For the first time since 2021, varenicline—a widely recognized pill designed to help individuals quit smoking—will be available through the National Health Service (NHS) once again. Considered one of the most effective methods for quitting smoking, varenicline is classified as an “essential medicine” by the World Health Organization (WHO).

What is this ‘new’ smoking cessation pill?

Varenicline, a once-daily tablet, was first introduced in 2007. However, it was withdrawn from the market in 2021 after testing revealed higher-than-allowed levels of impurities, known as nitrosamines, in certain batches. Nitrosamines are substances found in foods, drinks, and medications, and while they are naturally occurring, they can pose health risks when consumed in excessive amounts over long periods. Animal studies suggest that high levels of nitrosamines may be linked to cancer. As a result, products containing nitrosamines must adhere to strict limits.

With the new formulation now approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), varenicline will once again be available to the public through the NHS.

How does Varenicline work?

Varenicline is classified as a nicotine receptor partial agonist, which means it interacts with the brain’s nicotine receptors in a specific way. It works by blocking nicotine from attaching to these receptors, thereby reducing the pleasurable effects of smoking. Simultaneously, it activates these receptors to alleviate withdrawal symptoms and reduce cravings. This combination helps make the process of quitting more manageable, and it increases the likelihood of success by reducing the urge to smoke and diminishing the rewarding feelings associated with nicotine.

How effective is it?

The effectiveness of varenicline is impressive. Clinical studies show that about 12 to 16 out of every 100 individuals using varenicline successfully quit smoking, compared to only 6 out of 100 people who try to quit without any aids. This indicates that varenicline can more than double, or even triple, the chances of quitting when compared to unaided efforts.

How does it compare with other smoking cessation treatments?

Varenicline is not the only treatment available for those wishing to stop smoking in the UK. Evidence suggests that nicotine vapes help 10 to 19 people out of 100 quit smoking. Additionally, combining two types of nicotine replacement therapy (e.g., patches and gum) provides similar results. The use of a single nicotine replacement therapy method, such as patches or gum, combined with another medication called bupropion, offers slightly lower success rates, helping around 8 to 9 people out of 100 quit.

Are there any side effects?

Like any medication, varenicline is associated with potential side effects. Common non-serious effects include nausea, sleep disturbances, vivid dreams, and mood changes. There were previously concerns that varenicline might be linked to suicidal thoughts or behavior, but a comprehensive study has since found no evidence supporting this claim.

How many lives might it save?

The reintroduction of varenicline has the potential to significantly impact public health. Smoking remains a leading cause of death, with at least one in every two smokers dying from smoking-related diseases. NHS England estimates that varenicline could assist more than 85,000 individuals in quitting smoking each year, preventing up to 9,500 deaths annually.

The benefits of quitting smoking begin almost immediately. Heart rate decreases to healthier levels within minutes of stopping, and the risk of heart disease is halved within a few years. Over time, overall health continues to improve.

Today, there are a variety of ways to quit smoking—from nicotine vapes to medication-based options—and these aids work best when combined with counseling. Although quitting can be challenging and may require multiple attempts, many individuals ultimately succeed in quitting for good.

Commentary by YourDailyFit columnist Alice Winters

Varenicline’s return to the market after a period of hiatus due to contamination issues highlights both its efficacy and the complex regulatory landscape for health products. As one of the most effective smoking cessation aids, varenicline’s ability to double or even triple the success rate of quitting in comparison to unaided attempts is an impressive feat. Its mechanism of action—blocking nicotine receptors while simultaneously alleviating withdrawal symptoms—provides a dual benefit that enhances the chances of a successful quit attempt.

The reapproval of varenicline by the MHRA underscores the rigorous testing processes that exist to ensure the safety and effectiveness of medications, especially when issues like nitrosamine contamination arise. While the presence of nitrosamines in the previous batches raised valid concerns, the new formulation is carefully vetted to meet the strictest standards. This move will undoubtedly benefit many individuals seeking assistance in quitting smoking, a challenge that remains one of the most difficult public health issues globally.

However, varenicline’s effectiveness is only one piece of the puzzle in the fight against smoking. Although the pill increases quit rates significantly, the support system surrounding its use—including counseling and behavioral therapy—plays a crucial role in ensuring long-term success. This collaborative approach can greatly enhance the impact of varenicline in helping people break free from nicotine addiction.

In terms of competition, other smoking cessation methods such as nicotine vapes and replacement therapies also play significant roles. The fact that vapes have shown comparable effectiveness, albeit with a different approach, means that smokers have various options at their disposal. Nicotine replacement therapy, when combined with other methods like bupropion, also shows promising results, though slightly less effective than varenicline alone.

While side effects such as nausea and mood swings are not uncommon, the reassurance from large-scale studies discrediting concerns about suicidal thoughts provides a sense of security for potential users. That being said, continued monitoring and transparent communication about side effects remain essential for maintaining trust in the product.

From a broader perspective, varenicline’s reintroduction could have a profound public health impact. Smoking remains one of the leading causes of preventable death worldwide, and providing a reliable tool to quit is invaluable. With proper use and support, varenicline offers a crucial resource in the ongoing battle against smoking-related diseases. Ultimately, the drug’s availability could save thousands of lives each year, reducing both the human and economic costs of smoking.

This article serves as a reminder that despite the presence of several alternatives, there is no “one-size-fits-all” solution. Quitting smoking requires a multi-faceted approach, and varenicline’s combination of medical and behavioral support is a potent tool in achieving that goal.