Is Chantix (varenicline) still used for smoking cessation?

Is Chantix (Varenicline) Still Being Used?

Yes, Chantix (varenicline) remains FDA-approved and is actively recommended as a first-line, preferred pharmacotherapy for smoking cessation by major medical societies, with the most recent 2023 guidelines from the American Heart Association/American College of Cardiology identifying it as the most effective single medication option for quitting smoking. 1

Current FDA Status and Indications

Varenicline tablets are FDA-approved and indicated for use as an aid to smoking cessation treatment. 2 The medication has maintained its approval status since 2006, though it has undergone safety evaluations and label updates over the years. 2

Guideline Recommendations and Clinical Use

Preferred Status in Current Guidelines

• The 2023 AHA/ACC guidelines explicitly recommend varenicline as more effective than both bupropion and nicotine replacement therapy (NRT), with pooled data from 5 trials (n=5,877) showing a relative risk versus bupropion of 1.39 (95% CI, 1.25-1.54), and from 8 trials (n=6,264) showing a relative risk versus NRT of 1.25 (95% CI, 1.14-1.37) for achieving abstinence. 1

• The 2016 NCCN guidelines list varenicline as one of two "Preferred Primary Therapy" options (alongside combination NRT) for smoking cessation in cancer patients. 1

• Varenicline increases quit odds almost 3-fold compared to placebo (RR 2.24,95% CI 2.06-2.43). 3, 4

Standard Dosing Regimen Currently Recommended

The current standard approach involves: 1, 3, 4

• Initiate dosing 1-2 weeks prior to the quit date
• Days 1-3: 0.5 mg orally once daily
• Days 4-7: 0.5 mg orally twice daily
• Weeks 2-12: 1 mg orally twice daily (if tolerated)
• Standard treatment duration is 12 weeks, with consideration for an additional 12 weeks in successful quitters to increase long-term abstinence rates

Safety Profile and Monitoring Requirements

Resolved Safety Concerns

The neuropsychiatric safety concerns that generated controversy in the past have been largely addressed by recent high-quality evidence. A large multicenter randomized controlled trial examined neuropsychiatric safety in two cohorts (those with diagnosed psychiatric disorders [n=4,074] and those without [n=3,984]) and found that rates of neuropsychiatric adverse events with varenicline were not significantly increased relative to nicotine patches or placebo in either cohort. 1, 3, 4

The 2023 AHA/ACC guidelines note that while the FDA issued a warning in 2011 for possible increased cardiovascular risk in persons with CVD using varenicline, subsequent meta-analyses through 2016 found no increased cardiovascular risk, and a trial of 8,058 persons found no difference in cardiovascular events among varenicline, bupropion, and NRT groups. 1

Current Monitoring Recommendations

Despite the reassuring safety data, clinicians should still: 1, 3, 2

• Monitor for neuropsychiatric symptoms including depression, agitation, behavioral changes, and suicidal ideation throughout treatment, though large-scale trials show no significant increase compared to placebo
• Manage nausea, which occurs in 28-40% of patients, typically peaks in weeks 1-2, and diminishes over time
• Follow-up within 2-3 weeks after starting pharmacotherapy, with additional periodic follow-up at minimum 12-week intervals

Specific Contraindications and Cautions

• Contraindicated in patients with history of serious hypersensitivity or skin reactions to varenicline 2
• Avoid in patients with brain metastases due to seizure risk 1, 3
• Use cautiously in patients with history of seizures or other factors that lower seizure threshold 2
• Nausea may need careful management in cancer patients, especially during chemotherapy 1, 3

Clinical Implementation Algorithm

For patients seeking smoking cessation pharmacotherapy: 1, 4

1. First-line choice: Varenicline (unless contraindicated), combined with behavioral counseling (4 or more sessions during 12-week treatment)
2. Alternative first-line: Combination NRT (long-acting patch + short-acting form for cravings)
3. Second-line: Bupropion (if varenicline contraindicated or not tolerated, or as add-on to NRT)
4. For treatment failure or relapse: Switch between varenicline and combination NRT before trying subsequent options; intensify behavioral therapy

Common pitfall to avoid: Do not withhold varenicline based on outdated neuropsychiatric concerns—the most recent and highest quality evidence (large RCTs through 2023) demonstrates no significant increase in neuropsychiatric or cardiovascular events compared to placebo or other cessation aids. 1, 3