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Prescription medicine

Solriamfetol Brand names: Sunosi

Solriamfetol (Sunosi) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $31.34 per Sunosi 150 mg tablet in the October 7, 2026 NADAC survey.

  • No generic listed
  • DEA Schedule IV

Check it at the source: the solriamfetol FDA label on DailyMed (effective May 5, 2026, Axsome Therapeutics, Inc.); the NDA 211230 record on Drugs@FDA; every solriamfetol label on DailyMed.

Highlights of the record

FDA label of May 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: 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 )].

Forms and strengths

  • 75 mg
  • 150 mg

Film-coated tablet.

On the market

Earliest approval on file
March 20, 2019 Sunosi, Axsome Malta; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals
2 first June 17, 2026; 2 with a marketed status in Drugs@FDA
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent
December 30, 2042 Sunosi tablets; not a generic launch date

Supply and safety

Pharmacy cost (NADAC)
$31.34 per tablet Sunosi 150 mg tablet
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
3,777 through July 30, 2026

What is solriamfetol used for?

From the label: 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. […]

FDA pharmacologic class: Dopamine and Norepinephrine Reuptake Inhibitor.

Source: FDA drug label (SUNOSI), Axsome Therapeutics, Inc., effective May 5, 2026 (SPL set 362f206b-73e7-4009-8c34-5a9df55679ab), via openFDA; the full label on DailyMed

Is there a generic for solriamfetol (Sunosi)?

The FDA approved the first generic solriamfetol on June 17, 2026. 2 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.

The Orange Book lists 42 patents for Sunosi tablets: the compound patent runs to November 1, 2038, and the last listed entry to December 30, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

  • 2019 earliest approval on file
  • 2026 first generic approved
  • 2042 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for solriamfetol (Sunosi)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $31.34 per Sunosi 150 mg tablet, up 6% from $29.49 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

  • Sunosi 150 mg tablet (brand)
$31.34
$27.85
January 2024October 2026
NADAC per unit, October 7, 2026
Strength and formBrand or genericPharmacy cost30 tablets, or one pen or vial12-month change
Sunosi 150 mg tabletBrand$31.34 per tablet$940.29+6%
Sunosi 75 mg tabletBrand$31.37 per tablet$941.07+6%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

What do FAERS reports show for solriamfetol?

The FDA Adverse Event Reporting System holds 3,777 reports that list solriamfetol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14 are coded as a death and 329 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)539
  • Anxiety (named in the label)335
  • Headache (named in the label)313
  • Nausea (named in the label)296
  • Fatigue266
  • Product Administration Interrupted266
  • Off Label Use (a use or a product term, not a reaction)251
  • Somnolence243

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Solriamfetol side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other