At what age can Wellbutrin (bupropion) be started?

Wellbutrin (Bupropion) Age Guidelines

Wellbutrin is not FDA-approved for use in children under 18 years of age, and the FDA label explicitly states that safety and effectiveness in the pediatric population have not been established. 1

FDA-Approved Age Restrictions

• Bupropion has no established safety or efficacy data in patients under 18 years of age according to the FDA drug label 1
• The medication carries a black box warning about increased risk of suicidal thoughts and actions in children, teenagers, and young adults, particularly within the first few months of treatment 1

Off-Label Use in Clinical Practice

While not FDA-approved for pediatric use, bupropion has been studied and used off-label in children as young as 6 years of age for ADHD treatment:

Research Evidence for Pediatric Use

• The largest controlled trial included children aged 6-12 years with ADHD, demonstrating efficacy but with smaller effect sizes compared to methylphenidate 2
• A systematic review identified clinical trials involving children starting at age 6 years for ADHD management 3
• Recent utilization data shows bupropion is being prescribed to children aged 6-17 years in real-world practice, with depression (57%) and ADHD (25%) as the most common indications 4

Important Clinical Context

For ADHD specifically, bupropion should NOT be considered first-line or even second-line therapy in children. The American Academy of Pediatrics guidelines clearly establish the treatment hierarchy 5:

• Ages 4-5 years (preschool): Behavioral interventions first-line; methylphenidate only if behavioral interventions fail and moderate-to-severe dysfunction persists 5
• Ages 6-12 years (elementary/middle school): FDA-approved ADHD medications (stimulants) plus behavioral interventions as first-line 5
• Ages 12-18 years (adolescents): FDA-approved ADHD medications with behavioral interventions 5

Bupropion is positioned as a third-line or later option, considered only after stimulants and non-stimulant alternatives like atomoxetine, guanfacine, or clonidine 6

Special Considerations for Pediatric Use

When Bupropion Might Be Considered in Children

Bupropion may be particularly useful in specific clinical scenarios 6, 3, 7:

• Comorbid depression with ADHD in adolescents, where dual treatment is needed 6, 7
• Stimulant intolerance or contraindications (e.g., tics, severe anxiety, substance abuse concerns) 6, 3
• Comorbid conduct disorder or substance use disorders where stimulant diversion is a concern 3

Critical Safety Warnings for Pediatric Patients

Monitor closely for psychiatric adverse events 1, 4:

• Suicidal ideation was documented in 16.3% of children prior to bupropion initiation in recent utilization data 4
• Poisoning events occurred in 5.9% of pediatric patients 4
• Anorexia or bulimia nervosa was present in 2.2% of children starting bupropion 4

Dermatological reactions are more common in children 2:

• Rash and urticaria occurred twice as frequently in the drug group versus placebo 2
• Four serious reactions required medication discontinuation in the pivotal pediatric trial 2

Seizure risk requires careful dosing 1:

• Maximum dose should not exceed 450 mg/day 6
• Avoid in patients with seizure disorders, eating disorders, or abrupt discontinuation of alcohol/benzodiazepines 1

Practical Dosing for Pediatric Off-Label Use

If bupropion is prescribed off-label in children aged 6-17 years 2, 8:

• Starting dose: 1.4-3.0 mg/kg/day divided twice daily 2, 8
• Maintenance dose: 3.0-6.0 mg/kg/day (mean effective dose approximately 3.3 mg/kg/day) 2, 8
• Maximum dose: Do not exceed 6 mg/kg/day or 450 mg/day total 2
• Formulation: Sustained-release (SR) or extended-release (XL) formulations preferred for twice-daily or once-daily dosing 6, 7

Daily continuous dosing is required - unlike stimulants, bupropion cannot be used intermittently or "as needed" because it requires time to build therapeutic levels 6

Bottom Line for Clinical Practice

Start bupropion at age 18 years or older for FDA-approved indications (depression, smoking cessation). For patients under 18, bupropion remains off-label with the earliest research data supporting use at age 6 years, but only after exhausting preferred treatment options and with careful risk-benefit discussion including the lack of FDA approval, increased suicide risk monitoring, and need for subspecialty consultation when possible 5, 6, 1.