Is Modafinil a Controlled Substance? US, UK, Canada, and EU Status

Is modafinil a controlled substance in the United States?

Yes. The controlled-substance section of the Provigil label states that the product contains modafinil, a Schedule IV controlled substance [1]. It is a prescription medicine, not an uncontrolled or over-the-counter product, and it is Schedule IV rather than Schedule II [1].

What does the label say about abuse and dependence?

In an inpatient study in people experienced with drugs of abuse, modafinil 200, 400 and 800 mg produced psychoactive and euphoric effects and feelings consistent with other scheduled CNS stimulants, assessed against methylphenidate 45 and 90 mg [1]. Modafinil is reinforcing: monkeys trained to self-administer cocaine will self-administer it [1]. The label tells prescribers to follow patients closely, particularly those with a history of drug or stimulant (methylphenidate, amphetamine, cocaine) abuse, and to watch for misuse such as increasing doses or drug-seeking behavior [1].

On dependence, one placebo-controlled trial followed people after 9 weeks of modafinil use: no withdrawal symptoms were reported during 14 days of observation, although sleepiness returned in patients with narcolepsy [1].

How does modafinil compare with amphetamine?

The label says the mechanism by which modafinil promotes wakefulness is unknown. Its wake-promoting actions are similar to sympathomimetics such as amphetamine and methylphenidate, but its pharmacologic profile is not identical to theirs [1]. In vitro it binds the dopamine transporter and inhibits dopamine reuptake, and it raised extracellular dopamine in some animal brain regions [1].

What is modafinil approved to treat in the US?

Three adult indications: excessive sleepiness with narcolepsy, with obstructive sleep apnea, or with shift work disorder [1]. In OSA the label is explicit that modafinil treats the sleepiness and not the airway obstruction, and that a maximal effort at CPAP should be made before and during treatment [1]. It is not approved for pediatric patients for any indication [1]. ADHD, depression, fatigue from other conditions such as multiple sclerosis, jet lag and cognitive enhancement in healthy people are off-label uses [1].

Provigil (NDA 020717) was first approved on 24 December 1998 [4]; Nuvigil (armodafinil, NDA 021875) on 15 June 2007 [3].

Is armodafinil controlled too?

Yes. Armodafinil is sold as Nuvigil under its own approval, NDA 021875, granted in 2007 [3]. It is the R-enantiomer of modafinil, and modafinil itself is a 1:1 racemic mixture of the two enantiomers [1][3]. Armodafinil is also a Schedule IV controlled substance [1].

Is modafinil banned in sport?

Yes, in-competition. The WADA 2026 Prohibited List names modafinil in S6.A non-specified stimulants, prohibited in-competition, alongside adrafinil, flmodafinil and fladrafinil [2]. The List states that all stimulants, including all optical isomers, are prohibited [2]. Armodafinil is not named separately, but as the R-enantiomer, an optical isomer, of modafinil, athletes should treat it as prohibited and check with their anti-doping organization [2]. The 2027 List, in force from 1 January 2027, still names modafinil in S6.A [5]. A prescription alone is not enough in WADA-governed sport; a Therapeutic Use Exemption is needed [2].

What about the UK, Canada and the EU?

This page covers the US federal position, Schedule IV and prescription-only [1], and the WADA list. The indications described above are the FDA-approved ones; other countries set their own labels and their own classifications.