Varenicline for smoking cessation: A narrative review of efficacy, adverse effects, use in at-risk populations, and adherence

Michael V. Burke, J. Taylor Hays, Jon O. Ebbert

Research output: Contribution to journalReview articlepeer-review

10 Scopus citations


Treating tobacco dependence is the most effective way to reduce tobacco-related death and disability. Counseling and pharmacotherapy have been shown to increase tobacco abstinence rates among smokers. Varenicline is the most effective monotherapy treatment for tobacco dependence; however, it is prescribed less often than indicated, and adherence is less than optimal. We conducted a literature review of the development, efficacy, safety, contraindications, and adverse effects of varenicline; including reviewing data regarding combination therapy, extended duration, and patient adherence. Varenicline was developed to work specifically on the factors that underlie nicotine addiction. Phase II and Phase III trials established dosing, safety profiles, and efficacy. Postmarketing research raised concerns about neuropsychiatric and cardiac effects, resulting in warning labels being added and modified to encourage discussions with patients weighing the risks and benefits. While more research is needed, evidence is strong that varenicline is safe and effective in treating tobacco dependence among people who are at higher risk for neuropsychiatric symptoms and cardiovascular disease. The effectiveness of varenicline can be improved by taking it in combination with other medications, enhancing patient adherence and extending the duration of treatment.

Original languageEnglish (US)
Pages (from-to)435-441
Number of pages7
JournalPatient Preference and Adherence
StatePublished - Apr 1 2016


  • Drug therapy
  • Medication adherence
  • Safety
  • Tobacco use
  • Tobacco use cessation
  • Treatment

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Social Sciences (miscellaneous)
  • Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
  • Health Policy


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