Varenicline (Champix) Dosing and Patient Advice
Start varenicline 1 week before your quit date using a titration schedule: 0.5 mg once daily for days 1-3, then 0.5 mg twice daily for days 4-7, then 1 mg twice daily for the remaining 11 weeks. 1, 2
Standard Dosing Regimen
The FDA-approved dosing schedule is designed to minimize nausea while achieving therapeutic levels:
- Days 1-3: 0.5 mg once daily (morning) 3, 2
- Days 4-7: 0.5 mg twice daily 3, 2
- Weeks 2-12: 1 mg twice daily (maintenance dose) 3, 1, 2
Set your quit date for 1 week after starting the medication (between days 8-35 of treatment is acceptable if needed). 2
Treatment Duration
Complete the full 12-week course, and if you successfully quit smoking, continue for an additional 12 weeks (total 24 weeks) to significantly increase long-term abstinence rates. 1, 2 This extended treatment approach was validated in a trial of 1,236 smokers and substantially improves the likelihood of remaining smoke-free. 1
Behavioral Support Requirements
You must receive at least 4 counseling sessions during the 12-week treatment period, with the first session within 2-3 weeks of starting medication. 1 Sessions should last 10-30+ minutes, as longer and more frequent counseling is directly linked to higher success rates. 1
Common Side Effects and Management
Nausea is the most common side effect, occurring in 28-40% of patients, typically peaking in weeks 1-2 and diminishing over time. 1, 4, 5 The gradual dose titration schedule specifically addresses this issue. 1 Reassure yourself that nausea typically improves after the first 2 weeks. 1
Other common side effects include:
Take varenicline with food and a full glass of water to minimize nausea. 2
Critical Safety Monitoring
Monitor yourself (and have family/friends monitor you) for neuropsychiatric symptoms including depression, mood changes, agitation, behavioral changes, or suicidal thoughts. 4, 2 While large-scale trials found no significant increase in neuropsychiatric events compared to placebo, postmarketing reports have documented serious cases. 1, 4 Discontinue varenicline immediately and contact your healthcare provider if any of these symptoms occur. 2
Use caution when driving or operating machinery until you know how varenicline affects you. 2
Special Precautions
Reduce alcohol consumption while taking varenicline, as increased effects of alcohol have been reported. 2
If you have a history of seizures, discuss this with your provider, as new or worsening seizures have been observed with varenicline. 2
Follow-Up Schedule
Return for assessment within 2-3 weeks of starting therapy to evaluate smoking status and medication side effects. 1 Additional follow-up should occur at 12 weeks and at the end of therapy. 1
Dose Adjustments
If you have severe kidney disease (creatinine clearance <30 mL/min), your dose should be reduced to 0.5 mg once daily, titrating to 0.5 mg twice daily maximum. 2
If you cannot tolerate side effects, dose reduction may be considered (flexible dosing between 0.5 mg/day and 1 mg twice daily may reduce adverse effects while maintaining efficacy). 1
If Treatment Fails
If you relapse or fail to quit, another treatment attempt is recommended once factors contributing to the failed attempt are identified and addressed. 2 Varenicline remains effective and well-tolerated for re-treatment. 1
Consider switching to a different pharmacotherapy or intensifying behavioral therapy if initial treatment is unsuccessful. 1
Alternative Gradual Quit Approach
If you are unable or unwilling to quit abruptly, you may use a gradual approach: Start varenicline and reduce smoking by 50% within the first 4 weeks, reduce by another 50% in the next 4 weeks, and reach complete abstinence by 12 weeks, then continue treatment for an additional 12 weeks (total 24 weeks). 2
Efficacy Expectations
Varenicline is the most effective single pharmacotherapy for smoking cessation, increasing your odds of quitting by almost 3-fold compared to placebo and superior to bupropion and single forms of nicotine replacement therapy. 1, 6