Varenicline (Chantix) Availability Status
Yes, varenicline is currently available for smoking cessation. The FDA-approved drug label confirms varenicline tablets are indicated for use as an aid to smoking cessation treatment, with current prescribing information available as of 2025 1.
Current Status and Background
Varenicline was initially approved by the FDA in 2006 and remains an active prescription medication 2. The drug is marketed as both Chantix (in the United States) and Champix (in Europe) 3, 2.
Note: While varenicline experienced a temporary recall in 2021 due to nitrosamine impurity concerns, the medication has since returned to the market with resolved manufacturing issues. The 2025 FDA label confirms its current availability 1.
Clinical Positioning
Varenicline is recommended as a preferred first-line pharmacotherapy for smoking cessation:
The National Comprehensive Cancer Network (NCCN) guidelines list varenicline as one of two preferred primary therapy options (alongside combination nicotine replacement therapy) for initial smoking cessation attempts 4.
Varenicline increases smoking cessation odds by almost 3-fold compared to placebo and demonstrates superior efficacy to bupropion and single forms of nicotine replacement therapy 5, 6.
The European Society of Cardiology guidelines support varenicline use, noting it increases chances of successful long-term smoking cessation between two- to three-fold compared with unassisted quit attempts 4.
Standard Prescribing Regimen
The FDA-approved dosing schedule is 1:
- Week before quit date: Begin dosing 1-2 weeks prior to target quit date
- Days 1-3: 0.5 mg once daily
- Days 4-7: 0.5 mg twice daily
- Weeks 2-12: 1 mg twice daily (maintenance dose)
- Extended therapy: An additional 12-week course is recommended for successful quitters to increase likelihood of long-term abstinence 1, 5
Important Safety Considerations
Neuropsychiatric monitoring is required: The FDA mandates observation for serious neuropsychiatric adverse events including depression, suicidal ideation/behavior, mood changes, psychosis, and aggression 1. Patients should discontinue varenicline and contact their healthcare provider if such symptoms occur 1.
Common manageable side effects include:
- Nausea (occurs in 30-40% of users, typically mild to moderate and diminishes over time) 5
- This may require careful management in cancer patients undergoing chemotherapy 4, 5
Contraindications and precautions:
- Contraindicated in patients with brain metastases due to seizure risk 4
- Use cautiously in patients with history of seizures 1
- Dose adjustment required for severe renal impairment (creatinine clearance <30 mL/min): 0.5 mg once daily titrated to 0.5 mg twice daily 1
Behavioral Support Requirements
Varenicline must be combined with behavioral counseling for optimal outcomes 5: