Non-Stimulant Approved for ADHD

Nov. 26, 2002 -- The FDA today approved Strattera, the first non-stimulant drug for treating kids, teens, and adults with attention deficit hyperactivity disorder (ADHD).

There are already several drugs that control ADHD symptoms. All, however, are stimulants, such as Ritalin, Adderall, and Cylert. Many parents -- and doctors -- have been eagerly awaiting an alternative, says Christopher J. Kratochvil, MD, assistant director of the psychopharmacology research center at the University of Nebraska.

"This is the first nonstimulant medicine approved for use in ADHD -- it is certainly a significant event," Kratochvil tells WebMD. "All of our currently available medications -- the stimulants -- certainly have a robust effect. They are well studied, safe, and effective. But there are some drawbacks to the stimulants that have led us to look for alternatives for use in ADHD."

Kratochvil (pronounced KRA-tuh-vill) led some of the clinical trials that led to Strattera's approval. He says the new drug works about as well as Ritalin, although there have been no definitive head-to-head comparisons. It seems at least as safe. Strattera's manufacturer is Eli Lilly and Company, a WebMD sponsor.

One big advantage for Strattera is that it apparently can't be used as a drug of abuse. Stimulant drugs can be abused, forcing strict -- and, to parents, annoying -- prescription rules. This means that Strattera prescriptions can be refilled -- including over the phone.

The most common side effects in children and adolescents were decreased appetite, nausea, vomiting, tiredness, and upset stomach. In adults, the most common side effects were problems sleeping, dry mouth, decreased appetite, upset stomach, nausea and vomiting, dizziness, problems urinating, and sexual side effects.

Contrary to some of the stimulants used to treat ADHD, Strattera doesn't seem to cause wakefulness. Kratochvil says that though more studies are needed, Strattera might relieve ADHD symptoms not just during school hours, but all day.

"Many people forget that ADHD affects the entire life of child," he notes. "It can alienate children from their peers if they are too aggressive, if they say things without thinking. Their impulsivity can lead them to run out in front of traffic. When their medication wears off they may not be able to attend to homework. So we need to look at ways to treat the child throughout all aspects of their life. We do have data that Strattera can be dosed once a day. We need to look at how much time this can cover."

Strattera has a different effect on the brain from stimulant drugs. Unlike the stimulants, it affects only one major brain chemical, norepinephrine -- thought to be important in regulating attention, impulsivity, and activity levels.

As with any new drug for children, doctors are expected to be cautious in prescribing Strattera until it has an established track record. In fact, Strattera has not been tested in children under 6 years of age. But once they are comfortable with it, Kratochvil predicts, many will offer it as a drug of first choice.