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Nootropics · Reference article

Modafinil legal status by country: US, UK, EU, Canada, Australia

Prescription and controlled-substance status of modafinil and armodafinil in 10 countries, read from official sources, with possession, supply and import.

Published · Updated · Rests on: US CFR, Federal Register rule and FDA labels; UK, German, Dutch, Canadian and Polish legislation or registers; French, Spanish and Australian regulator databases; INCB Green List; 3 countries not verified

This is a reference article, not a price comparison. Peptilyze compares prices of research peptides; it sells nothing and gives no medical advice. Every claim is numbered and listed under Sources.

Key points

  • Where we could open an official source, modafinil is prescription-only. Only the United States lists it as a controlled substance (Schedule IV) [3][4]. Australia puts it in Schedule 4, the prescription-only tier [29].
  • The UK, Germany, the Netherlands, Canada and Poland do not list it in their controlled-substance schedules as we read them [8][9][15][21][24][26].
  • Possession and supply differ: the sources we opened mostly regulate sale, supply and import, not possession of a non-controlled prescription medicine.
  • Italy, several controlled-substance lists and some import rules could not be verified and are marked “not verified”.
  • We found no WHO or CND decision on modafinil, and it is absent from the INCB list of internationally controlled psychotropics [31].

This article is information, not legal advice. Laws change and apply to individual facts. All sources were read on 8 November 2026 unless another date is given. For what modafinil is and what trials show, see the modafinil complete guide.

How we checked

We used scheduling lists, legislation, regulator databases and agency guidance only. Where an official site blocked or timed out our requests (Légifrance, Italy’s health ministry, the Australian TGA), we did not work around it and mark the point “not verified”. A drug can be prescription-only without being controlled.

Summary table

Country Modafinil: prescription Modafinil: controlled-substance status Armodafinil
United States Rx only [1] Schedule IV, 21 CFR 1308.14(f)(7) [3][4] Rx only, Schedule IV per label [2]
United Kingdom Prescription-only medicine [13] Not in MDA 1971 Sch. 2 or MDR 2001 Sch. 1-5 [8][9] Not in those schedules; prescription status not checked
Germany Prescription-only (AMVV Anlage 1) [14] Not in BtMG Anlagen I-III [15] Named in none of these lists
France Liste I, restricted initial prescription [18][19] Narcotics list not verified Not checked
Netherlands “Uitsluitend recept” [20] Not on Opiumwet lists I or II [21] Not on those lists
Spain Prescription-only (CIMA) [22] Not verified Not checked
Italy Not verified Not verified Not verified
Poland Authorised (Actimodan) [23]; dispensing category not verified Not in the Ministry of Health list [24] Not checked
Canada Prescription [25] Not in the Controlled Drugs and Substances Act [26] No product in Health Canada’s database [25]; not in the Act [26]
Australia Schedule 4 (prescription-only medicine) [29] Not Schedule 8 (controlled drug) [29] Schedule 4 [29]

United States

Modafinil is a prescription drug and a Schedule IV controlled substance. The Provigil label calls it “a Schedule IV controlled substance” and carries “Rx only” [1]. The regulation lists “Modafinil” in 21 CFR 1308.14(f), item (7), DEA code 1680 (eCFR version of 1 November 2026) [3]. The DEA’s final rule, effective 27 January 1999, placed modafinil “including its salts, isomers and salts of isomers” in Schedule IV [4]. The regulation does not name armodafinil; the Nuvigil label (published 15 September 2026) states it is a Schedule IV controlled substance [2].

Possession. Federal law makes it unlawful to knowingly possess a controlled substance unless it was obtained directly or under a valid prescription from a practitioner (21 U.S.C. 844(a)); the statute sets up to one year in prison and a minimum $1,000 fine for a violation without prior convictions [5]. Supply falls under other provisions of the Controlled Substances Act that we did not open.

Import. The statute makes it unlawful to import a non-narcotic Schedule IV substance unless it is imported for medical, scientific or other legitimate uses and under the notification or declaration the Attorney General prescribes (21 U.S.C. 952(b)) [6]. The FDA states that “in most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use” and that the DEA generally decides on controlled substances (page current as of 18 August 2025) [7].

United Kingdom

Modafinil is a prescription-only medicine (SmPC revised 14 February 2024) [13]. Neither modafinil nor armodafinil appears in Schedule 2 of the Misuse of Drugs Act 1971 or Schedules 1 to 5 of the Misuse of Drugs Regulations 2001 as published on legislation.gov.uk [8][9]. It is not a controlled drug.

Possession versus supply. Regulation 214 of the Human Medicines Regulations 2012 says a person may not sell or supply a prescription-only medicine except in accordance with a prescription [10]. The MHRA states: “It’s a criminal offence to supply prescription only medicines without a valid prescription” [11]. Both concern supply; we opened no provision on possession.

Import. The government page on controlled-drug personal licences covers only controlled medicines and refers others to the MHRA (updated 11 April 2023) [12]. We found no MHRA page on personal import of non-controlled prescription medicines: not verified.

Germany

Modafinil is on the prescription-only list, AMVV Anlage 1 [14]. It is in none of Anlagen I, II or III of the Betäubungsmittelgesetz [15]. Armodafinil is named in none of these lists.

Possession versus supply. Section 95(1) no. 4 of the Arzneimittelgesetz punishes trading in or supplying prescription-only medicines contrary to section 43 with up to three years in prison or a fine [17]. That concerns supply; we opened no provision on possession.

Import. Section 73(1) of the AMG bars bringing in medicines that need authorisation unless they are authorised in Germany and other conditions are met. Section 73(2) exempts amounts matching usual personal need brought in on entry (no. 6) and personal-need amounts obtained from an EU or EEA state where the product may be marketed, without commercial or professional intermediation (no. 6a). Section 73(1b) prohibits bringing in falsified medicines [16]. We did not assess how these interact with the prescription requirement.

Other EU states

France. The public medicines database (updated 3 November 2026) lists Modiodal and a generic as “liste I”, with initial prescription each year reserved for neurology specialists and sleep centres [18][19]. The entries show no narcotics classification, but Légifrance refused our request, so controlled-substance status and import: not verified.

Netherlands. The Dutch medicines database lists Modiodal as “Uitsluitend recept” (prescription only) [20]. The Opiumwet (version valid from 17 September 2026) names neither modafinil nor armodafinil in lists I or II [21]. Possession and import rules: not verified.

Spain. The AEMPS database (CIMA) lists six marketed modafinil products, each flagged as subject to medical prescription [22]. Controlled status, possession and import: not verified.

Italy. We obtained no readable official record (the health ministry site refused our request). Prescription status, controlled status and import: not verified.

Poland. The national register lists two Actimodan tablet products (100 mg, 200 mg) [23]; the detail record with the dispensing category was access-denied, so prescription category: not verified. The consolidated Ministry of Health regulation listing psychotropic substances, narcotics and new psychoactive substances (Dz.U. 2026 poz. 1419) does not name modafinil [24]. Import: not verified.

Canada

Health Canada’s drug database lists Alertec (modafinil 100 mg) with schedule “PRESCRIPTION” and status “Marketed” (record updated 4 August 2026) [25]. The Controlled Drugs and Substances Act, current to 19 October 2026, names neither modafinil nor armodafinil [26]. A search of the database for armodafinil returned no product [25].

Import. Health Canada guidance GUI-0116 (page modified 13 July 2026) says residents are generally not allowed to bring prescription drugs into Canada, carried or delivered by mail or courier. It allows exceptions, for example residents returning with drugs prescribed and filled in Canada, up to a 90-day supply [27]. Another Health Canada page repeats that residents “are generally not allowed to import prescription drugs ordered online or purchased abroad” [28]. Possession of an unscheduled prescription drug and sale under the Food and Drugs Act: not verified.

Australia

The Poisons Standard (October 2026 instrument, registered 30 September 2026) lists both MODAFINIL and ARMODAFINIL in Schedule 4 [29]. The standard’s label signal words are “PRESCRIPTION ONLY MEDICINE” for Schedule 4 (human use) and “CONTROLLED DRUG” for Schedule 8 [29]. The June 2026 instrument was repealed on 1 October 2026 [30]. Possession, supply and import rules (TGA, state poisons laws): not verified.

Why status differs

US scheduling followed a formal process. The Department of Health and Human Services recommended Schedule IV on 22 December 1997, and the DEA found “a low potential for abuse relative to the drugs or other substances in Schedule III” and potential for “limited physical dependence and psychological dependence” [4].

Internationally, the INCB Green List (35th edition, 2024) of psychotropics controlled under the 1971 Convention contains neither modafinil nor armodafinil, though it lists zolpidem and methylphenidate [31]. The WHO Expert Committee on Drug Dependence advises on such listings. We found no ECDD review or CND decision on modafinil; the 36-page copy of the 34th ECDD report we could open does not mention it [32]. That is not a search of every ECDD report. Our reading: without an international listing each country decides for itself, which fits a US schedule alongside prescription-only status elsewhere.

Counterfeit risk, as regulators document it

Health Canada (page dated 23 October 2026) lists risks of drugs from illegitimate online sellers: expired drugs, “the wrong ingredients”, “counterfeit drugs with no active ingredients” and drugs contaminated with other drugs [28]. In 2016 the MHRA said nearly 5,000 websites selling fake or unlicensed medicines had been shut down that year and that Operation Pangea seized more than 31,000 doses of narcolepsy medication; the release does not say how much was modafinil [11]. More in counterfeit modafinil risks and customs.

Risks and unknowns

Legal status is a snapshot; customs practice, state or provincial law and prescriber rules sit outside the documents we opened. Medical risks (serious skin reactions, hormonal contraception) are in the modafinil complete guide.

Frequently asked questions

Is modafinil a controlled substance?

In the United States, yes: Schedule IV under 21 CFR 1308.14 [3]. In the UK, Germany, the Netherlands and Canada it is not in the schedules we searched [8][9][15][21][26]. Australia lists it in Schedule 4, not the controlled-drug Schedule 8 [29]. It is not on the INCB list of internationally controlled psychotropics [31].

It depends on the country and on a prescription. In the US, possessing a controlled substance without a valid prescription is unlawful [5]. For the UK and Germany, the provisions we opened regulate supply, not possession [10][11][17].

Is armodafinil treated like modafinil?

In the US both are Schedule IV [2][4], and in Australia both are Schedule 4 [29]. Neither is in the UK, German, Dutch or Canadian controlled-drug lists [8][9][15][21][26]. Other countries: not checked.

Sources

  1. Apotex Corp., “PROVIGIL (modafinil) tablets, prescribing information”, DailyMed (revised February 2025; read 2026-11-08). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0391f182-1958-9fef-a944-53b229ce99e7
  2. Apotex Corp., “NUVIGIL (armodafinil) tablets, prescribing information”, DailyMed (published 15 Sep 2026; read 2026-11-08). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a69631d0-1263-769e-b232-4ab9160e0fa3
  3. US Government, “21 CFR 1308.14 Schedule IV”, eCFR versioner, version of 2026-11-01 (read 2026-11-08). https://www.ecfr.gov/api/versioner/v1/full/2026-11-01/title-21.xml?part=1308&section=1308.14
  4. Drug Enforcement Administration, “Schedules of Controlled Substances: Placement of Modafinil Into Schedule IV”, 64 FR 4050 (27 Jan 1999). https://www.govinfo.gov/content/pkg/FR-1999-01-27/html/99-1791.htm
  5. US Code, “21 U.S.C. 844 Penalties for simple possession”, Cornell LII (read 2026-11-08). https://www.law.cornell.edu/uscode/text/21/844
  6. US Code, “21 U.S.C. 952 Importation of controlled substances”, Cornell LII (read 2026-11-08). https://www.law.cornell.edu/uscode/text/21/952
  7. FDA, “Personal Importation” (content current as of 08/18/2025; read 2026-11-08). https://www.fda.gov/industry/import-basics/personal-importation
  8. legislation.gov.uk, “Misuse of Drugs Act 1971, Schedule 2” (up to date, read 2026-11-08). https://www.legislation.gov.uk/ukpga/1971/38/schedule/2
  9. legislation.gov.uk, “Misuse of Drugs Regulations 2001, Schedules 1-5” (read 2026-11-08). https://www.legislation.gov.uk/uksi/2001/3998/schedule/4
  10. legislation.gov.uk, “Human Medicines Regulations 2012, regulation 214” (up to date to 8 Nov 2026). https://www.legislation.gov.uk/uksi/2012/1916/regulation/214
  11. MHRA, “Freshers warned to be smart and avoid Modafinil” (26 Sep 2016). https://www.gov.uk/government/news/freshers-warned-to-be-smart-and-avoid-modafinil
  12. GOV.UK, “Travelling with medicine containing controlled drugs” (updated 11 Apr 2023). https://www.gov.uk/guidance/controlled-drugs-personal-licences
  13. Milpharm Ltd, “Modafinil 200 mg tablets, SmPC”, electronic medicines compendium (revised 14 Feb 2024). https://www.medicines.org.uk/emc/product/4320/smpc
  14. Bundesministerium der Justiz, “AMVV Anlage 1” (read 2026-11-08). https://www.gesetze-im-internet.de/amvv/anlage_1.html
  15. Bundesministerium der Justiz, “Betäubungsmittelgesetz, Anlagen I, II and III” (read 2026-11-08). https://www.gesetze-im-internet.de/btmg_1981/anlage_iii.html
  16. Bundesministerium der Justiz, “AMG § 73 Verbringungsverbot” (read 2026-11-08). https://www.gesetze-im-internet.de/amg_1976/__73.html
  17. Bundesministerium der Justiz, “AMG § 95 Strafvorschriften” (read 2026-11-08). https://www.gesetze-im-internet.de/amg_1976/__95.html
  18. ANSM / Ministère de la Santé, “MODIODAL 100 mg, comprimé”, Base de données publique des médicaments (updated 3 Nov 2026). https://base-donnees-publique.medicaments.gouv.fr/medicament/66805883/extrait
  19. ANSM / Ministère de la Santé, “MODAFINIL EG 100 mg, comprimé”, Base de données publique des médicaments (updated 3 Nov 2026). https://base-donnees-publique.medicaments.gouv.fr/medicament/69346054/extrait
  20. CBG-MEB, “Modiodal 100 mg tabletten (RVG 18535)”, Geneesmiddeleninformatiebank (SmPC part change 13 Oct 2026). https://www.geneesmiddeleninformatiebank.nl/nl/rvg18535
  21. Overheid.nl, “Opiumwet (BWBR0001941)”, lijst I and II, valid from 17 Sep 2026 (read 2026-11-08). https://wetten.overheid.nl/BWBR0001941
  22. AEMPS, CIMA REST search, active ingredient “modafinil” (read 2026-11-08). https://cima.aemps.es/cima/rest/medicamentos?practiv1=modafinil&comerc=1
  23. Urząd Rejestracji Produktów Leczniczych, Rejestr Produktów Leczniczych, public search “Modafinilum” (read 2026-11-08). https://rejestrymedyczne.ezdrowie.gov.pl/api/rpl/medicinal-products/search/public?commonName=Modafinilum&page=0&size=10
  24. Minister Zdrowia, “Obwieszczenie z dnia 21 września 2026 r. … jednolitego tekstu rozporządzenia … w sprawie wykazu substancji psychotropowych, środków odurzających oraz nowych substancji psychoaktywnych”, Dz.U. 2026 poz. 1419 (28 Oct 2026). https://api.sejm.gov.pl/eli/acts/DU/2026/1419/text.pdf
  25. Health Canada, Drug Product Database API, drug code 63139 (ALERTEC) and active-ingredient search (read 2026-11-08). https://health-products.canada.ca/api/drug/schedule/?lang=en&id=63139&type=json
  26. Justice Laws Website, “Controlled Drugs and Substances Act” (current to 2026-10-19; read 2026-11-08). https://laws-lois.justice.gc.ca/eng/acts/C-38.8/FullText.html
  27. Health Canada, “Bringing health products into Canada for personal use (GUI-0116)” (page modified 2026-07-13). https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/importation-exportation/personal-use-health-products-guidance/document.html
  28. Health Canada, “Buying drugs online” (page details 2026-10-23). https://www.canada.ca/en/health-canada/services/buying-drugs-over-internet.html
  29. Department of Health, Disability and Ageing, “Therapeutic Goods (Poisons Standard-October 2026) Instrument 2026”, F2026L01327 (registered 30 Sep 2026; read 2026-11-08). https://www.legislation.gov.au/F2026L01327/asmade/2026-09-30/text/original/pdf
  30. Federal Register of Legislation, API record for F2026L00633 (June 2026 instrument, repealed 1 Oct 2026; read 2026-11-08). https://api.prod.legislation.gov.au/v1/titles/F2026L00633
  31. International Narcotics Control Board, “Green List: List of Psychotropic Substances under International Control”, 35th edition (2024). https://www.incb.org/documents/Psychotropics/forms/greenlist/2025/2412193E.pdf
  32. WHO, “Expert Committee on Drug Dependence: thirty-fourth report” (text search for modafinil; copy hosted by drugsandalcohol.ie). https://www.drugsandalcohol.ie/12421/1/WHO_Expert_committee_34th_report.pdf

This article is information, not medical advice.

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