Can varenicline (Chantix) be continued beyond the first month?

From the Guidelines

Yes, you can continue to take Chantix (varenicline) after the first month, and in fact, the standard treatment course is typically 12 weeks (3 months) total. After your first month, you should continue taking the maintenance dose of 1 mg twice daily 1. The first month usually involves a gradual dose increase (starting with 0.5 mg once daily for days 1-3, then 0.5 mg twice daily for days 4-7, and finally 1 mg twice daily from day 8 onward). Continuing the medication for the full recommended course is important because it helps maintain the blockade of nicotine receptors in your brain, reducing cravings and withdrawal symptoms while your brain chemistry adjusts to being nicotine-free. Some key points to consider when taking Chantix include:

• A minimum of 12 weeks of combination NRT or varenicline is recommended for the initial quit attempt 1
• Therapy may be extended to promote continued cessation (ie, 6 months–1 year) while attempting to avoid longer periods of time if possible 1
• Follow-up is recommended (in-person or by phone) within 2 weeks after starting pharmacotherapy, but can be extended to within 3 weeks to coordinate with regularly scheduled oncology appointments, as needed 1
• Nicotine withdrawal symptoms typically peak within 1–2 weeks of quitting and then subside 1 Some people may benefit from an additional 12 weeks of treatment if they've successfully quit smoking but need more support to prevent relapse 1. Always take Chantix as prescribed by your healthcare provider, and discuss any side effects or concerns with them rather than stopping the medication abruptly.

From the FDA Drug Label

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

• Treatment duration: The recommended treatment duration with varenicline is 12 weeks, with an option for an additional 12 weeks for patients who have successfully stopped smoking.
• Continuation after the first month: Patients can continue to take varenicline after the first month, as the standard treatment duration is 12 weeks, and an additional 12 weeks is recommended for patients who have successfully stopped smoking 2.

From the Research

Continuing Chantix After the First Month

• The usual oral dosage of Chantix (varenicline) is 1 mg twice daily for 12 weeks, with an initial titration week 3.
• There is no specific guidance in the provided studies on continuing Chantix after the first month, but the standard treatment duration is 12 weeks 3.
• Varenicline exhibits linear pharmacokinetics following single- and multiple-dose administration of up to 3 mg/day, and steady-state conditions are reached within 4 days of repeat dosing 3.
• The elimination half-life of varenicline is approximately 24 hours, which suggests that the medication can be continued beyond the first month without significant accumulation 3.

Efficacy of Chantix for Smoking Cessation

• Varenicline has been shown to be effective for smoking cessation, with a higher success rate compared to bupropion and nicotine replacement therapy 4, 5, 6.
• The efficacy of varenicline is increased with higher exposure, and the 1 mg twice-daily dose regimen is reliably associated with greater exposure and an increased probability of achieving a stable quit within 1 year from the start of treatment 3.
• Varenicline plus counseling may be the best pharmacological option for the treatment of smoking, especially for individuals with major depressive disorder, given its greater efficacy effect size and similar risk of neuropsychiatric adverse events 5, 6.

Safety of Continuing Chantix

• The risk of neuropsychiatric adverse events does not differ by medication, including varenicline, within the major depressive disorder cohorts 5, 6.
• Varenicline is generally safe, with nausea being the single most frequently reported adverse event, and the incidence is sex-related and increased with varenicline exposure 3.
• There is no evidence to suggest that continuing Chantix after the first month would increase the risk of adverse events 3, 5, 6.