Varenicline Fact Sheet

(var-EN-nik-lin)

Varenicline is a quit-smoking medication approved for use by the FDA. It is available by prescription only.

How it Works

Varenicline acts differently than the other cessation medications. It is neither a nicotine replacement therapy nor an anti-depressant drug. Varenicline acts on nicotine receptors with two types of action: It blocks some of the rewarding effects of nicotine (acts as an antagonist) and at the same time stimulates the receptors in a way that reduces withdrawal (acts as an agonist). Varenicline offers another option for smokers and those who treat them. However, it is not a "magic pill" and should be used in conjunction with traditional methods of quitting—planning, setting a quit date, and quit coaching.

How Well it Works

In research studies, varenicline proved to be more effective than placebo or bupropion. Abstinence rates at the end of treatment were: 18% for placebo, 30% for bupropion and 44% for varenicline. These trials included counseling for all participants.

Side Effects and Contraindications

In research studies, varenicline was well tolerated, with overall discontinuation rates similar to placebo. The most common side effects included nausea, headache, trouble sleeping and abnormal dreams. The most common side effect—nausea—can be significantly reduced if the medication is taken with food and water.

Warnings

The FDA and manufacturer have added warnings that varenicline patients have reported depressed mood, agitation, behavior changes and suicidal ideation; some have committed suicide. The FDA recommends healthcare providers use caution in patients: with significant renal impairment, with pre-existing psychiatric conditions, undergoing dialysis. It is also recommended to monitor all patients using varenicline for psychological symptoms. If you experience any new or different psychological symptoms, please stop the medication and contact your doctor.

The FDA released a new drug safety communication regarding the risk of cardiovascular events while taking varenicline. A higher occurrence of major adverse cardiovascular events (a combined outcome of cardiovascular-related death, nonfatal heart attack, and nonfatal stroke) was observed in patients using Chantix compared to placebo. These events were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant, which means it is uncertain whether the excess risk for the Chantix group was due to the drug or due to chance.

For the most up to date information about varenicline warnings, see: http://www.fda.gov/Drugs/DrugSafety/ucm330367.htm

Dosage and Cost

Start varenicline one week before the quit date for maximum effectiveness. Recommended treatment is 12 weeks:

       ⇒  Days 1-3:                   1 pill (0.5 mg) per day;
       ⇒  Days 4-7:                   1 pill (0.5 mg) twice a day (a.m. and p.m.)
       ⇒  Day 8 to the end:        1 pill (1 mg) twice a day (a.m. and p.m.)

For best results, quit smoking on Day 8

An additional course of 12 weeks for maintenance can be considered. The manufacturer pre-packages Chantix so the pills are laid out day-by-day, in a "Starting Month" package (four weeks) and "Continuing Month" packages thereafter.

Varenicline is covered by many health care plans.

The information presented is intended for general information and educational purposes. It is not intended to replace the advice of your health care provider. Contact your health care provider if you believe you have a health problem.