Zyban (Bupropion Hydrochloride) - Summary

ZYBAN SUMMARY

ZYBAN (bupropion hydrochloride) Sustained-Release Tablets are a non-nicotine aid to smoking cessation. ZYBAN is chemically unrelated to nicotine or other agents currently used in the treatment of nicotine addiction. Initially developed and marketed as an antidepressant (WELLBUTRIN® [bupropion hydrochloride] Tablets and WELLBUTRIN SR® [bupropion hydrochloride] Sustained-Release Tablets), ZYBAN is also chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.

ZYBAN is indicated as an aid to smoking cessation treatment.

See all Zyban indications & dosage >>

ZYBAN NEWS HIGHLIGHTS

Media Articles Related to Zyban (Bupropion)

Popular Stop-Smoking Drugs to Carry Mental Health Risk Warnings
Source: MedPage Today Primary Care [2009.07.01]
WASHINGTON (MedPage Today) -- The FDA announced that it will require the labels of varenicline (Chantix) and bupropion (Zyban, Wellbutrin, and generics) to carry boxed warnings on the risk of serious neuropsychiatric symptoms starting today.

Anti-Smoking Drugs Get FDA 'Black-Box' Warning (HealthDay)
Source: Y! Health Depression News [2009.07.01]
HealthDay - WEDNESDAY, July 1 (HealthDay News) -- Two drugs prescribed to help people quit smoking, Chantix and Zyban, will now carry "black-box" warnings on the potential risks of psychiatric problems, including depression and suicidal thoughts, U.S. health officials said Wednesday.

Intensive In-Hospital Support Doubles Likelihood Of Smoking Cessation In Heart Patients
Source: Smoking / Quit Smoking News From Medical News Today [2009.06.23]
Patients admitted to hospital with coronary artery disease are twice as likely to quit smoking after receiving intensive smoking cessation support compared to minimal support, found a new study in CMAJ (Canadian Medical Association Journal).

Inhospital Push for Smoking Cessation Boosts Heart Patient Quit Rates (CME/CE)
Source: MedPage Today Pulmonary [2009.06.22]
SAN FRANCISCO (MedPage Today) -- Heavy emphasis on smoking cessation while patients are in the hospital recovering from coronary artery bypass surgery or acute MI doubles long-term quit rates, researchers found.

Pfizer Updates CHANTIX(R) (varenicline) Labeling In The United States
Source: Health News from Medical News Today [2009.07.02]
Pfizer Inc announced that it has updated the U.S. product labeling for CHANTIX® (varenicline), a prescription aid to smoking cessation treatment, to communicate important safety information in a boxed warning as well as in revised warnings and precautions. These updates are based on post-marketing reports and are being made in agreement with the U.S. Food and Drug Administration (FDA).

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Published Studies Related to Zyban (Bupropion)

A controlled trial of bupropion added to nicotine patch and behavioral therapy for smoking cessation in adults with unipolar depressive disorders. [2008.12]
Although there is a strong relationship between depression and smoking, most nicotine dependence treatment trials exclude depressed smokers. Our objective was to determine whether bupropion [generic for Zyban] improves abstinence rates and abstinence-associated depressive symptoms when added to transdermal nicotine replacement therapy (NRT) and group cognitive behavioral therapy (CBT) in smokers with unipolar depressive disorder (UDD)...

Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis. [2008.11]
OBJECTIVES: To evaluate varenicline's efficacy for smoking cessation versus bupropion [generic for Zyban] SR and placebo and to explore whether factors typically predictive of abstinence influence varenicline's efficacy versus placebo, as measured by the week 9-12 continuous abstinence rate (CAR9-12)... CONCLUSIONS: Varenicline was more efficacious than bupropion SR or placebo. Varenicline's efficacy versus placebo was not influenced by factors predictive of abstinence.

Psychological mediators of bupropion sustained-release treatment for smoking cessation. [2008.09]
AIM: The study aimed to test simultaneously our understanding of the effects of bupropion [generic for Zyban] sustained-release (SR) treatment on putative mediators and our understanding of determinants of post-quit abstinence, including withdrawal distress, cigarette craving, positive affect and subjective reactions to cigarettes smoked during a lapse. The specificity of bupropion SR effects was also tested in exploratory analyses... CONCLUSIONS: Results provided some support for models of bupropion SR treatment and relapse and suggested that motivational processes may partially account for bupropion SR efficacy.

Randomized, placebo-controlled trial of bupropion for the treatment of methamphetamine dependence. [2008.08.01]
OBJECTIVE: To compare bupropion [generic for Zyban] to placebo for reducing methamphetamine (MA) use, increasing retention, and reducing the severity of depressive symptoms and MA-cravings. A secondary objective compared bupropion to placebo for reducing cigarette smoking among MA dependent participants... CONCLUSION: Bupropion was no more effective than placebo in reducing MA use in planned analyses, though bupropion did reduce cigarette smoking. Post hoc findings of an effect for bupropion among baseline light, but not heavy, MA users suggests further evaluation of bupropion for light-MA users is warranted.

Efficacy of bupropion and the selective serotonin reuptake inhibitors in the treatment of major depressive disorder with high levels of anxiety (anxious depression): a pooled analysis of 10 studies. [2008.08]
CONCLUSIONS: There appears to be a modest advantage for the SSRIs compared to bupropion [generic for Zyban] in the treatment of anxious depression (6% difference in response rates). Using the number-needed-to-treat (NNT) statistic as 1 indicator of clinical significance, nearly 17 patients would need to be treated with an SSRI than with bupropion in order to obtain 1 additional responder. This difference falls well above the limit of NNT = 10, which was suggested by the United Kingdom's National Institute of Clinical Excellence. Nevertheless, the present work is of theoretical interest because it provides preliminary evidence suggesting a central role for serotonin in the regulation of symptoms of negative affect such as anxiety.

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Clinical Trials Related to Zyban (Bupropion)

Wellbutrin XL, Major Depressive Disorder and Breast Cancer [Completed]

- To evaluate the efficacy of bupropion extended release (Wellbutrin XL™) in the treatment

of Major Depressive Disorder in women with breast cancer.

- To evaluate the tolerability of bupropion extended-release (Wellbutrin XL™) in these

patients

The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity [Completed]
The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL (bupropion hydrochloride) on reward processing.

Randomized Trial of Ultrashort Psychotherapy vs Sustained-Release Bupropion for Smoking Cessation [Completed]
Background

Smokers often reject drugs as smoking cessation aids. Nonpharmacological interventions are notoriously under-evaluated.

Methods

We conducted a randomized clinical trial in which we compared a medication, i. e., sustained-release bupropion (Zyban®; 413 subjects), at the time of the trial the most efficacious pharmacological smoking cessation aid, with an ultrashort psychotherapeutic intervention, Psychodynamic Model Training® (366 subjects), a manual-based psychodynamically oriented 1 ½ day autosuggestion training. Outcome criterion was 12-month self-reported continuous abstinence confirmed by urine cotinine levels below the level of detection (13 ng/ml) or, in an independent analysis, by exhaled carbon monoxide of 10 ppm or less at all interviews conducted at 3, 6, and 12 months.

A Preliminary Study of Sustained-Release Bupropion for Smoking Cessation in Bipolar Affective Disorder [Completed]
The purpose of this pilot study is to determine the safety and potential efficacy of sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients with bipolar affective illness. It is hypothesized that bupropion will produce a significant enhancement of smoking abstinence compared to placebo and will be safe for use in these patients.

Chantix & Bupropion for Smoking Cessation [Active, not recruiting]
The overarching goal of this line of research is to increase smoking abstinence rates using a combination of existing pharmacotherapies. The aim of the current study is to assess the safety and compliance as well as obtain preliminary estimates of efficacy and effect on craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We will compare the efficacy estimates in this study with historical smoking abstinence rates with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an open-label, phase II clinical trial.

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ZYBAN PATIENT REVIEWS / RATINGS / COMMENTS

Zyban review by 36 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		SMOKING CESSATION
Dosage & duration:		150mg/d taken 1xp/d. did not sustain recommended 300mg for the period of approx. 3 months/ 90 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		The treatment seemed to help considerably with the generalized brain 'fuzziness', lack of focus, fatigue and irrational mood swings that I had experienced on every other non-Zyban supported attempt to quit smoking. The treatment dramatically lessened the effect of nicotine withdrawal, or at least its perception, such that any reflexive craving to smoke was manageably overcome until the habit was finally broken.
Side effects:		At 150mg/d side effects were minimal - perhaps a slight boost in energy. In contrast, at 300mg/d - which I could handle for only a short period - I felt "shaky" with restless legs and some insomnia. These problems went away when I reverted to 150mg/d. I feel the treatment was entirely effective at this lower dose, and unmanageably unpleasant at the higher [and recommended!] dose. Perhaps Zyban should revisit their dosing recommendations.
Comments:		I began taking 150mg/d two weeks/ 14 days before my actual quit date. On the quit date, I also started a series of yoga classes and regular physical activity through the first few months of smoking cessation. I decided to continue taking Zyban beyond the recommended period to a full 3 months at 1 dose daily. In my experience, I would recommend a lower daily dosage of 150mg/d for a longer extended period of time given my success in using Zyban in this manner.

Zyban review by 49 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		to quit smoking
Dosage & duration:		don't remember (dosage frequency: once a day) for the period of 3 weeks
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		After taking the Zyban for 3 weeks my desire to smoke was nearly eliminated. I had tried other methods to quit smoking and this one actually worked! Unfortunately I had a severe allergic reactions to the medication (the main ingredient Wellbutrin).
Side effects:		I initially broke out in hives which became so severe I was taken off the Zyban and prescribed a steroid. The allergic reaction internalized and I ended up missing 3 weeks of work do the joint immobility it caused.
Comments:		I was impressed with the ability the medication had with my decreased desire to want to smoke, but the side affects/allergic reaction was to severe to continue using it.

Zyban review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Ineffective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		smoking cessation
Dosage & duration:		150mg taken twice daily for the period of 10 days
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		none
Side effects:		severe anxiety attacks, depression, suicidal thoughts.
Comments:		I had to take 150mg daily for the 1st 5 days, then twice daily. The tablets made me feel very anxious and depressed from day 6 onwards. I experienced a full blown anxiety attack on day 10, with racing thoughts that I could not control, suicidal thoughts, and a feeling that I was about to lose my mind. I had the presence of mind to realise that I was experiencing a reaction to the drug, but had to call a friend to spend the evening with me as I was experiencing a strong urge to kill myself. I discontinued the tablets, and the symptoms went away immediately