Modafinil Reference

Plain English

What it is

Modafinil (brand name Provigil) is a prescription medicine that the FDA approved to help adults stay awake. It is approved for excessive sleepiness caused by narcolepsy, shift-work sleep disorder, and obstructive sleep apnea (a breathing problem during sleep).

What people use it for

Outside its approved sleep uses, it is one of the most talked-about off-label 'smart drugs' that people use to feel focused and alert during long stretches of work. That focus use is not what the FDA approved it for.

What the science shows

The evidence is strong for the approved sleepiness conditions. For sharpening thinking in healthy people the studies are small, and this remains an unapproved use.

The catch

Modafinil is a Schedule IV controlled substance, so it is regulated and available only with a prescription. Its label also warns of rare but serious skin reactions, including Stevens-Johnson syndrome, that have led to hospitalization.

Reference summary

Modafinil is label-verified for the listed sleep-medicine indications. Off-label cognitive-enhancement use is studied in small trials; off-label use is outside the approved indication.

Regulatory and posture

Categories

Nootropic

Aliases

Provigil, Modalert, Modvigil

Evidence posture

human - FDA-approved Schedule IV controlled substance for narcolepsy / shift-work sleep disorder / obstructive sleep apnea. Off-label cognitive-enhancement use is outside the approved indication. Possession without a prescription is a federal offense.

Regulatory status

FDA-approved prescription medication (Provigil). Indicated for narcolepsy, shift-work sleep disorder, and obstructive sleep apnea (as adjunct). Schedule IV controlled substance under the federal Controlled Substances Act.

Content review status

label verified