Armodafinil

Controlled under the Controlled Substances Act as a Schedule IV substance, indicating accepted medical use with low potential for abuse relative to Schedule III drugs.⁵⁸⁵⁹ Purchasing, selling, or possessing armodafinil without a valid prescription or DEA license is illegal.⁵⁹

Armodafinil is not separately named in Swedish instruments. Under the express stereoisomer rule rather than an inference from modafinil control, LVFS 2011:10 states that narcotics include stereoisomers of substances in P I–P IV unless otherwise stated. The current government text lists modafinil in Annex 1 as a substance deemed narcotics under the Narcotic Drugs Penal Law. Sweden’s Schedule IV placement of modafinil supplies the expressly covered stereoisomer category.

Classified as a prescription-only medicine or prescription animal remedy under the Poisons Standard.⁹ Defined as a substance whose use or supply should be by or on the order of persons permitted by State or Territory legislation to prescribe, available only from a pharmacist on prescription.⁹

Armodafinila is directly and nominally listed in Lista B1, not merely reached through the B1 adendo for salts, ethers, esters, and isomers. The controlling effect is regulated prescription dispensing through Notificação de Receita B (blue), rather than prohibition. For international arrival/departure by a natural person, art. 32(2) forbids transport of a medicine containing a listed substance without a copy of the medical prescription. Commercial production, distribution, transport, import, export, and related listed-substance activities require Autorização Especial under art. 2; this is not a general personal-use ban.

Listed in Anlage 1 of the Arzneimittelverschreibungsverordnung (AMVV), the German Prescription Ordinance. Legal possession and dispensing requires a valid prescription from an authorized prescriber.³³

Not directly scheduled as of 2021, but considered related to modafinil which is classified as a doping agent and will appear on laboratory tests.³⁴ Simple possession is not a criminal offense but carries administrative penalties including fines and confiscation. Importing or exporting without a valid medical prescription constitutes a criminal offense punishable by two to seven years imprisonment.³⁴

Schedule F is not the current Canadian prescription-status instrument: Health Canada's guidance says the 2013 amendment repealed Schedule F and replaced it with the Prescription Drug List (PDL). The PDL's exact entry is Modafinil or its salts, while armodafinil is a distinct R-enantiomer and is not separately named. The current PDL human and veterinary pages give prescription status to listed modafinil products; they do not establish that armodafinil is routinely authorized or lawfully prescribed in Canada. Health Canada's Teva-modafinil product monograph expressly identifies armodafinil as the R-enantiomer of modafinil and says it is not marketed in Canada. The Health Canada DPD is the database for drugs authorized for sale and its official extract page says extracts include marketed, approved, cancelled and dormant products; the marketed, approved, cancelled and dormant drug extracts updated 2026-08-04 contained no armodafinil record, while marketed records contained modafinil products. Health Canada's Special Access Programs provide a possible practitioner-led route for non-marketed human or veterinary drugs, but SAP access is not ordinary marketing or a general prescription entitlement and requires the applicable request process. The CDSA consolidation is current to 2026-06-21 and was last amended 2026-06-05; it contains no armodafinil or modafinil name in Schedules I-VI. Section 4's possession offence applies only to substances in Schedules I-III, sections 5 and 7 address substances in Schedules I-V, and section 6 addresses substances in Schedules I-VI; accordingly, the CDSA establishes no schedule-specific possession, trafficking, production or import/export penalty for armodafinil under these provisions. If a future Health Canada status determination treated a particular form as controlled, the applicable schedule would control the CDSA maxima. Separately, Food and Drugs Act section 31.2 provides therapeutic-product contravention maxima of indictment fine up to $5,000,000 or two years' imprisonment (or both), and summary first-offence fine up to $250,000 or six months, subsequent fine up to $500,000 or 18 months (or both); that is a conduct-specific provision, not a declaration that mere possession of armodafinil has those penalties. Food and Drug Regulations C.01.041 restricts sale of a prescription drug through the listed prescription/dispenser routes, but armodafinil's own PDL listing and Canadian authorization status are not established, so no routine Canadian prescription route follows. Provincial pharmacy rules, customs treatment and a product-specific SAP decision are not addressed by these federal provisions.

Armodafinil is not listed as a controlled drug in the current schedules to the Misuse of Drugs Act 1971 or Misuse of Drugs Regulations 2001. The MHRA nevertheless expressly identifies armodafinil as an unlicensed medicine used for narcolepsy. HMR regulation 46 prohibits unauthorised sale/supply and certain possession for onward supply; regulation 47 provides a summary statutory-maximum fine or, on indictment, a fine and up to two years' imprisonment or both. Regulation 167 is a tightly conditioned special-patient-needs exception, not a general personal-import permission. The Psychoactive Substances Act Schedule 1 expressly exempts medicinal products. Section 13 of the Medicines Act 1968 is repealed and does not support a current personal-use import claim. No standalone current UK marketing authorisation or individual armodafinil POM classification is established, and the MHRA notice's general POM wording does not establish a product-wide classification.