FDA-Approved Indications for Adderall
Adderall (amphetamine and dextroamphetamine) is FDA-approved for two specific diagnoses: Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 3 years of age and older, and narcolepsy. 1
Primary Approved Indications
ADHD (Attention-Deficit/Hyperactivity Disorder)
- Adderall is approved for ADHD treatment in children aged 3 years and older, adolescents, and adults who meet full DSM-IV (or current DSM-5) diagnostic criteria for ADHD 2, 1
- The medication should only be prescribed when symptoms cause persistent significant impairment in at least one functional domain 2
- Critical caveat: Medication is not appropriate for children whose symptoms do not meet DSM criteria for ADHD diagnosis 3
- Treatment requires documented childhood onset and persistent symptoms for adult diagnosis 4
Narcolepsy
- Dextroamphetamine (a component of Adderall) is conditionally recommended for narcolepsy treatment in adults by the American Academy of Sleep Medicine 2
- Amphetamine formulations demonstrate clinically significant improvements in excessive daytime sleepiness and cataplexy in narcolepsy patients 2
- This is an FDA Schedule II controlled substance indication with specific monitoring requirements 2
Age-Specific Approval Parameters
Pediatric Use
- Not recommended for children under 3 years of age with ADHD 1
- For children 3 years and older, approval requires comprehensive diagnostic evaluation confirming DSM criteria 2, 3
- Growth monitoring is mandatory during treatment as data regarding chronic administration effects on growth inhibition remain inadequate 1
Adult Use
- Approved for adults with documented ADHD of childhood onset with persistent symptoms 4
- Also approved for adult narcolepsy at standard dosing of 5-60 mg daily 5
Important Prescribing Restrictions
Schedule II Controlled Substance Status:
- Carries FDA black box warning regarding high potential for abuse and dependence with prolonged administration 2, 1
- Requires careful patient selection and monitoring protocols 2
Pregnancy Considerations:
- Classified as Pregnancy Category C with demonstrated embryotoxic and teratogenic effects in animal studies 1
- May cause fetal harm based on animal data, though human data remain insufficient 2
- One case report documented severe congenital anomalies (VATER association) with first-trimester exposure 1
Contraindicated Populations:
- Not indicated when ADHD symptoms are associated with acute stress reactions rather than chronic ADHD 1
- Clinical evaluation must exclude tics and Tourette's syndrome before initiation, as amphetamines may exacerbate motor and phonic tics 1
- May exacerbate symptoms in psychotic patients 1
Off-Label Use Context
While Adderall is sometimes used off-label for conditions like treatment-resistant depression or cognitive enhancement, these are not FDA-approved indications 5. The only two approved diagnoses remain ADHD (ages 3+) and narcolepsy 1, 5.