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solriamfetol

Sunosi · ATC code N06BA14

Key facts
Active substance
solriamfetol
ATC code
N06BA14
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Sunosi 75 mg film-coated tablets / Sunosi 150 mg film-coated tablets
Marketing authorisation holder
Atnahs Pharma Netherlands B.V.
Information as of
2026-10-27

Key facts

Solriamfetol is a wake-promoting agent used in adults with narcolepsy or obstructive sleep apnoea to improve wakefulness and reduce excessive daytime sleepiness.

What it is used for

  • Excessive daytime sleepiness in narcolepsy (with or without cataplexy) in adults
  • Excessive daytime sleepiness in obstructive sleep apnoea not satisfactorily treated by primary therapy such as CPAP
  • Not a therapy for the underlying airway obstruction

Dosing

  • Narcolepsy: start 75 mg once daily on awakening (150 mg may be considered for more severe sleepiness); maximum 150 mg daily.
  • OSA: start 37.5 mg once daily on awakening; double at intervals of at least 3 days, maximum 150 mg daily.
  • Avoid taking less than 9 hours before bedtime.
  • Moderate renal impairment: start 37.5 mg, maximum 75 mg after 5 days; severe: 37.5 mg once daily.
  • Elderly: consider lower doses and close monitoring.

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Myocardial infarction within the past year, unstable angina, uncontrolled hypertension, serious arrhythmias or other serious heart problems
  • MAOIs concomitantly or within 14 days after stopping them

Important warnings

  • Dose-dependent increases in blood pressure and heart rate; assess before and monitor periodically
  • Caution in patients at higher risk of major adverse cardiac events
  • Psychiatric symptoms such as anxiety, insomnia and irritability; caution with psychosis or bipolar disorder

Side effects

  • Most frequent: headache (11.1%), nausea (6.6%), decreased appetite (6.8%)
  • Common: anxiety, insomnia, irritability, dizziness, palpitations, blood pressure increased
  • Common: diarrhoea, dry mouth, abdominal pain, hyperhidrosis, chest discomfort

Interactions

  • MAOIs: contraindicated (risk of hypertensive reaction)
  • Medicines that raise blood pressure and heart rate: caution
  • Dopaminergic medicines: possible pharmacodynamic interactions

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception.
  • Excreted in human milk; a decision is needed between breast-feeding and therapy.

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

Package leaflet for patients →

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • SunosiAtnahs Pharma Netherlands B.V. · EMEA/H/C/004893

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Sunosi
Liechtenstein
Sunosi
Norway
Sunosi

EMA – Article 57 product data (EU/EEA), 2026-10-28

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

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Sources

  1. European Medicines Agency. Sunosi – EPAR, Product Information (OF THE TEXT MM/YYYY Detailed information on this medicinal p). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/sunosi-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.