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Nicotine Addiction: Treatment & Medication
Updated: Oct 14, 2009
- Overview
- Differential Diagnoses & Workup
- Treatment & Medication
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Treatment
Medical Care
Smoking Cessation Guidelines
Smoking may begin as a voluntary habit, but eventually it becomes an addiction. Health professionals can contribute powerfully to motivate their patients to attempt and sustain cessation by offering encouragement, advice, and assistance. For patients who are not yet ready to attempt quitting, such advice can move them further toward that point. A willingness to help and to provide assistance is very important in motivating cigarette smokers in attempting to quit. The reassurance that a knowledgeable health professional stands ready to offer guidance and support is immensely beneficial to individuals addicted to nicotine.According to the US Preventive Services Task Force (USPSTF) guidelines, clinicians should ask all adults about use of tobacco products and provide cessation interventions to current users. The guideline engages a “5-A” approach to counseling that includes the following:6
- Ask about tobacco use.
- Advise to quit through personalized messages.
- Assess willingness to quit.
- Assist with quitting.
- Arrange follow-up care and support.
Brief behavioral counseling (ie, under 10 min) and pharmacotherapy are each effective alone—although they are most effective when used together.7
The task force also advises clinicians to ask all pregnant women, regardless of age, about tobacco use. Those who currently smoke should receive pregnancy-tailored counseling supplemented with self-help materials.
Understanding the benefits and limitations of the available medications provides an important foundation for such a successful smoking cessation program.
- Assess smoking history, level of addiction, and the health status of the patient (see Media file 1). After the assessment, intervene with education and advice.
Smoking cessation strategies for clinicians.
- Educate patients about the benefits of smoking cessation and the cessation process. Provide a description of the expected withdrawal syndrome. Continue with a discussion of the possible cessation methods, which include counseling, nicotine replacement, antidepressant medications, behavioral training, group therapy, hypnosis, and quitting "cold turkey."
- More than 90% of patients who attempt to quit smoking stop cold turkey.
- Professional group therapy or counseling achieves a 60-100% initial cessation rate and a 1-year cessation rate of approximately 20%.
- Hypnosis and acupuncture are popular programs that might encourage renewed attempts by people who failed other techniques, but they are no different from placebo.
- Verify successful cessation by measuring cotinine or carbon monoxide levels.
- A cigarette delivers 1.2-2.9 mg of nicotine, and the typical one pack-per-day smoker absorbs 20-40 mg of nicotine each day, raising the plasma concentrations to between 23-35 ng/mL. Nicotine produces increased expression of brain nicotine receptors, changes in regional brain glucose metabolism, the release of catecholamines, tolerance, and physiologic dependence. Nicotine addiction results from positive reinforcement (with the administration of nicotine) and withdrawal symptoms that start within a few hours of the last cigarette. The time to first cigarette and total cigarettes per day are the two strongest predictors of nicotine addiction. The nicotine dependence and nicotine withdrawal could be treated by the following:8,9
- Other forms of nicotine delivery
- Drugs that selectively target one or more of the underlying mechanisms
- Behavioral treatments, acupuncture, and other therapies
Smoking Cessation Therapies and Medications
Nicotine replacement therapy10
Nicotine replacement therapy works by making it easier to abstain from tobacco by partially replacing the nicotine previously obtained from tobacco. At least 3 mechanisms by which NRT could be effective include (1) reducing either general withdrawal symptoms, thus allowing people to learn without cigarettes, (2) reducing the reinforcing effects of tobacco-delivered nicotine, and (3) providing some psychological effects on mood and attention states.
Nicotine replacement medications should not be viewed as stand-alone medications that make people stop smoking. Reassurance and guidance from health professionals can be critical to achieve and sustain abstinence. Six types of nicotine replacement products are on the market. These include nicotine transdermal patch systems; nicotine nasal spray; and nicotine delivery through the oral mucosa including gum, lozenge, sublingual tablet, and vapor inhaler. Common adverse events that are common to all NRT products include dizziness, nausea, and headache.
- Transdermal nicotine patches11
- Nicotine patches deliver nicotine through the skin at a relatively steady rate. Currently, 4 patch formulations are on the market; they vary widely in their design, pharmacokinetics, and duration of wear (ie, 24- and 16-h wear). For some products, progressively lower doses can be used to provide weaning over a period of several weeks or longer to enable gradual adjustment to lower nicotine levels and ultimately to a nicotine-free state. Smokers who use more than 10 cigarettes per day should use the 21-mg/d patch for the first 6 weeks, move to the 14-mg/d strength for 2 weeks, then use the 7-mg dose for the final 2 weeks. Nicotine patches have higher compliance than other NRT products but may not adequately protect against craving provoked by smoking-related stimuli. For breakthrough cravings not adequately controlled by transdermal nicotine alone, acute therapies may be added.
- A study tested the efficacy of nicotine patches in combination with behavioral therapy for the treatment of adolescent spit tobacco addiction. The usual care group's spit tobacco cessation rate was 11.4%; placebo patch, 25.0%; and active patch, 17.3%. The cessation rates for active and placebo patch were not significantly different, proving that behavioral intervention is twice as successful and that nicotine patch did not offer additional improvement.12
- Acute dosing forms
- The amount and timing of these products can be titrated by the user, thus allowing the use of NRT medications as rescue medication for cravings. Ongoing craving in a quitter is associated with acute episodes of more intense craving called breakthrough craving. Provoked by situational stimuli, such as seeing someone smoke, or experiencing emotional upset, are associated with very high risk of relapse.
- These therapies may also be used when a situation is expected to produce a craving, such as a demanding meeting, rush-hour traffic, commute, or social situation with cigarette smokers.
- Nicotine gum13
- First available in the 1980s, nicotine polacrilex (nicotine gum) is available without a prescription. The gum is available in doses: 2 mg and 4 mg, delivering approximately 1 mg and 2 mg of nicotine. Users are instructed to use a piece of gum every 1-2 hours for the first 6 weeks, then to reduce use to one piece every 2-4 hours for 3 weeks, and one piece every 4-8 hours for 3 weeks. In highly dependent smokers, the 4-mg gum is superior to the 2-mg gum. Since about 50% of the nicotine in gum is absorbed, a fixed schedule of 10 pieces per day, a smoker receives about 10 mg or 20 mg of nicotine per day using the 2-mg or 4-mg gum, respectively.
- The slow absorption of nicotine from gum doses does not produce the extremely high levels of nicotine. Acidic beverages interfere with buccal absorption of nicotine; patients should avoid acidic beverages (eg, soda, coffee, beer) for 15 minutes before and during chewing gum. Nicotine gum chewing may cause jaw soreness; therefore, the smoker should chew the gum to release nicotine, then move the gum between the cheek and gum for a minute or so. Gum can also cause a mild burning sensation in the mouth and throat, which may be undesirable.
- In an open, randomized trial of 314 daily smokers, Etter et al found that starting nicotine gum 4 weeks prior to the quit date did not improve smoking cessation rates compared with initiating gum on the quit date. At follow-up 8 weeks after the target quit date, self-reported 4-week abstinence rates were 41.6% for the pre-quit date treatment group compared with 44.4% in the usual care group. Biochemically verified cessation occurred at 1 year following the quit date for participants, and no difference was found between the 2 groups (20.8% for the pre-quit date group vs 19.4% for the usual care group).14,15
- Lozenge: Available in 2- and 4-mg formulations since 2002, nicotine from the lozenge is absorbed slowly through the buccal mucosa. The lozenge should not be chewed, and the amount of nicotine absorbed per lozenge is somewhat higher than that delivered by gum.
- Inhaler
- Currently marketed as a prescription medication in the United States, the inhaler consists of a mouthpiece and a plastic cartridge containing nicotine. When the inhaler is "puffed," nicotine is drawn into the mouth of the smoker and satisfies the behavioral aspects of smoking, namely, the hand-to-mouth ritual.
- Each inhaler cartridge contains 10 mg nicotine, of which 4 mg can be delivered and 2 mg are absorbed. Nicotine is not delivered to the bronchi or lungs, but rather it is deposited and absorbed in the mouth, like nicotine gum. Most people use between 6 and 16 cartridges a day, the recommended duration of treatment is 3 months, after which patients may be weaned by gradual reduction over the following 6-12 weeks.
- Nasal spray: Marketed as a prescription medication, the nasal spray delivers nicotine more rapidly than other NRTs and delivers acute craving relief. The multidose bottle with a pump delivers 0.5 mg of nicotine per 50-µL squirt. Each dose consists of 2 squirts, one to each nostril. The dose of nasal spray should be individualized for each patient based on the patient's level of nicotine dependence. Most patients are started with 1 or 2 doses per hour, which may be increased up to the maximum of 40 doses per day.
- Sublingual tablet: A small nicotine tablet has been developed but is not yet available in the United States. The product is designed to be held under the tongue, where the nicotine in the tablet is absorbed sublingually. The levels of nicotine obtained by use of the 2-mg tablet and 2-mg nicotine gum are similar. It is recommended that smokers use the product for at least 12 weeks, after that the number of tablets used is gradually tapered.
Smoking cessation treatments with NRT enable smokers to cease tobacco use and subsequently to withdraw from nicotine altogether. However, for some smokers, withdrawing from smoking completely may be difficult. In those individuals, there may be benefit by continuing to use NRT for longer periods, even indefinitely, to prevent relapse to smoking. This strategy is currently used in methadone maintenance programs for heroin-dependent patients, where patients may be maintained on daily doses of methadone for years. Although nicotine is not entirely without risk, nicotine maintenance is clearly safer than cigarette smoke-delivered nicotine with its numerous toxins. Therefore, indefinite NRT to prevent resumption of smoking may be considered for some individuals.
A Cochrane meta-analysis of 132 trials where any type of NRT and a placebo or non-NRT control group showed risk ratio of abstinence for any form of NRT relative to control at 1.58 (95% confidence interval [CI], 1.50-1.66). The pooled RR for each type were 1.43 (95% CI: 1.33 to 1.53, 53 trials) for nicotine gum; 1.66 (95% CI, 1.53-1.81, 41 trials) for nicotine patch; 1.90 (95% CI, 1.36-2.67, 4 trials) for nicotine inhaler; 2.00 (95% CI, 1.63-2.45, 6 trials) for oral tablets/lozenges; and 2.02 (95% CI, 1.49-3.73, 4 trials) for nicotine nasal spray. Therefore, all of the commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler, and sublingual tablets/lozenges) increase the chances of successful smoking cessation. Overall NRTs increase the rate of quitting by 50-70% and appear to be independent of the additional support.
Medications
- Bupropion (Zyban)16,17
- Bupropion acts by alleviating some of the symptoms of nicotine withdrawal, which includes depression. One clinical trial demonstrated that highly nicotine-dependent smokers who receive bupropion are more likely to experience a decrease in depressive symptoms during active treatment. Like NRT products, bupropion has been endorsed by the US Clinical Practice Guideline as a first-line therapy.8
- Bupropion has been shown to approximately double rates of cessation compared with placebo, and the medication is equally effective for men and women. It has also been shown that bupropion combined with nicotine replacement medications may increase cessation rates relative to bupropion alone. The recommended and maximum dose of bupropion is 300 mg/d, given as 150 mg bid. Dry mouth and insomnia are the most common adverse events associated with use. A very small risk of seizure exists, which can be reduced by not prescribing the medication to persons with a history of seizure or a predisposition toward seizure.
- Varenicline (Chantix)
- Varenicline (Chantix) is a partial agonist selective for alpha-4, beta-2 nicotinic acetylcholine receptors. Action is thought to result from activity at a nicotinic receptor subtype, where its binding produces agonist activity while simultaneously preventing nicotine binding. Agonistic activity is significantly lower than nicotine.
- Varenicline, developed as a nicotine receptor partial agonist, help smokers quit by preventing withdrawal symptoms as moderate levels of dopamine are maintained in the brain. Cochrane meta-analysis included 5 trials of varenicline compared with placebo and 3 of these also included a bupropion as comparator. The pooled odds ratio (OR) for continuous abstinence for varenicline versus placebo at 12 months was 3.22, (95% CI, 2.43-4.27). The pooled OR for varenicline versus bupropion was 1.66 (95% CI, 1.28-2.16). The main adverse effect of varenicline was nausea, which was mostly at mild to moderate levels and usually subsided over time. Varenicline increased long-term smoking cessation rates by 3-fold compared with unassisted quit attempts.18
- Other medications: Besides NRT products and bupropion, nortriptyline and clonidine are endorsed by the US Clinical Practice Guideline as second-line therapies.
- Nortriptyline16 : As a second-line therapy, studies have demonstrated the potential efficacy of nortriptyline for smoking cessation in smokers without history of major depression. Nortriptyline in combination with transdermal nicotine was also shown to enhance the cessation rates above levels seen with transdermal nicotine alone. The tricyclic antidepressant doxepin has also been shown in a small human study to improve cessation rates. The most commonly encountered side effects associated with nortriptyline include fast heart rate, blurred vision, urinary retention, dry mouth, constipation, weight gain or loss, and low blood pressure on standing.
- Clonidine: An alpha-2-noradrenergic agonist used to treat hypertension, clonidine has been shown to diminish symptoms of both opiate and alcohol withdrawal symptoms. In one study of heavy smokers who had failed in previous quit attempts found that those treated with clonidine had twice the rate of abstinence as those treated with placebo at the end of the 4-week treatment, and the effect persisted for the 6-month follow-up period. Although clonidine may be efficacious in the treatment of nicotine addiction, the conditions under which it is most appropriately used are not well defined. The most common side effects of clonidine are constipation, dizziness, drowsiness, dryness of mouth, and unusual tiredness or weakness.
Combination products
- To improve smoking cessation, medications can be combined, such as passive nicotine delivery (eg, transdermal patch) with another medication that permits acute nicotine delivery (eg, gum, nasal spray, inhaler). Combining the nicotine patch (which may prevent the appearance of severe withdrawal) with acute dosing forms (which can provide relief in trigger-to-smoke contexts) may provide an excellent treatment option over either therapy alone.19,20
- Bupropion in combination with a nicotine patch appears to be more efficacious than a nicotine patch alone, possibly because the 2 medications act via different pharmacologic mechanisms. Despite the possibility of increased efficacy concluded in the Clinical Practice Guideline, these therapies should be prescribed under the direction of an experienced clinician or the specialty clinic.21
Novel therapies
Since success of most pharmacological and behavior therapies is rather limited, alternative and improved treatments are needed. One novel approach is provided by immunization against nicotine. Antibodies induced by the vaccine bind nicotine in the blood, thus preventing it from reaching the nicotine receptors in the brain and breaking the cycle of nicotine addiction. A prototype vaccine against nicotine has been developed and studied in a randomized trial where 229 subjects received 5 intramuscular injections of the nicotine vaccine and 112 placebo. The vaccine was safe and generally well tolerated, despite failure to significantly increase continuous abstinence rates; results were significant in subgroup analyses. Although more studies are needed, immunotherapy appears to have opened a new avenue to the treatment of nicotine addiction.22
Mecamylamine is a nicotine antagonist that, in principle at least, would seem to have a role in smoking cessation. As much as opiate antagonists prevent the user from achieving a high, so would mecamylamine block any pleasurable affects from nicotine. The research supporting the clinical use of mecamylamine awaits further study.23
Consultations
Patients may be referred for group therapy or behavioral counseling. If an affective disorder is suspected, evaluation by a psychiatrist may be indicated.
Diet
Patients who quit smoking tend to gain weight; therefore, encourage patients to follow a low-calorie diet and exercise regimen during and after cessation.
Activity
While attempting smoking cessation, exercise has been shown to help curb weight gain and to help alleviate nicotine withdrawal symptoms.
Medication
Two types of medications are available as part of a smoking cessation program. Types include nicotine replacement therapy in the form of cutaneous patches, inhaled or nasal delivery, or chewing gum and the non–nicotine-containing tablet bupropion. These medications ameliorate withdrawal symptoms while the smoker deals with behavioral aspects of smoking cessation.
Nicotine chewing gum, if chewed correctly, increases quit rates up to 2-fold. At 1 year, the abstinence rate with the patch is 20%. At 4 years, the abstinence rate is 12.4% compared to 4.5% with placebo.
Nicotine replacement therapy (patches)
Nicotine patches are sold under the following trade names: NicoDerm, Nicotrol, and Habitrol. The dosing schedule of each is a graduated decrease of drug over 9-12 wk.
Nicotine transdermal system (NicoDerm CQ)
Works best when used in conjunction with a support program such as counseling, group therapy, or behavioral therapy.
Adult
One 21-mg patch qd for 6 wk, then one 14-mg patch qd for 2 wk, followed by one 7-mg patch qd for 2 wk
Pediatric
Not established
May decrease diuretic effects of furosemide and decrease cardiac output; may decrease absorption of glutethimide; may increase circulating cortisol and catecholamines; do not use if patient continues to smoke, use snuff, chew tobacco, or use other nicotine products because may increase toxicity of nicotine
Documented hypersensitivity; nonsmokers, children, pregnancy, life-threatening arrhythmias, severe or worsening angina pectoris
Pregnancy
X - Contraindicated; benefit does not outweigh risk
Precautions
Caution in peptic ulcer, coronary artery disease, angina, hypertension, peripheral arterial disease, diabetes, severe renal dysfunction, and hepatic dysfunction; may cause skin irritation
Nicotine transdermal system (Nicotrol)
Works best when used in conjunction with a support program such as counseling, group therapy, or behavioral therapy.
Adult
One 15-mg patch qd for 6 wk, then one 10-mg patch qd for 2 wk, followed by one 5-mg patch qd for 2 wk
Pediatric
Not established
May decrease diuretic effects of furosemide and decrease cardiac output; may decrease absorption of glutethimide; may increase circulating cortisol and catecholamines; do not use if patient continues to smoke, use snuff, chew tobacco, or use other nicotine products because may increase toxicity of nicotine
Documented hypersensitivity; nonsmokers, children, pregnancy, life-threatening arrhythmias, severe or worsening angina pectoris
Pregnancy
X - Contraindicated; benefit does not outweigh risk
Precautions
Caution in peptic ulcer, coronary artery disease, angina, hypertension, peripheral arterial disease, diabetes, severe renal dysfunction, and hepatic dysfunction; may cause skin irritation
Nicotine transdermal system (Habitrol)
Works best when used in conjunction with a support program such as counseling, group therapy, or behavioral therapy.
Adult
One 21-mg patch qd for 3-4 wk, then one 14-mg patch qd for 3-4 wk, followed by one 7-mg patch qd for 3-4 wk
Pediatric
Not established
May decrease diuretic effects of furosemide and decrease cardiac output; may decrease absorption of glutethimide; may increase circulating cortisol and catecholamines; do not use if patient continues to smoke, use snuff, chew tobacco, or use other nicotine products because may increase toxicity of nicotine
Documented hypersensitivity; nonsmokers, children, pregnancy, life-threatening arrhythmias, severe or worsening angina pectoris
Pregnancy
D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus
Precautions
Caution in peptic ulcer, coronary artery disease, angina, hypertension, peripheral arterial disease, diabetes, severe renal dysfunction, and hepatic dysfunction; may cause skin irritation
Nicotine replacement therapy (chewing pieces)
These are marketed in 2 strengths (2 mg and 4 mg). An individual who smokes 1 pack per day should use 4-mg pieces. The 2-mg pieces are to be used by individuals who smoke less than 1 pack per day. Instruct the patient to chew hourly and for their initial cravings for 2 wk, then gradually reduce amount chewed over the next 3 mo.
Nicotine polacrilex (Nicorette)
Comes in boxes containing 96 pieces and costs approximately US $20-30. The nicotine is absorbed through the oral mucosa. Quickly absorbed and closely approximates time course of plasma nicotine levels observed after cigarette smoking.
Adult
1 piece of gum (2 mg) per h as needed to abstain from smoking; not to exceed 30 mg/d
Pediatric
Not established
May decrease diuretic effects of furosemide and decrease cardiac output; may decrease absorption of glutethimide; may increase circulating cortisol and catecholamines; do not use if patient continues to smoke, use snuff, chew tobacco, or use other nicotine products because may increase toxicity of nicotine
Documented hypersensitivity; nonsmokers, children, pregnancy, life-threatening arrhythmias, severe or worsening angina pectoris
Pregnancy
B - Fetal risk not confirmed in studies in humans but has been shown in some studies in animals
Precautions
Caution in peptic ulcer, coronary artery disease, angina, hypertension, peripheral arterial disease, diabetes, severe renal dysfunction, and hepatic dysfunction; dental problems may become exacerbated with this dosage form
Nicotine replacement therapy (nasal spray)
Provides nicotine delivery through nasal mucosa
Nicotine polacrilex nasal spray (Nicotrol NS)
Intranasal nicotine may closely approximate time course of plasma nicotine levels observed after cigarette smoking.
Adult
1-2 puff/h, each spray contains 0.5 mg of nicotine, not to exceed more than 10 puff/h (5 mg)
Pediatric
Not established
May decrease diuretic effects of furosemide and decrease cardiac output; may decrease absorption of glutethimide; may increase circulating cortisol and catecholamines; do not use if patient continues to smoke, use snuff, chew tobacco, or use other nicotine products because may increase toxicity of nicotine
Documented hypersensitivity; nonsmokers, children, pregnancy, life-threatening arrhythmias, severe or worsening angina pectoris
Pregnancy
D - Fetal risk shown in humans; use only if benefits outweigh risk to fetus
Precautions
Caution in peptic ulcer, coronary artery disease, angina, hypertension, peripheral arterial disease, diabetes, severe renal dysfunction, and hepatic dysfunction
Nicotine replacement therapy (inhaler)
Delivers nicotine through oral mucosa.
Nicotine polacrilex inhaler (Nicotrol Inhaler)
Quickly absorbed and closely approximates time course of plasma nicotine levels observed after cigarette smoking.
Adult
Each inhaler cartridge delivers 4 mg of nicotine; once activated, may be used over several min to simulate smoking, although drug generally is absorbed from oral mucosa
Pediatric
Not established
May decrease diuretic effects of furosemide and decrease cardiac output; may decrease absorption of glutethimide; may increase circulating cortisol and catecholamines; do not use if patient continues to smoke, use snuff, chew tobacco, or use other nicotine products because may increase toxicity of nicotine
Documented hypersensitivity; nonsmokers, children, pregnancy, life-threatening arrhythmias, severe or worsening angina pectoris
Pregnancy
X - Contraindicated; benefit does not outweigh risk
Precautions
Caution in peptic ulcer, coronary artery disease, angina, hypertension, peripheral arterial disease, diabetes, severe renal dysfunction, and hepatic dysfunction
Antidepressants
The drug bupropion is used as a non–nicotine-containing aid to smoking cessation. Acts by enhancing the central nervous nonadrenergic function. A recent study demonstrated a 23% sustained cessation rate with bupropion tablets at 1 year, compared to a 12% sustained cessation rate with placebo. Bupropion also is effective for patients in whom nicotine replacement therapy fails.
Bupropion hydrochloride (Zyban)
Used in conjunction with a support group and/or behavioral counseling. Inhibits neuronal dopamine reuptake in addition to being a weak blocker of serotonin and norepinephrine reuptake.
Adult
150-mg tab PO qd for 3 d, then increase to 150 mg PO bid with at least 8 h between each dose for 7-12 wk
Pediatric
Not established
Carbamazepine, cimetidine, phenytoin, and phenobarbital may decrease effects; toxicity increases with concurrent administration of levodopa and MAOIs
Documented hypersensitivity; seizure disorder, anorexia nervosa, concurrent use with MAOIs
Pregnancy
B - Fetal risk not confirmed in studies in humans but has been shown in some studies in animals
Precautions
Caution in renal or hepatic insufficiency; doses >450 mg/d significantly decrease seizure threshold; pruritus, angioedema, dyspnea, insomnia, and delusions and/or hallucinations may occur in depressed patients
Nicotinic acetylcholine receptor partial agonists
Bind to nicotine receptors and elicit mild nicotine central effects to ease withdrawal symptoms. Also decrease stimulatory effect from consuming nicotine products by blocking nicotine receptors.
Varenicline (Chantix)
Partial agonist selective for alpha4, beta2 nicotinic acetylcholine receptors. Action is thought to result from activity at a nicotinic receptor subtype, where its binding produces agonist activity while simultaneously preventing nicotine binding. Agonistic activity is significantly lower than nicotine. Also elicits moderate affinity for 5-HT3 receptors. Maximum plasma concentrations occur within 3-4 h after oral administration. Following regular dosing, steady state reached within 4 d.
Adult
Initiate 1 wk before date chosen to stop smoking
Days 1-3: 0.5 mg PO qd pc
Days 4-7: 0.5 mg PO bid pc
Day 8 to end of treatment: 1 mg PO bid pc
Continue treatment for 12 wk; if successfully stopped smoking at end of 12 wk, an additional 12-wk course is recommended; take pc with full glass of water
Severe renal impairment (ie, CrCl <30 mL/min): Not to exceed 0.5 mg PO bid
End-stage renal disease (ESRD) with hemodialysis: Not to exceed 0.5 mg PO qd
Pediatric
<18 years: Not established
Data limited; coadministration with nicotine replacement therapy (NRT) may increase incidence of nausea, headache, vomiting, dizziness, and dyspepsia compared with NRT alone
Documented hypersensitivity
Pregnancy
C - Fetal risk revealed in studies in animals but not established or not studied in humans; may use if benefits outweigh risk to fetus
Precautions
Common adverse effects include nausea, headache, vomiting, flatulence, insomnia, abnormal dreams, and dysgeusia; decrease dose with severe renal impairment (ie, CrCl <30 mL/min) or ESRD undergoing hemodialysis;
Serious neuropsychiatric symptoms have been reported during postmarketing surveillance and may include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide; these adverse events have been exhibited in patients without pre-existing psychiatric illness, and patients with pre-existing psychiatric illness have reported worsening symptoms during varenicline treatment; for more information, see the FDA MedWatch Safety Information
More on Nicotine Addiction |
| Overview: Nicotine Addiction |
| Differential Diagnoses & Workup: Nicotine Addiction |
 Treatment & Medication: Nicotine Addiction |
| Follow-up: Nicotine Addiction |
| Multimedia: Nicotine Addiction |
| References |
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Further Reading
Keywords
smoking cessation, lung cancer, cigarettes, cigarette smoking, chronic obstructive pulmonary disease, COPD, emphysema, atherosclerotic vascular disease, atherosclerosis, nicotine addition, quitting smoking, tobacco addiction, lung disease
