5.1 )] .

2.2General Administration Instructions Administer SUNOSI orally upon awakening with or without food. Avoid taking SUNOSI within 9 hours of planned bedtime because of the potential to interfere with sleep if taken too late in the day. SUNOSI 75 mg tablets are functionally scored tablets that can be split in half (37.5 mg) at the score line.

2.3Dosage in Narcolepsy Initiate SUNOSI at 75 mg once daily in adults with narcolepsy. The recommended dose range for SUNOSI is 75 mg to 150 mg once daily. Based on efficacy and tolerability, the dosage of SUNOSI may be doubled at intervals of at least 3 days.

The maximum recommended dose is 150 mg once daily. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions [see Warnings and Precautions ( 5.1 )] .

2.4Dosage in OSA Initiate SUNOSI at 37.5 mg once daily in adults with OSA. The recommended dosage range for SUNOSI is 37.5 mg to 150 mg once daily. Based on efficacy and tolerability, the dosage of SUNOSI may be doubled at intervals of at least 3 days.

The maximum recommended dosage is 150 mg once daily. Dosages above 150 mg daily do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions [see Warnings and Precautions ( 5.1 )] .

2.5Dosage Recommendations in Patients with Renal Impairment Moderate renal impairment (eGFR 30-59 mL/min/1.73 m 2 ) : Initiate dosing at 37.5 mg once daily. Based on efficacy and tolerability, dose may be increased to a maximum of 75 mg once daily after at least 7 days [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . Severe renal impairment (eGFR 15-29 mL/min/1.73 m 2 ) : Administer 37.5 mg once daily.

The maximum recommended daily dose is 37.5 mg [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] . End Stage Renal Disease (eGFR <15 mL/min/1.73 m 2 ) : SUNOSI is not recommended for use in patients with ESRD [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] .

💊 Dosage Forms and Strengths 74 words ▾

3 DOSAGE FORMS AND STRENGTHS SUNOSI 75 mg – (75 mg solriamfetol equivalent to 89.3 mg of the hydrochloride salt) dark yellow oblong tablet with "75" debossed on one side and a functional score line on the opposite side. SUNOSI 150 mg – (150 mg solriamfetol equivalent to 178.5 mg of the hydrochloride salt) yellow oblong tablet with "150" debossed on one side. Tablets: 75 mg (functionally scored) and 150 mg. ( 3 )

⛔ Contraindications 60 words ▾

4 CONTRAINDICATIONS SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of monoamine oxidase inhibitor, because of the risk of hypertensive reaction [see Drug Interactions ( 7.1 )] . Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Blood Pressure and Heart Rate Increases : Measure heart rate and blood pressure prior to initiating and periodically throughout treatment. Control hypertension before and during therapy. Avoid use in patients with unstable cardiovascular disease, serious heart arrhythmias, or other serious heart problems.

( 5.1 ) Psychiatric Symptoms : Use caution in treating patients with a history of psychosis or bipolar disorders. Consider dose reduction or discontinuation of SUNOSI if psychiatric symptoms develop. ( 5.2 )

5.1Blood Pressure and Heart Rate Increases SUNOSI increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion [see Adverse Reactions ( 6.1 )] . Epidemiological data show that chronic elevations in blood pressure increase the risk of major adverse cardiovascular events (MACE), including stroke, heart attack, and cardiovascular death. The magnitude of the increase in absolute risk is dependent on the increase in blood pressure and the underlying risk of MACE in the population being treated.

Many patients with narcolepsy and OSA have multiple risk factors for MACE, including hypertension, diabetes, hyperlipidemia, and high body mass index (BMI). Assess blood pressure and control hypertension before initiating treatment with SUNOSI. Monitor blood pressure regularly during treatment and treat new-onset hypertension and exacerbations of pre-existing hypertension.

Exercise caution when treating patients at higher risk of MACE, particularly patients with known cardiovascular and cerebrovascular disease, pre-existing hypertension, and patients with advanced age. Use caution with other drugs that increase blood pressure and heart rate [see Drug Interactions ( 7.2 )] . Periodically reassess the need for continued treatment with SUNOSI.

If a patient experiences increases in blood pressure or heart rate that cannot be managed with dose reduction of SUNOSI or other appropriate medical intervention, consider discontinuation of SUNOSI. Patients with moderate or severe renal impairment may be at a higher risk of increases in blood pressure and heart rate because of the prolonged half-life of SUNOSI [see Dosage and Administration ( 2.5 ), Clinical Pharmacology ( 12.3 )] .

5.2Psychiatric Symptoms Psychiatric adverse reactions have been observed in clinical trials with SUNOSI, including anxiety, insomnia, and irritability [see Adverse Reactions ( 6.1 )] . SUNOSI has not been evaluated in patients with psychosis or bipolar disorders. Exercise caution when treating patients with SUNOSI who have a history of psychosis or bipolar disorders.

Patients with moderate or severe renal impairment may be at a higher risk of psychiatric symptoms because of the prolonged half-life of SUNOSI [see Dosage and Administration ( 2.5 ), Clinical Pharmacology ( 12.3 )] . Patients treated with SUNOSI should be observed for the possible emergence or exacerbation of psychiatric symptoms. If psychiatric symptoms develop in association with the administration of SUNOSI, consider dose reduction or discontinuation of SUNOSI.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Blood Pressure and Heart Rate Increases [see Warnings and Precautions ( 5.1 )] Psychiatric Symptoms [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (≥ 5% and greater than placebo): headache, nausea, decreased appetite, insomnia, and anxiety. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics, Inc. at 1-800-484-1672 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 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 SUNOSI has been evaluated in 930 patients (ages 18 to 75 years) with narcolepsy or OSA. Among these patients, 396 were treated with SUNOSI in the 12-week placebo-controlled trials at doses of 37.5 mg (OSA only), 75 mg, and 150 mg once daily.

Information provided below is based on the pooled 12-week placebo-controlled studies in patients with narcolepsy or OSA. Most Common Adverse Reactions The most common adverse reactions (incidence ≥ 5% and greater than placebo) reported more frequently with the use of SUNOSI than placebo in either the narcolepsy or OSA populations were headache, nausea, decreased appetite, anxiety, and insomnia. Table 1 presents the adverse reactions that occurred at a rate of ≥ 2% and more frequently in SUNOSI-treated patients than in placebo-treated patients in the narcolepsy population.

Table 1: Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in Narcolepsy (75 mg and 150 mg) * “Insomnia” includes insomnia, initial insomnia, middle insomnia, and terminal insomnia. “Anxiety” includes anxiety, nervousness, and panic attack. “Headache” includes headache, tension headache, and head discomfort. “Nausea” includes nausea and vomiting. Narcolepsy System Organ Class Placebo N = 108 (%) SUNOSI N = 161 (%) Metabolism and Nutrition Disorders Decreased appetite 1 9 Psychiatric Disorders Insomnia* Anxiety* 4 1 5 6 Nervous System Disorders Headache* 7 16 Cardiac Disorders Palpitations 1 2 Gastrointestinal Disorders Nausea* Dry mouth Constipation 4 2 1 7 4 3 Table 2 presents the adverse reactions that occurred at a rate of ≥ 2% and more frequently in SUNOSI-treated patients than in placebo-treated patients in the OSA population.

Table 2: Adverse Reactions ≥ 2% in Patients Treated with SUNOSI and Greater than Placebo in Pooled 12-Week Placebo-Controlled Clinical Trials in OSA (37.5 mg, 75 mg, and 150 mg) * “Anxiety” includes anxiety, nervousness, and panic attack. “Nausea” includes nausea and vomiting. “Abdominal pain” includes abdominal pain, abdominal pain upper, and abdominal discomfort. OSA System Organ Class Placebo N = 118 (%) SUNOSI N = 235 (%) Metabolism and Nutrition Disorders Decreased appetite 1 6 Psychiatric Disorders Anxiety* Irritability 1 0 4 3 Nervous System Disorders Dizziness 1 2 Cardiac Disorders Palpitations 0 3 Gastrointestinal Disorders Nausea* Diarrhea Abdominal pain* Dry mouth 6 1 2 2 8 4 3 3 General Disorders and Administration Site Conditions Feeling jittery Chest discomfort 0 0 3 2 Skin and Subcutaneous Tissue Disorders Hyperhidrosis 0 2 Other Adverse Reactions Observed During the Premarketing Evaluation of SUNOSI Other adverse reactions of < 2% incidence but greater than placebo are shown below.

The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, or 4) which were not considered to have clinically significant implications. Narcolepsy population: Psychiatric disorders : agitation, bruxism, irritability Respiratory, thoracic and mediastinal d…

🔄 Drug Interactions 169 words ▾

7 DRUG INTERACTIONS Drugs that Increase Blood Pressure and/or Heart Rate and Dopaminergic Drugs : Use caution when co-administering with SUNOSI. ( 7.2 , 7.3 )

7.1Monoamine Oxidase (MAO) Inhibitors Do not administer SUNOSI concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. Concomitant use of MAO inhibitors and noradrenergic drugs may increase the risk of a hypertensive reaction. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure [see Contraindications ( 4 )].

7.2Drugs that Increase Blood Pressure and/or Heart Rate Concomitant use of SUNOSI with other drugs that increase blood pressure and/or heart rate has not been evaluated, and such combinations should be used with caution [see Warnings and Precautions ( 5.1 )].

7.3Dopaminergic Drugs Dopaminergic drugs that increase levels of dopamine or that bind directly to dopamine receptors might result in pharmacodynamic interactions with SUNOSI. Interactions with dopaminergic drugs have not been evaluated with SUNOSI. Use caution when concomitantly administering dopaminergic drugs with SUNOSI.

👥 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 exposed to SUNOSI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220 or contacting the company at www.SunosiPregnancyRegistry.com . Risk Summary Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproductive studies, oral administration of solriamfetol during organogenesis caused maternal and fetal toxicities in rats and rabbits at doses ≥ 4 and 5 times and was teratogenic at doses 19 and ≥ 5 times, respectively, the maximum recommended human dose (MRHD) of 150 mg based on mg/m 2 body surface area. Oral administration of solriamfetol to pregnant rats during pregnancy and lactation at doses ≥ 7 times the MRHD based on mg/m 2 body surface area resulted in maternal toxicity and adverse effects on fertility, growth, and development in offspring (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 Solriamfetol was administered orally to pregnant rats during the period of organogenesis at 15, 67, and 295 mg/kg/day, which are approximately 1, 4, and 19 times the MRHD based on mg/m 2 body surface area. Solriamfetol at ≥ 4 times the MRHD caused maternal toxicity that included hyperactivity, significant decreases in body weight, weight gain, and food consumption. Fetal toxicity at these maternally toxic doses included increased incidence of early resorption and post-implantation loss, and decreased fetal weight.

Solriamfetol was teratogenic at 19 times the MRHD; it increased the incidence of fetal malformations that included severe sternebrae mal-alignment, hindlimb rotation, bent limb bones, and situs inversus. This dose was also maternally toxic. The no-adverse-effect level for malformation is 4 times and for maternal and embryofetal toxicity is approximately 1 times the MRHD based on mg/m 2 body surface area.

Solriamfetol was administered orally to pregnant rabbits during the period of organogenesis at 17, 38, and 76 mg/kg/day, which are approximately 2, 5, and 10 times the MRHD based on mg/m 2 body surface area. Solriamfetol at 10 times the MRHD caused maternal toxicity of body weight loss and decreased food consumption. Solriamfetol was teratogenic at ≥ 5 times the MRHD, it caused fetal skeletal malformation (slight-to-moderate sternebrae mal-alignment) and decreased fetal weight.

The no-adverse-effect level for malformation and fetal toxicity is approximately 2 times and for maternal toxicity is approximately 5 times the MRHD based on mg/m 2 body surface area. Solriamfetol was administered orally to pregnant rats during the period of organogenesis from gestation day 7 through lactation day 20 post-partum, at 35, 110, and 350 mg/kg/day, which are approximately 2, 7, and 22 times the MRHD based on mg/m 2 body surface area. At ≥ 7 times the MRHD, solriamfetol caused maternal toxicity that included decreased body weight gain, decreased food consumption, and hyperpnea.

At these maternally toxic doses, fetal toxicity included increased incidence of stillbirth, postnatal pup mortality, and decreased pup weight. Developmental toxicity in offspring after lactation day 20 included decreased body weight, decreased weight gain, and delayed sexual maturation. Mating and fertility of offspring were decreased at maternal doses 22 times the MRHD without affecting learning and memory.

The no-adverse-effect level…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SUNOSI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220 or contacting the company at www.SunosiPregnancyRegistry.com . Risk Summary Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

In animal reproductive studies, oral administration of solriamfetol during organogenesis caused maternal and fetal toxicities in rats and rabbits at doses ≥ 4 and 5 times and was teratogenic at doses 19 and ≥ 5 times, respectively, the maximum recommended human dose (MRHD) of 150 mg based on mg/m 2 body surface area. Oral administration of solriamfetol to pregnant rats during pregnancy and lactation at doses ≥ 7 times the MRHD based on mg/m 2 body surface area resulted in maternal toxicity and adverse effects on fertility, growth, and development in offspring (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 Solriamfetol was administered orally to pregnant rats during the period of organogenesis at 15, 67, and 295 mg/kg/day, which are approximately 1, 4, and 19 times the MRHD based on mg/m 2 body surface area. Solriamfetol at ≥ 4 times the MRHD caused maternal toxicity that included hyperactivity, significant decreases in body weight, weight gain, and food consumption. Fetal toxicity at these maternally toxic doses included increased incidence of early resorption and post-implantation loss, and decreased fetal weight.

Solriamfetol was teratogenic at 19 times the MRHD; it increased the incidence of fetal malformations that included severe sternebrae mal-alignment, hindlimb rotation, bent limb bones, and situs inversus. This dose was also maternally toxic. The no-adverse-effect level for malformation is 4 times and for maternal and embryofetal toxicity is approximately 1 times the MRHD based on mg/m 2 body surface area.

Solriamfetol was administered orally to pregnant rabbits during the period of organogenesis at 17, 38, and 76 mg/kg/day, which are approximately 2, 5, and 10 times the MRHD based on mg/m 2 body surface area. Solriamfetol at 10 times the MRHD caused maternal toxicity of body weight loss and decreased food consumption. Solriamfetol was teratogenic at ≥ 5 times the MRHD, it caused fetal skeletal malformation (slight-to-moderate sternebrae mal-alignment) and decreased fetal weight.

The no-adverse-effect level for malformation and fetal toxicity is approximately 2 times and for maternal toxicity is approximately 5 times the MRHD based on mg/m 2 body surface area. Solriamfetol was administered orally to pregnant rats during the period of organogenesis from gestation day 7 through lactation day 20 post-partum, at 35, 110, and 350 mg/kg/day, which are approximately 2, 7, and 22 times the MRHD based on mg/m 2 body surface area. At ≥ 7 times the MRHD, solriamfetol caused maternal toxicity that included decreased body weight gain, decreased food consumption, and hyperpnea.

At these maternally toxic doses, fetal toxicity included increased incidence of stillbirth, postnatal pup mortality, and decreased pup weight. Developmental toxicity in offspring after lactation day 20 included decreased body weight, decreased weight gain, and delayed sexual maturation. Mating and fertility of offspring were decreased at maternal doses 22 times the MRHD without affecting learning and memory.

The no-adverse-effect level for maternal and developmenta…

🧒 Pediatric Use 24 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established. Clinical studies of SUNOSI in pediatric patients have not been conducted.

🧓 Geriatric Use 96 words ▾

8.5Geriatric Use Of the total number of patients in the narcolepsy and OSA clinical studies treated with SUNOSI, 13% (123/930) were 65 years of age or over. No clinically meaningful differences in safety or effectiveness were observed between elderly and younger patients. Solriamfetol is predominantly eliminated by the kidney.

Because elderly patients are more likely to have decreased renal function, dosing may need to be adjusted based on eGFR in these patients. Consideration should be given to the use of lower doses and close monitoring in this population [see Dosage and Administration ( 2.5 )].

🆘 Overdosage 49 words ▾

10 OVERDOSAGE A specific reversal agent for SUNOSI is not available. Hemodialysis removed approximately 21% of a 75 mg dose in end stage renal disease patients. Overdoses should be managed with primarily supportive care, including cardiovascular monitoring. Consult with a Certified Poison Control Center at 1-800-222-1222 for latest recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).

12.2Pharmacodynamics Solriamfetol binds to the dopamine transporter and norepinephrine transporter with low affinity (Ki=14.2 µM and 3.7 µM, respectively), and inhibits the reuptake of dopamine and norepinephrine with low potency (IC 50 =2.9 μM and 4.4 μM, respectively). Solriamfetol has no appreciable binding affinity for the serotonin transporter (Ki=81.5 µM) and does not inhibit serotonin reuptake (IC 50 > 100 μM). Solriamfetol has no appreciable binding affinity to dopamine, serotonin, norepinephrine, GABA, adenosine, histamine, orexin, benzodiazepine, muscarinic acetylcholine, or nicotinic acetylcholine receptors.

Cardiac Electrophysiology The effect of solriamfetol 300 mg and 900 mg (twice and six times the maximum recommended dose, respectively) on the QTc interval was evaluated in a randomized, double-blind, placebo-, and positive-controlled (moxifloxacin 400 mg), 4-period, crossover study in 60 healthy subjects. A large increase in heart rate was observed in both solriamfetol treatment groups (mean change from baseline in HR of 21 and 27 bpm in the 300 and 900 mg groups, respectively, compared with 8 bpm in the placebo group).

These heart rate effects impact the interpretability of the QTc effects, particularly in the 900 mg group. In this study, solriamfetol 300 mg did not prolong the QTcF interval to a clinically relevant extent.

12.3Pharmacokinetics Solriamfetol exhibits linear kinetics over the dose range of 42 to 1008 mg (approximately 0.28 to 6.7 times the maximum recommended dosage). Steady state is reached in 3 days, and once‑daily administration is expected to result in minimal accumulation (1.06 times single‑dose exposure). Absorption The oral bioavailability of solriamfetol is approximately 95%.

Peak plasma concentration of solriamfetol occurs at a median T max of 2 hours (range 1.25 to 3.0 hours) post-dose under fasted conditions. Effect of Food Ingestion of solriamfetol with a high-fat meal resulted in minimal change in C max and AUC inf ; however, a delay of approximately 1 hour in T max was observed. Distribution The apparent volume of distribution of solriamfetol is approximately 199 L.

Plasma protein binding ranged from 13.3% to 19.4% over solriamfetol concentration range of 0.059 to 10.1 mcg/mL in human plasma. The mean blood‑to‑plasma concentration ratio ranged from 1.16 to 1.29. Elimination Solriamfetol exhibits first‑order elimination after oral administration.

The apparent mean elimination half‑life is about 7.1 hours. Metabolism Solriamfetol is minimally metabolized in humans. Excretion Approximately 95% of the dose was recovered in urine as unchanged solriamfetol, and 1% or less of the dose was recovered as the minor inactive metabolite N‑acetyl solriamfetol in a mass balance study.

Renal clearance (18.2 L/h) represented the majority of apparent total clearance (19.5 L/h). Active tubular secretion is likely involved in the renal elimination of the parent drug. Specific Populations Population PK analysis indicated that age, gender, and race do not have clinically relevant effects on the pharmacokinetics of solriamfetol.

No dose adjustments were made in clinical studies that enrolled patients ages 65 and above. Patients with Renal Impairment Exposures to solriamfetol in patients with renal impairment compared to subjects with normal renal function (eGFR ≥ 90 mL/min/1.73 m 2 ) are summarized in Figure 1. The half‑life of solriamfetol was increased approximately 1.2‑, 1.9‑, and 3.9‑fold in patients with mild (eGFR 60‑89 mL/min/1.73 m 2 ), moderate (eGFR 30–59 mL/min/1.73 m 2 ), or severe (eGFR <30 mL/min/1.73 m 2 ) renal impairment, respectively.

Exposure (…

🧬 Mechanism of Action 45 words ▾

12.1Mechanism of Action The mechanism of action of solriamfetol to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).

📦 How Supplied / Storage and Handling 95 words ▾

16 HOW SUPPLIED / STORAGE AND HANDLING How Supplied SUNOSI is packaged in 30-count white, high density polyethylene (HDPE) bottles. SUNOSI tablets, 75 mg - dark yellow oblong tablet with "75" debossed on one side and a functional score line on the opposite side. NDC 81968-350-01: Bottles of 30 with child-resistant closure SUNOSI tablets, 150 mg - yellow oblong tablet with "150" debossed on one side.

NDC 81968-351-01: Bottles of 30 with child-resistant closure Storage Store SUNOSI at 20 to 25°C (68°to 77°F); excursions permitted between 15°to 30°C (59°to 86°F) (see USP controlled room temperature).

📦 Storage and Handling 88 words ▾

How Supplied SUNOSI is packaged in 30-count white, high density polyethylene (HDPE) bottles. SUNOSI tablets, 75 mg - dark yellow oblong tablet with "75" debossed on one side and a functional score line on the opposite side. NDC 81968-350-01: Bottles of 30 with child-resistant closure SUNOSI tablets, 150 mg - yellow oblong tablet with "150" debossed on one side. NDC 81968-351-01: Bottles of 30 with child-resistant closure

Storage Store SUNOSI at 20 to 25°C (68°to 77°F); excursions permitted between 15°to 30°C (59°to 86°F) (see USP controlled room temperature).

📋 Description 129 words ▾

11 DESCRIPTION SUNOSI contains solriamfetol, a dopamine and norepinephrine reuptake inhibitor (DNRI). Solriamfetol is a phenylalanine derivative with the systematic name ( R )-2-amino-3-phenylpropylcarbamate hydrochloride. The molecular formula is C 10 H 15 N 2 O 2 Cl, and the molecular weight is 230.69.

The chemical structure is: Solriamfetol hydrochloride is a white to off-white solid that is freely soluble in water. SUNOSI tablets are intended for oral administration. Each 75 mg SUNOSI film-coated tablet contains 75 mg solriamfetol (equivalent to 89.3 mg solriamfetol hydrochloride).

Each 150 mg SUNOSI film-coated tablet contains 150 mg solriamfetol (equivalent to 178.5 mg solriamfetol hydrochloride). The inactive ingredients are hydroxypropyl cellulose and magnesium stearate. In addition, the film coating contains: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Potential for Abuse and Dependence Advise patients that SUNOSI is a federally controlled substance because it has the potential to be abused [see Drug Abuse and Dependence ( 9 )] . Advise patients to keep their medication in a secure place and to dispose of unused SUNOSI as recommended in the Medication Guide.

Primary OSA Therapy Use Inform patients that SUNOSI is not indicated to treat the airway obstruction in OSA and they should use a primary OSA therapy, such as CPAP, as prescribed to treat the underlying obstruction [see Indications and Usage ( 1 )] . SUNOSI is not a substitute for primary OSA therapy. Blood Pressure and Heart Rate Increases Instruct patients that SUNOSI can cause elevations of their blood pressure and pulse rate and that they should be monitored for such effects [see Warnings and Precautions ( 5.1 )] .

Psychiatric Symptoms Instruct patients to contact their healthcare provider if they experience, anxiety, insomnia, irritability, agitation, or signs of psychosis or bipolar disorders [see Warnings and Precautions ( 5.2 )] . Lactation Advise breastfeeding patients using SUNOSI to monitor infants for signs of agitation, insomnia, and reduced weight [see Use in Specific Populations ( 8.2 )] . For more information, visit www.SUNOSI.com Distributed by: Axsome Therapeutics, Inc.

New York, NY 10007 For patent information: www.axsome.com/IP © 2023 Axsome Therapeutics, Inc. SUN-USPI-004.000-20230630

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. SUN-USMG-003.000-20230630 Revised: 06/2023 MEDICATION GUIDE SUNOSI ® (suh-NOH-see) (solriamfetol) tablets, for oral use, CIV What is SUNOSI?

SUNOSI is a prescription medicine used to improve wakefulness in adults with excessive daytime sleepiness that is associated with narcolepsy or obstructive sleep apnea (OSA). It is not known if SUNOSI is safe and effective in children. SUNOSI is not for use to treat the underlying cause of airway obstruction in people with OSA.

SUNOSI does not take the place of using your continuous positive airway pressure (CPAP) machine or other devices that your healthcare provider has prescribed for the treatment of OSA. It is important that you continue to use these treatments as prescribed by your healthcare provider. SUNOSI is a federally controlled substance (CIV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs.

Keep SUNOSI in a safe place to protect it from theft. Never give your SUNOSI to anyone else, because it may cause death or harm them. Selling or giving away SUNOSI may harm others and is against the law.

Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. Do not take SUNOSI if you are taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). Before taking SUNOSI, tell your healthcare provider about all your medical conditions, including if you: have heart problems or have had a heart attack have had a stroke have high blood pressure have kidney problems or diabetes have high cholesterol in your blood have a history of mental health problems, including psychosis and bipolar disorders have a history of drug or alcohol abuse or addiction are pregnant or planning to become pregnant.

It is not known if SUNOSI will harm your unborn baby. Pregnancy Registry: There is a pregnancy registry for women who take SUNOSI during pregnancy. The purpose of this registry is to collect information about the health of you and your baby.

Talk to your healthcare provider about how you can take part in this registry. For more information or to participate in the registry, call 1-877-283-6220 or go to www.SunosiPregnancyRegistry.com are breastfeeding or plan to breastfeed. SUNOSI passes into your breastmilk.

Talk to your healthcare provider about the best way to feed your baby if you take SUNOSI. Tell your healthcare provider about all the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. SUNOSI and some other medicines may affect each other causing possible serious side effects.

SUNOSI may affect the way other medicines work and other medicines may affect the way SUNOSI works. Especially tell your healthcare provider if you take a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). Know the medicines you take.

Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. How should I take SUNOSI? Take SUNOSI exactly as your healthcare provider tells you to.

Do not change your dose of SUNOSI without talking to your healthcare provider. Your healthcare provider may need to change the dose of SUNOSI until it is the right dose for you. Take SUNOSI by mouth 1 time each day when you first wake up.

Avoid taking SUNOSI within 9 hours of your planned bedtime. If you take SUNOSI too close to your bedtime, you may find it harder to go to sleep. SUNOSI can be taken with or without food.

Depending on your prescribed dose, your healthcare provider may tell you to swallow your SUNOSI tablet whole or split the SUNOSI tablet in half at the score line in the middle of the tablet. Ask your healthcare provider if you have questions about how to split the SUNOSI tablet in half the right way. If you take too much SUNOSI, call…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.