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Armodafinil

Nuvigil · ATC code N06BA13

Key facts
Active substance
Armodafinil
ATC code
N06BA13
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Armodafinil is a wakefulness-promoting agent (the R-enantiomer of modafinil). Per the US prescribing information, it is used to improve wakefulness in adults with excessive sleepiness due to obstructive sleep apnea, narcolepsy or shift work disorder.

What it is used for

  • Excessive sleepiness associated with obstructive sleep apnea (OSA) in adults – it treats the sleepiness, not the underlying obstruction; CPAP should be tried adequately first where it is the treatment of choice
  • Excessive sleepiness associated with narcolepsy in adults
  • Excessive sleepiness associated with shift work disorder (SWD) in adults

Dosing

  • OSA or narcolepsy: 150 mg to 250 mg orally once a day as a single dose in the morning; in OSA, doses above 150 mg/day showed no consistent additional benefit
  • Shift work disorder: 150 mg once a day, approximately 1 hour before the start of the work shift
  • Severe hepatic impairment: the dose should be reduced
  • Elderly patients: lower doses and close monitoring should be considered

Contraindications

  • Known hypersensitivity to modafinil or armodafinil or to any of the inactive ingredients

Important warnings

  • Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, some requiring hospitalisation; not approved for use in pediatric patients
  • DRESS/multiorgan hypersensitivity, angioedema and anaphylaxis reactions
  • Persistent sleepiness: patients should be reassessed; effects on the ability to drive and use machinery
  • Psychiatric symptoms
  • Cardiovascular events

Side effects

  • Most common (≥ 5%, more often than with placebo): headache, nausea, dizziness and insomnia
  • Serious: severe rash, DRESS, angioedema/anaphylaxis, psychiatric symptoms, cardiovascular events

Interactions

  • CYP3A4/5 substrates (e.g. steroidal contraceptives, cyclosporine, midazolam, triazolam): clearance may be increased and exposure lowered; dose adjustment should be considered
  • Steroidal contraceptives may be less effective during treatment and for one month after stopping; alternative or additional contraception is recommended

Pregnancy and breastfeeding

  • Data in pregnant women are insufficient; intrauterine growth restriction and spontaneous abortion have been reported with armodafinil and modafinil
  • Animal studies showed developmental toxicity at clinically relevant exposures

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

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For patients

Patient information (US)

This product has no separate US patient information.

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.

Turkey

  • NuvigilTEVA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • NuvigilCephalon, LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

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

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Sources

  1. U.S. Food and Drug Administration. Armodafinil (Mylan Pharmaceuticals Inc.) – Prescribing Information, 2018-09-17. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=de0799f7-7644-4057-a7da-75436f978c61
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.