What is SmokeLESS?

SmokeLESS (varenicline) is a prescription medicine to help adults 18 and over stop smoking.
SmokeLESS helps reduce the urge to smoke.

How is SmokeLESS different from other smoking cessation products?

SmokeLESS is a non-nicotine pill.
SmokeLESS targets nicotine receptors in the brain, attaches to them, and blocks nicotine from reaching them.

Is Smokeless effective?

- In studies, 44% of varenicline (SmokeLESS) users were quit during weeks 9 to 12 of treatment (compared to 18% on sugar pill).
Varenicline also helped reduce the urge to smoke.
- Varenicline has been proven to be more effective in helping smokers quit than bupropion hydrochloride.


What should the doctor know before prescribing SmokeLESS?

The doctor should know about all the patient’s medical conditions including if the patient:

- has ever had depression or other mental health problems, as these symptoms may worsen while taking SmokeLESS.

- experienced nicotine withdrawal symptoms with prior quit attempts, with or without SmokeLESS.
Quitting smoking, with or without SmokeLESS, can result in nicotine withdrawal symptoms (such as depressed mood, agitation) or a worsening of existing mental health problems, such as depression.

- has kidney problems or gets kidney dialysis.
the doctor may prescribe a lower dose of SmokeLESS for him/her.

- is pregnant or plan to become pregnant.
SmokeLESS has not been studied in pregnant women. It is not known if SmokeLESS will harm the patient’s unborn baby.
It is best for the patient to stop smoking before she gets pregnant.

- is breastfeeding. Although it was not studied, SmokeLESS may pass into breast milk.
The patient and the doctor should discuss alternative ways to feed the baby if the patient takes SmokeLESS.

The doctor should know about all patient’s other medicines including prescription and nonprescription medicines, vitamins, and herbal supplements.

Especially, he should know if the patient takes:

- Insulin
- Asthma medicines
- Blood thinners

When the patient stops smoking, there may be a change in how these and other medicines work for him/her.

Patients should not use SmokeLESS while using other treatments to quit smoking.

They should tell the doctor if they use other treatments to quit smoking.

How should the patient take SmokeLESS?

1. Patients should choose a Quit Date when they will stop smoking.
2. Start taking SmokeLESS one week (7 days) before their Quit Date.
This lets SmokeLESS build up in the patient’s body.
Patients can keep smoking during this time.
Make sure that patients try and stop smoking on their Quit Date.
If they slip up, they should try again. Some people need a few weeks for SmokeLESS to work best.
3. Patients should take SmokeLESS after eating and with a full glass (8 ounces) of water.
4. It is recommended that patients take SmokeLESS for a full 12 weeks.
If they have completely quit smoking by 12 weeks, they should ask the doctor if another 12 weeks of SmokeLESS may help them stay cigarette-free.

SmokeLESS comes as a white tablet (0.5 mg) and a blue tablet (1 mg).
Patients should start with the white tablet and then usually go to the blue tablet.
The chart below explains dosing instructions.

- This dosing schedule may not be right for everyone. Patients may need a lower dose of SmokeLESS if they have kidney problems or get dialysis.
- When patients miss a dose, they should take it as soon as they remember. If it is close to the time for the next dose, they should wait, and just take the next regular dose.

What should the healthcare professional do to push patients towards quitting?

Since counseling plus pharmacotherapy with SmokeLESS is more effective than medical intervention alone, the healthcare professional role is very important in the quitting process...

Here are a few steps that may help the healthcare professional to push patients towards quitting.

- Ask every patient. More than 90% of all smokers, regardless of their stage of readiness, feel that physicians should ask smokers to quit. Even brief counseling has proven to be effective.
- Use the 5 A’s and the the 5 R’s to support your patient plan to quit.
- Put smokers on the SmokeLESS path.
- Provide counseling.
- Follow up.

What are the possible side effects and safety information of SmokeLESS?

Some patients have reported changes in behavior, agitation, depressed mood, suicidal thoughts or actions when attempting to quit smoking while taking SmokeLESS or after stopping SmokeLESS.

If either the patient, his/her family, or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for the patient, or if the patient develops suicidal thoughts or actions, he/she should stop taking SmokeLESS and call the doctor right away.

Also the patient should tell the doctor about any history of depression or other mental health problems before taking SmokeLESS, as these symptoms may worsen while taking SmokeLESS.

The most common side effects of SmokeLESS include:

- Nausea (30%) • Sleep problems (trouble sleeping, changes in dreaming)
- Constipation
- Gas
- Vomiting

Patients should tell the doctor about side effects that bother them or that do not go away.

Patients should use caution driving or operating machinery until they know how quitting smoking and/or using SmokeLESS may affect them.


What are the important safety information about SmokeLESS?

SmokeLESS is a prescription medicine to help adults 18 and over stop smoking.
Some patients have reported changes in behavior, agitation, depressed mood, suicidal thoughts or actions when attempting to quit smoking while taking SmokeLESS or after stopping SmokeLESS.
If either the patient, his/her family, or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for the patient, or if the patient develops suicidal thoughts or actions, he/she should stop taking SmokeLESS and call the doctor right away.

Also the patient should tell the doctor about any history of depression or other mental health problems before taking SmokeLESS, as these symptoms may worsen while taking SmokeLESS.
The most common side effects include nausea (30%), sleep problems, constipation, gas, and/or vomiting.
Patients should tell the doctor about side effects that bother them or that do not go away.
Patients may have trouble sleeping, vivid, unusual, and/or strange dreams while taking SmokeLESS.
Patients should use caution driving or operating machinery until they know how quitting smoking with SmokeLESS may affect them.

SmokeLESS should not be taken with other quit-smoking products.
Patient may need a lower dose of SmokeLESS if he/she has kidney problems or gets dialysis.
Before starting SmokeLESS, the patient should tell the doctor if she is pregnant, plans to become pregnant, or if he/she takes insulin, asthma medicines or blood thinners. Medicines like these may work differently when patients quit smoking.


How long should the patient take SmokeLESS?

It is recommended SmokeLESS be taken for a full 12 weeks or as prescribed by the doctor.
If the patient has completely quit smoking by 12 weeks, he/she should ask the doctor if another 12 weeks of SmokeLESS may help him/her stay cigarette free.


What should patients do if they miss a dose of SmokeLESS?

If patients miss a dose, they should take it as soon as they remember.
If it is close to the time for the next dose, they should wait. Just take the next regular dose.


What if patients slip up while taking SmokeLESS?

Doctors should always keep in their mind that patients may choose to smoke for the first week they are on SmokeLESS.
Try to make them stop smoking completely on their Quit Date (Day 8).
But if they slip up, the most important thing is that they should not give up! Some people need a few weeks for SmokeLESS to work best.
In studies, 44% of SmokeLESS users were quit during weeks 9 to 12 of treatment (compared to 18% on sugar pill).
Some people who smoked after their Quit Date were able to quit successfully.


Will patients urge to smoke go away when they take SmokeLESS?

Patients might still feel some urge to smoke. But it might be less than they’d have without SmokeLESS.
Doctors should remember that it's possible that patients might slip up and smoke while taking SmokeLESS.
If they do, they can stay on SmokeLESS and keep trying to quit.


Who should not take SmokeLESS?

SmokeLESS has not been studied in children under 18 years of age.
SmokeLESS is not recommended for children under 18 years of age.
SmokeLESS should not be taken by patients who are allergic to anything in it.
Patients should not use SmokeLESS while using other treatments to quit smoking. They should tell the doctor if they use other treatments to quit smoking.


How should patients store SmokeLESS?

SmokeLESS should be stored at room temperature, 59 to 86°F (15 to 30°C)