Adderall XR

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved October 2001

Specific Treatments:

Attention deficit/hyperactivity disorder (ADHD)

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General Information

Adderall XR, an extended release formulation of Shire's previously approved ADHD treatment Adderall, has been approved for treatment of ADHD in children. This once-daily capsule provides all day treatment with one morning dose, unlike most ADHD treatments that require a midday dose. This dosing regimen eliminates the social stigma issues felt by children having to bring medication to school and decreases the possibility of medication misuse.

ADHD is the most commonly diagnosed psychiatric disorder among school-aged children. Symptoms include inattentive, impulsive and hyperactive behavior that interferes with a child's ability to properly function in academic and social settings.

Clinical Results

Approval of Adderall XR is based on two clinical studies, involving more than 600 pediatric subjects at over 50 sites. Results from a laboratory classroom study showed that Adderall XR provided longer-lasting symptom control than the original Adderall. Adderall XR demonstrated statistically significant superiority in symptom control over placebo at all times observed from 1.5 to 12 hours after dosing. Symptoms included hyperactivity, impulsivity and the inability to work, focus and learn.

In a second clinical study, including more than 500 ADHD diagnosed children, a morning administration of Adderall XR was shown to provide as significant an improvement in attention and behavior at 4 p.m. as was observed at 10 a.m.

Side Effects

Adverse events associated with the use of Adderall XR may include (but are not limited to) the following:

  • Anorexia
  • Insomnia
  • Abdominal pain
  • Emotional lability
  • Nervousness

Mechanism of Action

Adderall XR is an amphetamine product that acts as a stimulant to the central nervous system. It is unknown through which mechanism amphetamines produce mental and behavioral effects in children.

Additional Information

For additional information on attention deficit/hyperactivity disorder, please visit