Provigil is used to treat excessive sleepiness in adults with certain sleep disorders. In addition, it was thought that Provigil might be approved to treat children and teens with ADHD in a new dosage form under the name Attenace or Sparlon.
Unfortunately, in August of 2006, the FDA sent a letter to Cephalon stating that Sparlon was not approvable to treat children with ADHD because of a single case of Stevens Johnson syndrome.
Provigil is currently approved to treat excessive sleepiness in adults with narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Since 'some effects of Provigil on the brain are similar to other medications called "stimulants",' it shouldn't be a surprise that Provigil might also work for treating ADHD.
- the main ingredient in Provigil is modafinil
- Provigil is a controlled substance (Class IV), while stimulants are a Class II controlled substance
- like most other popular ADHD medications, Provigil can be given just once a day
Provigil is currently available in 100mg and 200mg capsules. If had been approved for treating children with ADHD, new higher dosage forms would likely have become available.
In the Biederman modafinil study, the most common side effects in children treated with modafinil or Provigil included insomnia, headache, and decreased appetite. Other known side effects of Provigil when used to treat sleep disorders can include headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness, and upset stomach.
Provigil will not be approved to treat children with ADHD.
- Rugino TA. Modafinil in children with attention-deficit hyperactivity disorder. Pediatr Neurol - 01-AUG-2003; 29(2): 136-42
- Biederman J. Efficacy and safety of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder: results of a randomized, double-blind, placebo-controlled, flexible-dose study. Pediatrics. 01-DEC-2005; 116(6): e777-84
- Provigil Patient Information Leaflet. December 2004.
