148. Treatment Recommendations: Medications-Varenicline

Treating Tobacco Use and Dependence: 2008 Update

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Patient selection Appropriate as a first-line medication for treating tobacco use
Precautions, warnings, contraindications and side effects (see FDA package insert for complete list) Pregnancy-Pregnant smokers should be encouraged to quit without medication. Varenicline has not been shown to be effective for treating tobacco dependence in pregnant smokers. (Varenicline is an FDA pregnancy Class C agent.) Varenicline has not been evaluated in breast-feeding patients.

Cardiovascular diseases-Not contraindicated

Precautions-Use with caution in patients with significant kidney disease (creatinine clearance < 30mL/min) or who are on dialysis. Dose should be reduced with these patients. Patients taking varenicline may experience impairment of the ability to drive or operate heavy machinery.

Warning-In July, 2009, the FDA issued a boxed warning regarding the use of varenicline. Specifically, the use of varenicline has been associated with reports of changes in behavior such as hostility, agitation, depressed mood and suicidal thoughts or actions. The FDA is requiring the manufacturer of this product to add a new Boxed Warning to the product labeling to alert health care professionals to this important new safety information. People who are taking varenicline and experience any serious or unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their health care professional right away. See FDA.gov or package inserts for more information. In light of these FDA recommendations, clinicians should consider eliciting information on their patients' psychiatric history and monitoring for changes in mood and behavior.

Side effects-Nausea, trouble sleeping, abnormal/vivid/strange dreams.

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Page last reviewed October 2014
Page originally created September 2012
Internet Citation: 148. Treatment Recommendations: Medications-Varenicline. Content last reviewed October 2014. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/professionals/clinicians-providers/guidelines-recommendations/tobacco/clinicians/presentations/2008update-full/slide148.html