Considering quitting tobacco? What you should know about Zyban.

On April 10, 2011, in Opinion, by Smokey the Barrister

zyban Zyban is a prescription medication designed to help smokers quit more easily than without the drug. It comes in a pill form. It does not contain nicotine

Zyban’s history is interesting. Smokers who happened to be users of the anti-depression medication Wellbutrin (bupropion hydrochloride) often reported a lessening in the desire for cigarettes. Through further testing, the drug was found to be effective in treating the smoking addiction, and helping smokers quit. GlaxoSmithKline “repackaged” Wellbutrin and marketed it as the smoking-cessation drug Zyban.

Unlike nicotine patches or nicotine gum, Zyban does not put more nicotine into your body. If you use the patches or gum, you should stop smoking so that you don’t “overdose” on nicotine. With Zyban, you continue to smoke when you first start taking the medication, eventually reaching a quit-date, and taking the drug for a period of time after quitting.

Before taking Zyban, smokers want to know what Zyban will do to make quitting easier. According to the results reported during clinical trials, “treatment with ZYBAN reduced withdrawal symptoms compared to placebo. Reductions on the following withdrawal symptoms were most pronounced: irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; and depressed mood or negative affect. Depending on the study and the measure used, treatment with ZYBAN showed evidence of reduction in craving for cigarettes or urge to smoke compared to placebo.”

Zyban is not without side-effects. According the the Zyban website, “The most common side effects experienced with ZYBAN include dry mouth and difficulty sleeping. There are other risks associated with the use of ZYBAN, so it is important to talk to your healthcare professional to see whether ZYBAN is right for you. There is a risk of seizure associated with ZYBAN, which is increased in certain patients.”

Zyban has proven more effective than placebo in clinical testing, with success rates ranging as high as 58% in one study. Most studies showed success rates at somewhere between 15%-25%. Long-term success rates are obviously on the lower end, as smokers tend to relapse after longer periods of time. Some studies included using Zyban in conjunction with nicotine patches.

Because medications such as Zyban have potential dangers and side-effects, the full text from the Zyban web-site quoted here:

CONTRAINDICATIONS
ZYBAN is contraindicated in patients with a seizure disorder.
ZYBAN is contraindicated in patients treated with WELLBUTRIN, WELLBUTRIN SR, or
any other medications that contain bupropion because the incidence of seizure is dose dependent.
ZYBAN is contraindicated in patients with a current or prior diagnosis of bulimia or anorexia
nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the
immediate-release formulation of bupropion.
ZYBAN is contraindicated in patients undergoing abrupt discontinuation of alcohol or
sedatives (including benzodiazepines).
The concurrent administration of ZYBAN and a monoamine oxidase (MAO) inhibitor is
contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and
initiation of treatment with ZYBAN.
ZYBAN is contraindicated in patients who have shown an allergic response to bupropion or
the other ingredients that make up ZYBAN.

WARNINGS
Patients should be made aware that ZYBAN contains the same active ingredient found
in WELLBUTRIN and WELLBUTRIN SR used to treat depression, and that ZYBAN
should not be used in combination with WELLBUTRIN, WELLBUTRIN SR, or any other
medications that contain bupropion.

Don't take this and Zyban together.

Because the use of bupropion is associated with a dose-dependent risk of seizures,
clinicians should not prescribe doses over 300 mg/day for smoking cessation. The risk of
seizures is also related to patient factors, clinical situation, and concurrent medications,
which must be considered in selection of patients for therapy with ZYBAN. ZYBAN should
be discontinued and not restarted in patients who experience a seizure while on treatment.
• Dose: For smoking cessation, doses above 300 mg/day should not be used. The seizure
rate associated with doses of sustained-release bupropion up to 300 mg/day is
approximately 0.1% (1/1,000). This incidence was prospectively determined during an
8-week treatment exposure in approximately 3,100 depressed patients. Data for the
immediate-release formulation of bupropion revealed a seizure incidence of
approximately 0.4% (4/1,000) in depressed patients treated at doses in a range of 300 to
450 mg/day. In addition, the estimated seizure incidence increases almost tenfold
between 450 and 600 mg/day.
• Patient factors: Predisposing factors that may increase the risk of seizure with
bupropion use include history of head trauma or prior seizure, central nervous system
(CNS) tumor, the presence of severe hepatic cirrhosis, and concomitant medications
that lower seizure threshold.
• Clinical situations: Circumstances associated with an increased seizure risk include,
among others, excessive use of alcohol or sedatives (including benzodiazepines);
addiction to opiates, cocaine, or stimulants; use of over-the-counter stimulants and
anorectics; and diabetes treated with oral hypoglycemics or insulin.
• Concomitant medications: Many medications (e.g., antipsychotics, antidepressants,
theophylline, systemic steroids) are known to lower seizure threshold.
Recommendations for Reducing the Risk of Seizure: Retrospective analysis of clinical
experience gained during the development of bupropion suggests that the risk of seizure
may be minimized if
• the total daily dose of ZYBAN does not exceed 300 mg (the maximum recommended
dose for smoking cessation), and
• the recommended daily dose for most patients (300 mg/day) is administered in divided
doses (150 mg twice daily).
• No single dose should exceed 150 mg to avoid high peak concentrations of bupropion
and/or its metabolites.
ZYBAN should be administered with extreme caution to patients with a history of
seizure, cranial trauma, or other predisposition(s) toward seizure, or patients treated with
other agents (e.g., antipsychotics, antidepressants, theophylline, systemic steroids, etc.) that
lower seizure threshold.
Hepatic Impairment: ZYBAN should be used with extreme caution in patients with severe
hepatic cirrhosis. In these patients a reduced frequency of dosing is required, as peak
bupropion levels are substantially increased and accumulation is likely to occur in such
patients to a greater extent than usual. The dose should not exceed 150 mg every other day
in these patients (see CLINICAL PHARMACOLOGY, PRECAUTIONS, and DOSAGE
AND ADMINISTRATION).