Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Psychiatry/Psychology
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Zyban Sustained-Release Tablets
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved May 1997
Treatment Area: smoking cessation
Zyban Sustained-Release Tablets have been approved for use as a
smoking cessation treatment. It is the first nicotine-free
prescription medicine available. It is also the first smoking
cessation treatment available in tablet form. Zyban will be
available by prescription approximately July 1997.
In addition, the medication includes a patient support program
Zyban Advantage Plan--at no additional patient cost. The plan
provides additional support and specific smoking cessation
The effectiveness of Zyban as an aid to smoking cessation was
demonstrated in two placebo-controlled, double-blind studies. Over
1,500 chronic smokers who smoked at least 15 cigarettes a day
participated in these studies. In one study, Zyban was compared to
placebo; in the other study, Zyban was evaluated versus placebo, a
nicotine patch (Habitrol (R)(1)), and in combination with the
patch. In both studies, all patients received brief individual
smoking cessation counseling.
In the study involving the patch, patients treated with Zyban
had significantly higher 4-week quit rates than those treated with
the patch. Patients treated with the combination of Zyban and the
patch had significantly higher quit rates than those treated with
the patch alone. Quit rates with combination therapy, while higher,
were not statistically higher than quit rates with Zyban alone. The
4-week quit rates from this study were 23% for placebo; 36% for the
patch; 49% for Zyban; and 58% for the combination of Zyban and the
For many patients, treatment with Zyban reduced withdrawal
symptoms. Withdrawal symptoms showing the most pronounced
reductions were: irritability, frustration or anger, anxiety,
difficulty concentrating, restlessness, and depressed mood or
negative affect. In patients treated with Zyban there was also
evidence of a reduction in craving for cigarettes or urge to
The most common side effects associated with the use of Zyban
are dry mouth and insomnia. These side effects are reported to be
generally mild, and often disappear after a few weeks. The use of
Zyban is also associated with a dose-dependent risk of seizure.
Higher than recommended doses should not be prescribed.
Zyban should not be used in people who are already taking
Wellbutrin(R), Wellbutrin(R) SR, or any other medication that
contains bupropion. It should also not be used in people who are
taking or have recently taken a monoamine oxidase inhibitor (MAOI).
Zyban should not be used in patients with a seizure disorder who
have a history, or are currently diagnosed with bulimia or anorexia
Mechanism of Action
Currently, it is unclear how Zyban works. However, it does
affect noradrenergic and/or dopaminergic mechanisms in the brain,
which have been implicated as pathways of nictotine addiction.