- SmokeLESS is a prescription medicine to help adults 18 and over stop smoking.
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. Patients should be encouraged to continue to attempt to quit.

- 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 SmokeLEES.
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 he/she 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.
If the patient has side effects that bother him/her or don't go away, he/she should tell the doctor.

- Although the most common adverse event with SmokeLESS was nausea (seen in approximately 30% of subjects), in most cases it was mild or moderate and often transient
- Median duration of nausea was 10 days; however, for some subjects, it was persistent throughout the course of therapy.
- The discontinuation rate due to nausea was approximately 3%.
The overall discontinuation rate due to adverse events in 12-week clinical trials was 12% with varenicline vs 10% with placebo.

- Patient may have trouble sleeping, vivid, unusual, or strange dreams while taking SmokeLESS.
the patient should use caution driving or operating machinery until he/she knows how quitting smoking with SmokeLESS may affect him/her.

- SmokeLESS should not be taken with other quit-smoking products.
The 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 quitting smoking.

- Smoking cessation, with or without treatment with SmokeLESS, may alter the pharmacokinetics or pharmacodynamics of some drugs, such as theophylline, warfarin, and insulin. Dosage adjustment for these drugs may be necessary.