Is Vyvanse (lisdexamfetamine) appropriate for a 5‑year‑old child?

Vyvanse Use in a 5-Year-Old Child

Vyvanse (lisdexamfetamine) is not appropriate for a 5-year-old child, as it is not FDA-approved below age 6 years and lacks any safety or efficacy data in preschool-aged children. 1

FDA Approval and Age Restrictions

• Lisdexamfetamine is FDA-approved only for children aged 6 years and older for ADHD treatment 1, 2, 3
• The FDA drug label explicitly states that "lisdexamfetamine dimesylate capsules are not approved for use in pediatric patients below 6 years of age" 1
• No clinical trials have evaluated lisdexamfetamine in preschool-aged children (4-5 years old) 2, 3, 4

Appropriate Medication Options for Preschool-Aged Children (4-5 Years)

If medication is necessary for a 5-year-old with ADHD, methylphenidate is the only stimulant with adequate evidence, though it remains off-label. 5, 6

Prerequisites Before Considering Any Medication at Age 5:

1. Symptoms must have persisted for at least 9 months 5, 6
2. Dysfunction must be present in both home AND other settings (e.g., preschool, daycare) 5, 6
3. Moderate-to-severe functional impairment must be documented 5
4. Behavior therapy must have been tried first and failed to provide adequate improvement 5

Why Methylphenidate Over Other Stimulants for Age 5:

• Methylphenidate has moderate evidence from 1 multisite study (165 children) plus 10 smaller studies (total 269 preschool-aged children), with 7 of 10 single-site studies showing efficacy 5
• Dextroamphetamine has FDA approval for children under 6 years, but this approval was based on outdated criteria without empirical evidence—making it inappropriate despite its "on-label" status 5, 7
• Lisdexamfetamine (Vyvanse) has zero evidence in preschool-aged children and should never be used 1, 2

Special Dosing Considerations for Preschool-Aged Children:

• Children aged 4-5 years metabolize stimulants more slowly than older children 5
• Start with lower doses and increase in smaller increments compared to school-aged children 5, 6
• Maximum doses have not been adequately studied in this age group 5

Common Pitfalls to Avoid

• Never prescribe Vyvanse to a child under 6 years old—this is off-label use without any supporting evidence and violates FDA approval 1
• Do not use dextroamphetamine in preschoolers despite its FDA approval, as the approval predates modern evidence standards 5, 7
• Do not prescribe stimulants for preschoolers with mild ADHD symptoms—only moderate-to-severe dysfunction warrants medication at this age 5
• Do not skip behavior therapy first—it is the primary treatment for preschool-aged ADHD, and medication should only be added if behavior therapy fails 5

Why Behavior Therapy Must Come First in Preschoolers

• Many young children (4-5 years) experience significant symptom improvement with behavior therapy alone 5
• There are concerns about effects on growth during this rapid developmental period 5
• Limited long-term safety data exists for stimulant use in preschool-aged children 5
• Behavior therapy does not require a specific diagnosis and has been proven effective in this age group 5

Bottom Line Algorithm for a 5-Year-Old

1. Confirm ADHD diagnosis meets DSM-5 criteria with moderate-to-severe impairment 5
2. Implement parent training in behavior therapy for at least 9 months 5
3. If behavior therapy fails and dysfunction persists in multiple settings, consider methylphenidate (off-label) 5, 6
4. Start methylphenidate at low doses (lower than school-aged children) and titrate slowly 5
5. Never use Vyvanse—wait until the child turns 6 years old 1, 2