Modafinil

Controlled under the Controlled Substances Act.⁶¹² Illegal to sell without DEA license and illegal to buy or possess without a valid prescription. Approved by the FDA in 1998 for narcolepsy, obstructive sleep apnea, and shift work sleep disorder.

China's 2026 Doping Catalogue lists modafinil as a non-specified stimulant. Stimulants, including modafinil, are prohibited in competition under China's anti-doping system; the Catalogue took effect on 1 January 2026.

Modiodal Tablets 100 mg, containing modafinil, are classified by Japan's Pharmaceuticals and Medical Devices Agency as a first-class psychotropic medicine and a prescription medicine. The official package insert states that the product is to be used on the prescription of a physician or other qualified prescriber.

Modafinil is listed in Table II to Law No. 339/2005, Romania's national list of psychotropic substances under control. Activities involving listed psychotropic substances are subject to the law's authorization regime.

Modafinil is listed in List II of the Russian Federation’s list of narcotic drugs and psychotropic substances whose circulation is restricted. Its circulation is subject to the controls that apply to List II substances.

In the Russian instrument, modafinil is specifically a List II psychotropic substance, whose turnover is limited rather than absolutely prohibited. Roszdravnadzor's current Resolution No. 681 consolidation is marked '(ред. от 11.06.2025)' and was posted on 30 March 2026; its attached PDF contains the List II heading and exact modafinil entry. Roszdravnadzor's import guidance says import/export of controlled narcotic and psychotropic medicines is subject to the EAEU licensing framework. Appendix No. 10 paragraph 3 makes a licence the general rule, while paragraph 6(a) provides the narrow personal-medicine exception. The EMERCOM-hosted Criminal Code of the Russian Federation is marked edition 1 July 2021: its Article 228 text provides, for significant-size no-sale conduct, alternatives including a fine up to RUB 40,000, compulsory work up to 480 hours, corrective work up to 2 years, restriction of liberty up to 3 years or imprisonment up to 3 years; large-size conduct carries 3–10 years and especially large-size conduct 10–15 years, with possible additional fine/restriction, while Article 228.1 covers sale. The Code is a 2021 consolidation; for 2026, the current controlled-substance list is the regulator's posting dated 30 March 2026. Exact penalty application remains dependent on the Code edition in force on the conduct date, quantity, intent and facts. The personal-medicine licence exception does not permit an individual to freely possess or import modafinil.

Modafinil is not registered in Singapore. Section 15 of the Health Products Act prohibits supplying an unregistered health product, while HSA says supply or sale of modafinil is an offence unless HSA authorises a doctor’s special-circumstances use for patients under that doctor’s care; the available HSA material does not state a general possession offence.

Classified as a Schedule 4 drug. Prescribed for narcolepsy and hypersomnia. Sold under the brand name Modiodal in 100mg tablets.

The current Poisons Standard lists MODAFINIL in Schedule 4, which is titled ‘Prescription only medicines and prescription animal remedies.’ The instrument commenced on 1 June 2026 and states that Schedule 4 substances should be available from a pharmacist on prescription; it directs readers to relevant State or Territory authorities for legal definitions.

RPV's current NR legend says repeat dispensing is prohibited; RezeptPG § 4(2) provides the controlling exception that a prescriber may expressly order repeat dispensing. The BASG Fachinformation for Modasomil 100 mg (authorization 1-22670; information stand 08.2025) states 'Rezept- und apothekenpflichtig, wiederholte Abgabe verboten' and identifies each tablet as containing 100 mg modafinil; it indicates treatment of adults with excessive sleepiness associated with narcolepsy and initiation by a physician or under specialist physician supervision. The current RIS RPV consolidation is dated 28.08.2026 and records amendments through BGBl. II Nr. 282/2025; the current SV consolidation is dated 28.08.2026 and records amendments through BGBl. II Nr. 180/2026; the current PV consolidation is dated 28.08.2026 and records amendments through BGBl. II Nr. 10/2025. RezeptPG § 6(1) provides up to EUR 3,600 administrative fine for specified unlawful pharmacy dispensing, offering/dispensing outside pharmacies, or forged-prescription conduct (unless a court offence applies); § 6(2) provides forfeiture for medicines/proceeds unlawfully offered or dispensed, and § 6(3) says a purchaser of a prescription medicine outside a pharmacy is not punishable as instigator or aider of § 6(1) Z 2 but the medicine may independently be forfeited. These are ordinary prescription-law consequences, not SMG narcotics penalties; modafinil was absent from the current narcotics and psychotropics schedules.

Provigil, containing modafinil, is a medicine subject to medical prescription in Belgium. It is authorised and marketed in Belgium for the treatment of excessive sleepiness due to narcolepsy in adults.

ANVISA's current consolidated text of Portaria SVS/MS nº 344/1998 lists modafinila at item 65 of Lista B1, the list of psychotropic substances subject to Notificação de Receita B. The consolidated instrument requires that notification for dispensing medicines containing Lista B1 substances and gives it a 30-day nationwide validity, so modafinil is prescription-only under Brazil's special-control regime.

Health Canada's Drug Product Database identifies Canadian products containing modafinil as prescription products. Under the Food and Drug Regulations, a prescription drug may be sold only by a person entitled under provincial law to dispense it and pursuant to a verbal or written prescription, except as provided by section C.01.043.

Modafinilo is authorised in Chile as MODAVITAE and MOVIGIL, registered pharmaceutical products whose ISP records state the sale condition "Receta Retenida". Supply is therefore restricted to the retained-prescription medicines regime recorded for those products.

The State Institute for Drug Control's Database of Medicinal Products identifies ASPENDOS and VIGIL as registered products containing modafinil and classifies their dispensing regime as R (on medical prescription). Modafinil products are therefore supplied on medical prescription in the Czech Republic.

Danish Medicines Agency medicine-price records list modafinil products in delivery group B. Under the Prescription Order, group B medicines are dispensed only on prescription, with repeat dispensing governed by the prescriber's directions.

Available by prescription since 1994 under the brand name Modiodal. Subject to EMA recommendations limiting use to excessive sleepiness associated with narcolepsy.²⁹

Classified as a prescription medicine under Anlage 1 of the Arzneimittelverschreibungsverordnung.³¹ In February 2008, it was removed from Anlage III of the Betäubungsmittelgesetz (similar to US Schedule III-IV) and is now available with a standard prescription.³²

Provigil 100 mg tablets, containing modafinil, are authorised and marketed in Ireland as a prescription-only medicinal product. Supply is therefore through the prescription-medicine system.

Available by prescription under the brand name Provigil.

Modafinil Mylan 100 mg is recorded in the Netherlands Medicines Information Bank with the UR supply classification. UR medicines are supplied only on prescription.

Classified as a prescription medicine under the Medicines Act 1981. Sold under the brand name Modavigil. The Act prohibits importing, procuring, receiving, storing, using, or possessing any prescription medicine without reasonable excuse.

Modiodal, containing modafinil, is listed in the Norwegian Medicines Agency medicines database as prescription-only and in prescription group B. Dispensing is subject to the prescription controls applicable to that group.

The Ministry of Food and Drug Safety records Modanil Tablet 200 mg, containing modafinil, as an active prescription medicine in South Korea. Its supply is subject to the prescription-medicine classification.

AEMPS's current CIMA records identify multiple modafinil products, including Modafinilo Aristo 100 mg comprimidos EFG, as medicines subject to medical prescription. The records identify modafinilo as the active substance and mark the products as requiring a prescription; this prescription requirement applies to authorised modafinil medicines.

Modasomil, which contains modafinil, is dispensed in Swiss pharmacies only on a physician's prescription valid for a single supply. The Swissmedic-approved patient information identifies modafinil as its active ingredient and limits its use to treatment prescribed by a physician.

Turkey's official provincial-health-authority copy of the TİTCK list places MODIODAL 100 mg, MODIOGEN 200 mg and MODIWAKE 100/200 mg products under 'Normal Reçete İle Verilmesi Gereken İzlemeye Tabi İlaç Listesi' (normal prescription, monitoring required). Thus pharmacy supply is not over-the-counter. This is prescription-only/monitored medicine status, not a Schedule I/II label. Modafinil has no specific entry in the 2313 schedules, and no Schedule designation is stated. The Turkish KÜB limits therapeutic use to physician-supervised adult patients with narcolepsy or shift-work sleep disorder with excessive sleepiness, and adults with persistent excessive sleepiness despite primary treatment for obstructive sleep apnoea. TCK arts. 188 and 191 set general penalties for conduct involving a legally applicable 'uyuşturucu veya uyarıcı madde' and do not convert the prescription classification into an automatic controlled-substance schedule. TCK art. 188(6) expressly addresses substances whose production requires official permission or whose sale requires an authorised doctor's prescription when they produce narcotic or stimulant effects.

Modafinil is a prescription-only medicine in the United Kingdom and is licensed only for the treatment of narcolepsy. Under the Human Medicines Regulations 2012, a prescription-only medicine may be sold or supplied only in accordance with a prescription from an appropriate practitioner.

Modafinil has a dispensing condition in the current ANMAT product database; the database does not establish a broader criminal or scheduling status.

Not classified as a controlled substance but regulated as a prescription drug. As of February 2011, pharmacies do not typically stock modafinil and the European Medicines Agency recommends restricting its use to narcolepsy treatment only.²⁹

Modafinil is not included among the psychotropic substance groups in Article 245 of Mexico's General Health Law. It is therefore not scheduled as a psychotropic substance under that provision.