Safety of Varenicline for Smoking Cessation in Psychiatric and Addicts Patients

Subst Use Misuse. 2016;51(5):649-57. doi: 10.3109/10826084.2015.1133646. Epub 2016 Apr 6.


The safety of varenicline in the treatment of tobacco dependence has been questioned, in psychiatric patients. However, most published studies have not included psychiatric patients.

Objective: Assess the safety of varenicline for smoking cessation in patients with psychiatric disorders.

Methods: This is a prospective, longitudinal, multicenter study. The sample is composed of three groups (patients with psychotic disorder, patients with alcohol dependence disorder and patients addicts in methadone maintenance treatment). Patients were recruited consecutively between September 2008 and June 2009 from 11 centers. All patients received a standardized smoking cessation program with varenicline and psychological support. Adverse events of the drug were monitored at weeks 1, 2, 4, 6, 8, and 12 of treatment. Bivariate analysis has been used.

Results: None of the 90 patients included, presented a serious adverse event. The most frequent adverse effect was dry mouth (28.9%), followed by the presence of flatulence (27.8%), abnormal dreams (27.8%), and nausea (22%), especially between weeks 2 and 6 of treatment. None of the patients referred intense suicidal ideation, although two referred to moderate suicidal ideation, which was solved in one case and in the other, treatment was discontinued. Four participants (4.4%) abandoned treatment because of gastrointestinal symptoms. The initial dose of varenicline was reduced in 25% of patients during the study.

Conclusions: Gastrointestinal adverse events are the most incident in this sample of psychiatric patients and no exacerbation of psychiatric symptoms was detected, thus indicating a good safety record for varenicline use for smoking cessation in psychiatric patients.

Keywords: Smoking cessation; alcohol dependence; methadone treatment; psychotic disorder; varenicline.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Counseling
  • Female
  • Humans
  • Longitudinal Studies
  • Male
  • Mental Disorders
  • Middle Aged
  • Prospective Studies
  • Smoking / drug therapy*
  • Smoking Cessation / methods*
  • Substance-Related Disorders
  • Tobacco Use Cessation Devices / adverse effects*
  • Varenicline / adverse effects*
  • Varenicline / therapeutic use


  • Varenicline