What is the efficacy of Bupropion (Zyban) for smoking cessation in pediatric populations?

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Last updated: April 19, 2025View editorial policy

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From the Guidelines

Bupropion is not recommended for smoking cessation in children and adolescents under 18 years of age. The FDA has not approved bupropion (Zyban) for smoking cessation in pediatric populations, and clinical evidence supporting its safety and efficacy in this age group is limited, as noted in a study published in the Annals of Internal Medicine 1. For adolescents who smoke, first-line approaches should focus on behavioral interventions, counseling, and motivational interviewing. Some evidence suggests that school- and community-based behavioral counseling programs can promote smoking cessation in adolescent smokers, with a meta-analysis of 64 trials showing a 4–percentage point difference in smoking cessation rates between the intervention and control groups 1. If pharmacotherapy is considered necessary for older adolescents with significant nicotine dependence, it should only be used under close medical supervision, with careful consideration of risks versus benefits. Bupropion carries a black box warning regarding increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults, making it particularly concerning for pediatric use. Key considerations for smoking cessation in children and adolescents include:

  • Behavioral interventions, such as counseling and motivational interviewing
  • School- and community-based programs
  • Family-based interventions
  • Cognitive behavioral therapy
  • Mobile phone–based interventions for tobacco cessation, as recommended by the Community Preventive Services Task Force 1.

From the Research

Bupropion Smoking Cessation in Children

  • Bupropion is a medication that has been studied for its effectiveness in smoking cessation, including in adolescents 2, 3.
  • A study published in 2011 found that combined bupropion SR and contingency management treatment yielded significantly superior abstinence rates during active treatment when compared with placebo + non-CM treatment in adolescent smokers 2.
  • Another study published in 2021 noted that bupropion appears to be more effective than other pharmacologic options in improving abstinence among adolescents who smoke in the short term, but it is not approved by Health Canada for those younger than 18 years 3.
  • The safety of bupropion for smoking cessation in adolescents has also been studied, with one review finding that bupropion has not been associated with an increase in adverse events in smoking cessation trials 3.
  • However, more research is needed on the long-term effectiveness and safety of bupropion in this population 3.

Comparison with Other Treatments

  • Bupropion has been compared to other pharmacotherapies for smoking cessation, including varenicline 4.
  • A review of research published in 2024 found that varenicline seems to be more effective in maintaining abstinence and reducing craving than bupropion and nicotine replacement therapy 4.
  • However, bupropion is still considered a first-line medication for smoking cessation in adults, and its efficacy and safety have been established in clinical trials and postmarketing experience 5.

Efficacy and Safety

  • Bupropion SR has been found to be more effective than placebo at improving initial and long-term abstinence rates and preventing relapse in clinical trials 5.
  • The most common adverse event associated with bupropion SR is insomnia, which can also be a symptom of nicotine withdrawal 5.
  • The main risks of treatment with bupropion SR are major motor seizure and hypersensitivity reaction, but these are rare 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Bupropion SR and contingency management for adolescent smoking cessation.

Journal of substance abuse treatment, 2011

Research

Bupropion for smoking cessation in adolescents.

Canadian family physician Medecin de famille canadien, 2021

Research

Smoking cessation pharmacotherapy; varenicline or bupropion?

Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2024

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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