Modafinil
Modafinil Aristo, Modasomil · ATC code N06BA07
Also known as: modifil · Brand names: Modafinil Aristo, Modasomil, Modafinil Aurobindo, Modafinil Glenmark, Modafinil Heumann, Modafinil Neuraxpharm, Vigil, Cralium, Modiodal, Modiogen, Modivigil, Modiwake, Sleepex, Provigil
- Key facts
- Active substance
- Modafinil
- ATC code
- N06BA07
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Key facts
Modafinil is a wakefulness-promoting agent. Per the US label it is used in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea or shift work disorder.
What it is used for
- Improving wakefulness in adults with excessive sleepiness associated with narcolepsy
- Obstructive sleep apnea (OSA): treats sleepiness only, not the underlying obstruction; CPAP continues
- Shift work disorder (SWD)
Dosing
- Narcolepsy and OSA: 200 mg once daily in the morning; doses up to 400 mg/day were tolerated without consistent added benefit
- Shift work disorder: 200 mg once daily about 1 hour before the work shift
- Severe hepatic impairment: reduce to one-half of the usual dose
- Elderly: consider lower doses and close monitoring
Contraindications
- Known hypersensitivity to modafinil, armodafinil or any inactive ingredient
Important warnings
- Serious rash including Stevens-Johnson syndrome, TEN and DRESS; not approved for pediatric use
- Angioedema, anaphylaxis and multi-organ hypersensitivity reactions
- Persistent sleepiness may remain; effects on driving ability
- Psychiatric symptoms
- Cardiovascular events (e.g. chest pain, palpitations)
Side effects
- Most common (≥5%): headache, nausea, nervousness, rhinitis, diarrhea, back pain, anxiety, insomnia, dizziness, dyspepsia
- Serious: severe skin reactions, hypersensitivity reactions, psychiatric symptoms
Interactions
- Increased clearance of CYP3A4/5 substrates (e.g. cyclosporine, midazolam, triazolam); consider dose adjustment
- Steroidal contraceptives: reduced effectiveness during use and for one month after stopping; alternative or additional contraception recommended
Pregnancy and breastfeeding
- Intrauterine growth restriction and spontaneous abortion have been reported; use only if the potential benefit justifies the potential risk to the fetus
- Unknown whether excreted in human milk; caution when nursing
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.
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For patients
Patient information (US)
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.
Austria
- Modafinil AristoAristo Pharma Gmbh (Art 57) · 1 register entry
- ModasomilNeuraxpharm Pharmaceuticals S.L. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Modafinil AristoAristo Pharma Gmbh (Art 57) · 1 register entry
- Modafinil AurobindoPuren Pharma Gmbh & Co. Kg · 1 register entry
- Modafinil GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
- Modafinil HeumannHeumann Pharma Gmbh & Co. Generica Kg · 1 register entry
- Modafinil NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry
- VigilNeuraxpharm Pharmaceuticals S.L. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- CraliumSANTA FARMA İLAÇ SAN. A.Ş. · 2 register entries
- ModiodalTEVA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- ModiogenGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 2 register entries
- ModivigilLİBA LABORATUARLARI A.Ş., ADEKA İLAÇ SAN. VE TİC. A.Ş. · 3 register entries
- ModiwakeGENVEON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- SleepexABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- ProvigilApotex Corp, Cephalon, LLC · 3 register entries
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 21 more European countries
- Belgium
- Provigil
- Bulgaria
- Аспендос
- Croatia
- Vigifinil
- Cyprus
- Aspendos, Modiodal
- Czechia
- Aspendos, Vigil
- Denmark
- Modafinil, Modiodal, Myldamo
- Finland
- Modafinil Orion
- France
- Modafinil Arrow, Modafinil Biogaran, Modafinil Eg, Modafinil Viatris, Modafinil Zentiva, Modlodal
- Greece
- Aspendos
- Iceland
- Aspendos, Myldamo
- Ireland
- Modafinil Bluefish, Modafinil Forza, Provigil
- Italy
- Provigil
- Luxembourg
- Provigil
- Netherlands
- Aspendos, Modafinil Aurobindo, Modafinil Emona, Modafinil Focus, Modafinil Mylan, Modiodal
- Norway
- Modiodal
- Poland
- Actimodan
- Portugal
- Modafinil Forza, Modafinil Generis, Modiodal
- Romania
- Aspendos
- Slovakia
- Aspendos
- Spain
- Modafinilo Aristo, Modafinilo Aurovitas, Modafinilo Bluefish, Modafinilo Forza, Modafinilo Tarbis, Modafinilo Viatris, Modiodal
- Sweden
- Modafinil Forza, Modafinil Orifarm, Modafinil Orion, Modafinil Sandoz, Myldamo
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.
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Sources
- U.S. Food and Drug Administration. Modafinil (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.) – Prescribing Information, 2026-09-03. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1a309416-bd6a-45b1-982f-b689b097453d
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
Editorial: Medelix editorial team · last updated 2026-10-27 · 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.