From the Guidelines
Chantix (varenicline) should be taken according to a gradual dosing schedule, starting with 0.5 mg once daily for the first three days, then increasing to 0.5 mg twice daily for days 4-7, and finally reaching the maintenance dose of 1 mg twice daily from day 8 through the end of treatment, usually 12 weeks total, as this regimen has been shown to be effective in reducing withdrawal symptoms and blocking the pleasurable effects of smoking, as supported by the most recent and highest quality study 1.
Key Points to Consider
- The dosing schedule is designed to minimize side effects while building effective levels in the body.
- Patients should set a quit date, usually during the second week of treatment, allowing the medication to reach effective levels before completely stopping smoking.
- Chantix should be taken after eating with a full glass of water to reduce nausea, which is a common side effect.
- If the 12-week treatment is successful, an additional 12 weeks may be prescribed to increase long-term abstinence rates.
Important Considerations
- Varenicline has been shown to be more effective than bupropion or NRT in achieving abstinence from cigarette smoking in meta-analyses of randomized trials, with a pooled estimate from 5 trials showing a relative risk versus bupropion of 1.39 (95% CI, 1.25-1.54), and a pooled estimate of 8 trials showing a relative risk versus NRT of 1.25 (95% CI, 1.14-1.37) for abstinence favoring varenicline, as reported in the 2023 AHA/ACC/ACCPC/ASPC/NLA/PCNA guideline 1.
- The effectiveness of varenicline is highest when used in combination with behavioral therapy, which can include group and individual in-person counseling, telephone-based support, interactive internet-based interventions, and text message–based interventions.
- Clinicians should provide clear, personalized, nonjudgmental advice to quit tobacco smoking, focusing on the benefits of smoking cessation, such as improved heart health, as stated in the 2023 AHA/ACC/ACCPC/ASPC/NLA/PCNA guideline 1.
From the FDA Drug Label
2 DOSAGE AND ADMINISTRATION
2.1 Usual Dosage for Adults Smoking cessation therapies are more likely to succeed for patients who are motivated to stop smoking and who are provided additional advice and support. Provide patients with appropriate educational materials and counseling to support the quit attempt. The patient should set a date to stop smoking. Begin varenicline tablets dosing one week before this date Alternatively, the patient can begin varenicline tablets dosing and then quit smoking between days 8 and 35 of treatment. Varenicline tablets should be taken orally after eating and with a full glass of water. The recommended dose of varenicline tablets is 1 mg twice daily following a 1-week titration as follows: Days 1 to 3: 0.5 mg once daily Days 4 to 7: 0.5 mg twice daily Day 8 to end of treatment: 1 mg twice daily Patients should be treated with varenicline tablets for 12 weeks. For patients who have successfully stopped smoking at the end of 12 weeks, an additional course of 12 weeks treatment with varenicline tablets is recommended to further increase the likelihood of long-term abstinence
Varenicline (Chantix) Dosage for Smoking Cessation:
- The patient should set a date to stop smoking and begin varenicline tablets dosing one week before this date.
- The recommended dose is 1 mg twice daily following a 1-week titration.
- Patients should be treated for 12 weeks, with an additional 12 weeks of treatment recommended for those who have successfully stopped smoking.
- Varenicline tablets should be taken orally after eating and with a full glass of water.
- A gradual approach to quitting smoking can be considered for patients who are not able or willing to quit abruptly 2. Key Points:
- Start dosing one week before the quit date or begin dosing and quit between days 8 and 35.
- Titrate dosage over the first week.
- Treat for 12 weeks, with an option for an additional 12 weeks.
- Take tablets orally after eating with a full glass of water.
From the Research
Dosage and Administration
- Varenicline is taken orally, with a recommended dose of 1 mg twice daily 3, 4, 5, 6.
- The treatment should begin 7 days before the proposed smoking quit date, with dose titration recommended to minimize dose-related nausea 6.
- Varenicline is almost entirely absorbed following oral administration, and absorption is unaffected by food, smoking, or the time of day 3.
Efficacy
- Varenicline has been shown to be effective in aiding smoking cessation, with significantly higher abstinence rates compared to placebo and bupropion sustained-release 3, 4, 5, 6.
- The continuous quit rates for any 4 weeks were significantly higher for varenicline 1 mg twice daily (48.0%) and 1 mg once daily (37.3%) than for placebo (17.1%) 5.
- Varenicline was also associated with significantly higher rates of abstinence than placebo treatment in randomized, double-blind, clinical trials in smokers in several countries 3.
Safety and Tolerability
- Varenicline was generally well tolerated in study populations with no major comorbidities 6.
- The most commonly reported adverse events with varenicline were nausea (28.8%), insomnia (14.2%), and headache (14.2%) 6.
- Varenicline treatment was associated with lower urge to smoke and satisfaction from smoking in relapsers than placebo or active comparators 3, 4.