Regulatory status by country
This page is a reference summary of published evidence and regulatory documents. It is not a substitute for individual medical advice, and it is not a recommendation to take or avoid any medicine.
Medically reviewed by Dr. Sofia Lindqvist, · Last reviewed 11 August 2026
Last verified 11 August 2026. Next scheduled verification 11 November 2026.
Educational information, not legal advice. Regulatory status changes, and this table may lag a recent change. Anyone with a legal question about a specific jurisdiction should consult the national medicines regulator or a qualified professional in that country.
On this page
How to read this table
Prescription status records whether the drug can be legally supplied without a prescription.
Controlled scheduling records whether the drug sits under a controlled substances regime in addition to being prescription only. These are separate questions. A drug can be prescription only without being controlled, which is the case for modafinil in several countries.
Personal import records whether the jurisdiction permits importing a personal supply. This entry states the rule and nothing further.
Cells marked Unverified could not be confirmed against the primary regulator at the last check. They are left marked rather than filled with a plausible guess.
15
jurisdictions tracked for modafinil
8
drugs covered
Quarterly
verification cycle
11 Aug 2026
last verified
Modafinil
| Jurisdiction | Prescription required | Controlled scheduling | Personal import | Source |
|---|---|---|---|---|
| United States | Yes | Schedule IV | UNVERIFIED | DEA, FDA |
| United Kingdom | Yes | Not controlled | UNVERIFIED | MHRA |
| Canada | Yes | UNVERIFIED | UNVERIFIED | Health Canada |
| Australia | Yes | Schedule 4 | UNVERIFIED | TGA |
| Germany | Yes | UNVERIFIED | UNVERIFIED | BfArM |
| France | Yes | UNVERIFIED | UNVERIFIED | ANSM |
| Netherlands | Yes | UNVERIFIED | UNVERIFIED | UNVERIFIED |
| Ireland | Yes | UNVERIFIED | UNVERIFIED | HPRA |
| India | Yes | UNVERIFIED | UNVERIFIED | CDSCO |
| Japan | UNVERIFIED | UNVERIFIED | UNVERIFIED | PMDA |
| Singapore | UNVERIFIED | UNVERIFIED | UNVERIFIED | HSA |
| United Arab Emirates | UNVERIFIED | UNVERIFIED | UNVERIFIED | UNVERIFIED |
| Brazil | UNVERIFIED | UNVERIFIED | UNVERIFIED | ANVISA |
| Mexico | UNVERIFIED | UNVERIFIED | UNVERIFIED | COFEPRIS |
| New Zealand | UNVERIFIED | UNVERIFIED | UNVERIFIED | Medsafe |
Prescription status and controlled scheduling are separate regimes. Modafinil is prescription only everywhere it is marketed, and controlled in only some of those jurisdictions.
Armodafinil
| Jurisdiction | Marketed | Prescription required | Controlled scheduling |
|---|---|---|---|
| United States | Yes | Yes | Schedule IV |
| United Kingdom | No | n/a | n/a |
| Canada | No | n/a | n/a |
| Australia | UNVERIFIED | UNVERIFIED | UNVERIFIED |
| European Union | UNVERIFIED | UNVERIFIED | UNVERIFIED |
Armodafinil is not marketed in the United Kingdom or Canada. Where regulators in those countries issued pregnancy related communications addressing modafinil alone, the omission of armodafinil reflected its absence from the market rather than a safety judgement.
Solriamfetol and pitolisant
| Drug | Jurisdiction | Approved | Prescription required | Controlled scheduling |
|---|---|---|---|---|
| Solriamfetol | United States | Yes (2019) | Yes | Schedule IV |
| Solriamfetol | European Union | Yes | Yes | UNVERIFIED |
| Solriamfetol | Other | UNVERIFIED | UNVERIFIED | UNVERIFIED |
| Pitolisant | United States | Yes (2019) | Yes | Not scheduled |
| Pitolisant | European Union | Yes | Yes | UNVERIFIED |
| Pitolisant | Other | UNVERIFIED | UNVERIFIED | UNVERIFIED |
Pitolisant is not a controlled substance in the United States. It does not act on dopamine transporters and does not produce the reinforcing effects associated with stimulants.
Sodium oxybate
| Jurisdiction | Approved | Controlled scheduling | Distribution |
|---|---|---|---|
| United States | Yes | Schedule III | Restricted distribution programme |
| Other | UNVERIFIED | UNVERIFIED | UNVERIFIED |
Sodium oxybate is available in the United States only through a restricted distribution programme with certified prescribers and pharmacies. It cannot be filled at a standard retail pharmacy.
Amphetamines and methylphenidate
| Drug | United States | Other jurisdictions |
|---|---|---|
| Adderall (mixed amphetamine salts) | Schedule II, boxed warning | UNVERIFIED |
| Vyvanse (lisdexamfetamine) | Schedule II, boxed warning | UNVERIFIED |
| Methylphenidate | Schedule II | UNVERIFIED |
Change log
| Date | Change | Source |
|---|---|---|
| 11 August 2026 | Table created | FDA, DEA, MHRA, TGA, Health Canada |
Is prescription status the same as controlled scheduling?
No. They are separate questions. A drug can be prescription only without sitting under a controlled substances regime, which is the case for modafinil in several countries.
Is modafinil a controlled substance in the UK?
It is prescription only but not controlled under the Misuse of Drugs Act, unlike its Schedule IV status in the United States.
Is pitolisant scheduled in the United States?
No. It does not act on dopamine transporters and does not produce the reinforcing effects associated with stimulants.
Why are some cells marked unverified?
Because the entry could not be confirmed against the primary regulator. An unverified cell is marked rather than filled with a plausible guess.