PROVIGIL remains the first and only FDA-approved medication to promote wakefulness. It is prescribed for excessive sleepiness associated with serious medical conditions affecting millions of people. PROVIGIL has generated nearly 10 million prescriptions and over $2 billion in cumulative revenue since its U.S. launch in 1999.

The Fall 2007 issue of the FDA Drug Safety newsletter notes: "FDA has been monitoring cases of serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), in its post marketing reviews of adverse event reports associated with the use of modafinil." The labeling on Provigil was recently updated to include a warning about serious skin rash as a side effect.

A serious rash or serious allergic reaction
- Especially including SJS or TEN
- Including rash, hives, sores in the mouth or skin, blisters and peels, swelling of the face, eyes, lips, tongue, or throat, trouble swallowing or breathing and hoarse voice.

Mental (psychotic/psychiatric) symptoms.
- Such as suicidal ideations or suicide attempts.