New Drug Approved for Treating Adult ADHD

Adderall XR Is 1st Stimulant Approved to Treat Adults With ADHD

Medically Reviewed by Brunilda Nazario, MD on August 13, 2004
From the WebMD Archives

Aug. 13, 2004 -- A drug already used to treat attention deficit hyperactivity disorder (ADHD) in children has now been approved for adults.

This week, the FDA approved Adderall XR to treat adults who suffer from the disorder. Researchers say it's the first stimulant ADHD medication to be specifically approved for treating adults.

However, many doctors have already been using stimulant medications, such as Adderall and Ritalin, to treats adults as an off-label use because few ADHD drugs have been studied in adults.

Researchers estimate that more than 8 million American adults may have symptoms of ADHD, such as inattention and impulsivity, but only about 600,000 are taking medication for the condition.

FDA Approves Adderall XR for Adults

The FDA based its approval on information from a four-week trial of Adderall XR in 248 adults. The results showed that a once-a-day dose of the drug provided benefits in reducing ADHD symptoms starting a week after treatment began and throughout the course of the study.

At the end of the study, ADHD symptom rating scores were 49% lower among adults who took Adderall compared with their scores at the start of the study.

Adderall's manufacturer, Shire Pharmaceuticals, recently published data on the long-term effects of Adderall XR use in adults, but this evidence has not been evaluated by the FDA.

The most common side effects of Adderall XR in adults are dry mouth, difficulty sleeping, dizziness, headache, loss of appetite, nausea, rapid heart rate, and weight loss.