Modafinil, Armodafinil and Adrafinil: Prescription Status and Risks
Modafinil and armodafinil are prescription medicines for sleep disorders; adrafinil is a related substance. What regulators say, what research shows in healthy people, and the risks.
Content last updated . This page has not been medically reviewed.
This page is information only. It does not recommend these substances, suggest amounts or explain how to get them. A prescriber decides whether a medicine is right for a person. Never start, stop or change a prescribed medicine without talking to the prescriber.
Modafinil and armodafinil are prescription medicines. MedlinePlus describes them as used for excessive sleepiness caused by narcolepsy and shift work sleep disorder, and as part of treatment for obstructive sleep apnea [1][2]. They are not supplements. The MHRA said modafinil is licensed for specific medical conditions, not for use as a "boost" during exams [3]. Adrafinil is a different, related substance; see below. For narcolepsy itself, see Narcolepsy and Hypersomnia.
Prescription status by country (what we could read)
Rules change; this is a snapshot of pages read on 2026-10-23.
| Question | What we found | Body, country, year |
|---|---|---|
| United States: drug status | MedlinePlus lists modafinil and armodafinil as prescribed medicines for sleep conditions [1][2]. A Drugs@FDA data search found records for modafinil [4] and none for adrafinil [5]. | MedlinePlus, 2023-2024; FDA data via openFDA, 2026 |
| United States: controlled substance | The federal Schedule IV list includes modafinil [6]. Armodafinil is not named separately in the section we read, so we make no statement about it. Adrafinil is not named in that Schedule IV section [6] or in Schedule II [7]. | 21 CFR 1308.14, current to October 2026 |
| United States: sharing | MedlinePlus says selling or giving away modafinil is against the law [1]. | MedlinePlus, 2024 |
| United Kingdom | The MHRA said modafinil is a prescription-only medicine licensed only for narcolepsy [8], and that it is a criminal offence to supply prescription-only medicines without a valid prescription [3]. | MHRA, 2016 and 2020 |
| European Union | An MHRA safety update reported that the European Medicines Agency recommended modafinil be restricted to sleepiness associated with narcolepsy [9]. | MHRA reporting EMA, 2010 |
| Canada | A Health Canada Drug Product Database record for a modafinil product lists the schedule as "PRESCRIPTION" [10]. | Health Canada, 2026 |
| Australia | Could not be verified from pages we read. | Not available |
The UK government's drug advisers invited evidence in 2020 on non-medical use of modafinil, methylphenidate and dexamfetamine, which they called "cognition enhancers" [11].
What does research show for healthy people?
Evidence labels used here: "mixed" and "insufficient evidence". People with narcolepsy, sleep-deprived workers and healthy rested students are different groups, so results do not transfer between them.
- Healthy, not sleep-deprived adults: mixed, small effects. A 2020 set of meta-analyses (47 studies across three drugs) found an overall effect of modafinil on cognitive tasks of SMD 0.12 [12]. The authors wrote that data on these stimulants is far from positive, and that a user perception of effectiveness is not supported by the evidence so far [12].
- Systematic review. A 2015 review found that most studies using basic tests showed some benefit for executive function, but only half showed improvements in attention and learning and memory, and a few reported impairments in divergent creative thinking [13]. It also noted methodological discrepancies across the literature [13].
- Short laboratory tasks are not the same as everyday school or work performance.
Risks (from the sources we read)
- Habit-forming. MedlinePlus says modafinil may be habit-forming [1] and armodafinil may be habit forming [2]. It also says modafinil should not be used in place of getting enough sleep [1].
- Serious reactions. MedlinePlus lists rash, blisters, chest pain, fast or irregular heartbeat, hallucinations, anxiety, depression and thinking about harming yourself as reasons to call a doctor immediately [1]. The MHRA likewise listed psychiatric disorders, serious skin reactions and cardiovascular disorders [8]. If you are in crisis in the US, call or text 988.
- Heart, liver, kidney, mental health history. MedlinePlus says to tell the doctor about heart, liver or kidney disease and mental illness [1].
- Pregnancy and contraception. The MHRA reported an approximate 15% likelihood of birth defects when modafinil is taken in pregnancy, compared with 3% in the general population, and said it can reduce the effectiveness of many hormonal contraceptives [8]. MedlinePlus says to tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding [1]. See Pregnancy and Breastfeeding.
- Interactions and surgery. MedlinePlus names omeprazole as an example that may interact [1] and asks you to tell any surgeon or dentist you take modafinil [1]. See Medication Interactions.
- Driving. MedlinePlus says not to drive or operate machinery until you know how the medicine affects you [1].
- Buying without a prescription. The MHRA warned that a huge number of medicines bought online are counterfeit, substandard or adulterated [14]. Products sold outside the prescription system may not contain what the label says.
- Overdose. MedlinePlus says to call poison control at 1-800-222-1222 [1]. In an emergency call 911.
- Children and older adults: not covered in the sources we read; ask the prescriber.
Adrafinil
Adrafinil is described in a research paper as a vigilance-promoting agent of the same pharmacological class as modafinil, with a first reported case of abnormal mouth and face movements (dyskinesia) that did not recover for 4 months after it was stopped [15]. A forensic paper says it is primarily metabolized in the body to modafinil [16], and that the World Anti-Doping Agency banned both in sport in 2004 [16]. We found no regulator page on adrafinil to read. A US Drugs@FDA search returned no match [5], and we make no legal claim beyond that. Proper evidence not found for adrafinil as a safe cognitive aid; we searched PubMed for "adrafinil".
If you are thinking about it
If sleepiness or poor focus is the problem, a clinician can look for causes such as sleep apnea, medicines or ADHD; see Sleep Safety and When to Get Help and ADHD in Adults. For students and workplaces, see Non-Prescribed Stimulant Use in Students and Workplaces.
Frequently asked questions
Is modafinil a prescription medicine?
Yes, in the sources we read: MedlinePlus describes it as prescribed for sleep conditions [1], the MHRA calls it prescription-only [8], and a Health Canada record lists the schedule as prescription [10].
Is modafinil a controlled substance in the United States?
The federal Schedule IV list in 21 CFR 1308.14 includes modafinil [6].
Can you get modafinil without a prescription legally?
We found statements that supplying it without a prescription is an offence in the UK [3] and that selling or giving it away is against the law in the US [1]. We give no advice on obtaining it. A prescriber can discuss options.
Does modafinil improve focus in healthy people?
Results are mixed and small. A 2020 meta-analysis found an overall modafinil effect of SMD 0.12 on cognitive tests in healthy non-sleep-deprived adults [12], and the authors said user perceptions are not supported by the evidence so far [12].
Is adrafinil the same as modafinil?
No, but the body converts adrafinil mainly to modafinil [16]. Adrafinil has its own risks, including a reported case of dyskinesia [15]. Neither should be started without a prescriber's advice.
References
- MedlinePlus (U.S. National Library of Medicine), Modafinil, last revised 07/20/2024. Read 2026-10-23.
- MedlinePlus, Armodafinil, last revised 10/15/2023. Read 2026-10-23.
- MHRA, Freshers warned to be smart and avoid Modafinil, September 26, 2016. Read 2026-10-23.
- openFDA Drugs@FDA data, search for products with the active ingredient modafinil, run 2026-10-23. Read 2026-10-23.
- openFDA Drugs@FDA data, search for products with the active ingredient adrafinil (no matches), run 2026-10-23. Read 2026-10-23.
- U.S. Code of Federal Regulations, 21 CFR 1308.14 (Schedule IV), eCFR current to 2026-10-21. Read 2026-10-23.
- U.S. Code of Federal Regulations, 21 CFR 1308.12 (Schedule II), eCFR current to 2026-10-21. Read 2026-10-23.
- MHRA, Sleep disorder drug modafinil linked to increased risk of birth defects and also to reduced effectiveness of contraception, November 16, 2020. Read 2026-10-23.
- MHRA Drug Safety Update, Modafinil: restricted use recommended (article dated August 2010). Read 2026-10-23.
- Health Canada Drug Product Database, schedule record for a modafinil product, run 2026-10-23. Read 2026-10-23.
- UK Advisory Council on the Misuse of Drugs, ACMD public evidence request on cognition enhancers, July 6, 2020. Read 2026-10-23.
- Roberts CA, et al. How effective are pharmaceuticals for cognitive enhancement in healthy adults? A series of meta-analyses. Eur Neuropsychopharmacol. 2020 (abstract). Read 2026-10-23.
- Battleday RM, Brem AK. Modafinil for cognitive neuroenhancement in healthy non-sleep-deprived subjects: a systematic review. Eur Neuropsychopharmacol. 2015 (abstract). Read 2026-10-23.
- UK Medicines and Healthcare products Regulatory Agency (MHRA), Medicines watchdog makes record seizure of experimental smart drugs, October 24, 2014. Read 2026-10-23.
- Adrafinil-induced orofacial dyskinesia. Mov Disord. 2004 (case report abstract). Read 2026-10-23.
- Identification of adrafinil and its main metabolite modafinil in human hair. Forensic Sci Res. 2020 (abstract). Read 2026-10-23.