Modafinil is approved for daytime sleepiness from conditions such as narcolepsy and obstructive sleep apnea. The drug will be sold as Sparlon for treating ADHD. A company spokesperson tells WebMD that it should be commercially available in just a few months pending final approval by the FDA.
Drug vs. Placebo
The ADHD drug will be sold in incremental dosages of 85 milligrams each to allow accurate once-a-day dosing. A typical dose will be 340 milligrams or 425 milligrams, depending on the patient's weight.
The newly reported study included 248 ADHD patients between the ages of 6 and 17, treated with modafinil or placebo (fake pill). Neither the patients nor their doctors knew which treatment the patient was getting.
Writing in the Dec. 6 issue of the journal Pediatrics, researchers reported that the modafinil-treated patients showed significantly greater improvements in ADHD symptoms.
By the end of the nine-week treatment period, almost half of the modafinil-treated patients (48%) were rated by their doctors as "much" or "very much" improved, compared with 17% of the placebo-treated patients.
The main side effects noted that differed significantly from those given placebo were insomnia (29%) and decrease in appetite (16%).
"Children and adolescents treated with once-daily (modafinil) showed improvement in ADHD symptoms, including inattention, impulsivity, and hyperactivity, both at school and at home," researcher Joseph Biederman, MD, says in a news release. Biederman is chief of the department of pediatric psychopharmacology at Boston's Massachusetts General Hospital.
Better or Worse?
The study was paid for by modafinil manufacturer Cephalon Inc. In all, more than 600 children and teens with ADHD have been treated with the drug in company-sponsored trials.
"We don't yet know if modafinil is any better or worse than these medications," ADHD treatment expert James T. Perrin, MD, tells WebMD. "What we do know is that this medication does seem to work in children with ADHD in the usual ways."
Perrin directs the Mass General Hospital for Children. He was not involved with this study.
Although also a stimulant, modafinil appears to have a lower potential for abuse than other ADHD stimulant drugs. But Perrin says abuse has not proved to be a problem in children and teens treated with the available drugs.
He adds that the search for new treatments for ADHD is appropriate because none of the current drugs is perfect.
"There is no question that the drugs we use today are effective, and these trials suggest that modafinil is also effective," he says. "But it is important to point out that none of these drugs make kids with ADHD fully normal. We have further to go to get there than any of these medications can take us."