Can a 5-year-old take Strattera (atomoxetine) for Attention Deficit Hyperactivity Disorder (ADHD)?

Strattera (Atomoxetine) for a 5-Year-Old Child

Strattera is NOT FDA-approved for children under 6 years of age, and current clinical guidelines do not support its use in 5-year-olds with ADHD. 1

Why Insurance is Denying Coverage

• Atomoxetine has not been studied in children less than 6 years old, as explicitly stated in the FDA labeling 1
• The medication lacks safety and efficacy data for this age group, making it an off-label use with unknown risks 1
• Insurance companies typically deny coverage for medications used outside their FDA-approved age indications, particularly when evidence-based alternatives exist

What IS Recommended for a 5-Year-Old with ADHD

First-Line Treatment: Behavioral Therapy Alone

For preschool-aged children (4-5 years), evidence-based parent- and/or teacher-administered behavioral therapy should be the initial treatment. 2, 3

Behavioral therapy should be tried first because:

• Many preschoolers (4-5 years) experience significant improvements with behavioral interventions alone 2
• The overall evidence for parent training and behavioral management (PTBM) in preschoolers is strong 2
• These interventions avoid medication-related risks during a critical developmental period 2

When Medication May Be Considered

Medication should only be considered if ALL three criteria are met: 2

1. Symptoms have persisted for at least 9 months
2. Dysfunction is manifested in both home AND other settings (such as preschool or childcare)
3. Dysfunction has not responded adequately to behavioral therapy

Additionally, the child must have moderate-to-severe dysfunction, not mild symptoms 2

Medication Options for 5-Year-Olds (If Criteria Met)

If behavioral therapy fails and criteria are met, methylphenidate is the only medication with adequate evidence in this age group. 2

• Methylphenidate has moderate evidence for safety and efficacy in preschoolers from one multisite study of 165 children and 10 smaller studies (total 269 children) 2
• Methylphenidate use in 4-5 year-olds remains off-label despite the evidence 2
• Dextroamphetamine is the only FDA-approved medication for children under 6, but this approval was based on less stringent historical criteria rather than empirical evidence, and it cannot be recommended due to insufficient safety/efficacy data 2
• Other stimulant or nonstimulant medications (including atomoxetine/Strattera) have not been adequately studied in children in this age group 2

Important Dosing Considerations for Preschoolers

If methylphenidate is prescribed:

• Children 4-5 years metabolize stimulants more slowly than older children 2
• Start with lower doses and increase in smaller increments 2
• Maximum doses have not been adequately studied in this age group 2

Clinical Approach to Insurance Denial

What to Tell the Family

The insurance denial is medically appropriate because Strattera is not approved or studied in 5-year-olds. 1

Recommended Next Steps

1. Ensure adequate behavioral therapy trial first - This is the evidence-based first-line treatment and may resolve the issue without medication 2, 3

2. If medication is truly needed (meeting all three severity criteria above), consider methylphenidate instead, which has the best available evidence for this age group 2

3. Consult with a mental health specialist experienced with preschool-aged children if possible, particularly before initiating any medication 2

4. Weigh risks versus benefits carefully - Consider the developmental impairment, safety risks, or consequences for school/social participation that could occur if medications are not initiated versus the risks of early medication exposure 2

Common Pitfalls to Avoid

• Do not prescribe atomoxetine off-label to children under 6 - There is no safety or efficacy data, and better-studied alternatives exist 2, 1
• Do not skip behavioral therapy - It is the evidence-based first-line treatment and many children respond adequately without medication 2
• Do not use medication for mild symptoms - Only moderate-to-severe dysfunction warrants medication consideration in this age group 2
• Do not assume FDA approval equals evidence - Dextroamphetamine is FDA-approved for under 6 but lacks adequate evidence and cannot be recommended 2