Here is a new study is just out in the journal Pediatrics using the new formulation of modafinil for ADHD in children (age 6-17) (a formulation for which Cephalon is seeking FDA approval in children). Modafinil is a “wake promoting” drug that is thought to be nonaddictive. The clinical experience in children is growing, but is still limited.
In this study, children taking the modafinil showed significant improvements in behavior and no change in any measure of blood chemistry, heart rate, blood pressure, etc. Side effects were insomnia (doses were up to 425 mg/day) and headache. Another difference was that children treated with modafinil lost a small but significant amount of weight (not likely too much of a concern in PWS!). These larger studies showing safety and efficacy in children should be helpful for those who are discussing with their doctors the use of modafinil in children with PWS.
Efficacy and Safety of Modafinil Filmâ€“Coated Tablets in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder: Results of a Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study. Biederman J, Swanson JM, Wigal SB, Kratochvil CJ, Boellner SW, Earl CQ, Jiang J, Greenhill L. Pediatrics. 2005 Dec;116(6):e777-84