At what age can Wellbutrin (bupropion) be prescribed to pediatric patients?

Pediatric Age for Wellbutrin (Bupropion)

Bupropion is not FDA-approved for use in children under 18 years of age, and the FDA drug label explicitly states "It is not known if bupropion hydrochloride extended-release tablets (XL) are safe and effective in children under the age of 18." 1

FDA Regulatory Status

• The FDA has not approved bupropion for any indication in pediatric patients under 18 years, emphasizing that safety and efficacy have not been established in this age group 1
• This lack of approval means any use in children represents off-label prescribing, which carries additional responsibility for informed consent and monitoring 1

Off-Label Use in Clinical Practice

Despite the lack of FDA approval, bupropion is prescribed off-label to children and adolescents in the United States, primarily for two indications:

ADHD Treatment

• Children aged 6-12 years have been studied in clinical trials, with a landmark multisite, double-blind, placebo-controlled trial demonstrating efficacy at doses of 3-6 mg/kg per day administered twice daily 2
• Depression is the most common potential indication (57% of pediatric prescriptions), followed by ADHD (25% of pediatric prescriptions) in real-world practice 3
• Systematic reviews confirm that bupropion shows efficacy for ADHD in children and adolescents, though effect sizes are somewhat smaller than standard stimulants like methylphenidate 4
• Head-to-head trials found comparable efficacy between bupropion (100-150 mg/day based on weight) and methylphenidate (20-30 mg/day) in children and adolescents with ADHD 5

Comorbid ADHD and Depression

• Adolescents aged 11-16 years with comorbid ADHD and depression showed 58% response rates for both conditions when treated with bupropion SR at flexibly titrated doses up to 3 mg/kg twice daily 6
• This represents a particularly important clinical scenario where bupropion may offer advantages over stimulants alone 6

Critical Safety Warnings for Pediatric Use

Black Box Warning: Suicidality

• Antidepressant medicines, including bupropion, may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults within the first few months of treatment 1
• Close monitoring is mandatory, particularly for new or worsening depression, anxiety, agitation, panic attacks, irritability, aggression, or suicidal ideation 1
• Families must be educated to report sudden changes in mood, behavior, thoughts, or feelings immediately 1

Seizure Risk

• There is an inherent seizure risk with bupropion that requires particular caution in pediatric populations 1
• Four serious dermatological reactions (rash and urticaria) requiring medication discontinuation occurred in the pediatric ADHD trial, appearing twice as frequently as in the placebo group 2

High-Risk Pediatric Presentations

• Real-world data show that 16.3% of children prescribed bupropion had suicidal ideation, 5.9% had poisoning diagnoses, and 2.2% had anorexia or bulimia nervosa prior to initiation 3
• These high-risk presentations demand extremely careful risk-benefit assessment and intensive monitoring 3

Practical Prescribing Considerations When Used Off-Label

Dosing in Children (Ages 6-12)

• Start at 3 mg/kg per day divided twice daily (7 AM and 7 PM dosing schedule used in trials) 2
• Maximum studied dose is 6 mg/kg per day 2
• Extended-release 24-hour 150 mg formulation is most commonly prescribed (62% of initiations) 3

Dosing in Adolescents (Ages 11-16)

• Bupropion SR can be flexibly titrated up to 3 mg/kg twice daily 6
• Weight-based dosing: 100 mg/day for patients <30 kg; 150 mg/day for patients >30 kg 5

Monitoring Requirements

• Weekly assessment of height, weight, vital signs, and adverse experiences during titration 2
• Baseline and follow-up physical examinations, ECG, EEG, and laboratory evaluations 2
• Continuous vigilance for behavioral changes, particularly suicidality, throughout treatment 1
• Only 39-45% of pediatric patients remain on bupropion for at least 6 months, indicating frequent discontinuation 3

Clinical Decision Algorithm

When considering bupropion in a patient under 18:

1. Confirm the patient is at least 6 years old - no data exist for children younger than 6 years 2
2. Assess for absolute contraindications - active suicidal ideation, seizure history, eating disorders, or abrupt discontinuation of alcohol/benzodiazepines 1
3. Evaluate whether FDA-approved alternatives have been tried or are contraindicated - stimulants remain first-line for ADHD; SSRIs remain first-line for depression 4
4. Consider bupropion specifically when:
   • ADHD coexists with depression requiring treatment 6
   • Stimulants have failed or are contraindicated 4
   • Comorbid substance use disorders exist (though this requires subspecialist involvement) 4
5. Obtain informed consent explicitly discussing off-label use, black box warnings, and the need for intensive monitoring 1
6. Implement weekly monitoring for the first month, then biweekly, with clear family education about warning signs 1, 2

Important Caveats

• The evidence base for pediatric bupropion use is limited, with only six clinical trials involving children identified in systematic reviews 4
• Teacher ratings showed smaller treatment effects than parent ratings in the pivotal trial, suggesting variable response across settings 2
• Concurrent SSRI use occurs in 22% of pediatric bupropion initiators, raising concerns about polypharmacy and drug interactions 3
• Bupropion should never be considered a first-line agent in pediatric populations given the lack of FDA approval and the availability of better-studied alternatives 1, 4