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Wellbutrin SR (Bupropion Hydrochloride) - Summary

 



Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of WELLBUTRIN SR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. WELLBUTRIN SR is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

 

WELLBUTRIN SR SUMMARY

WELLBUTRIN SR®
(bupropion hydrochloride)
Sustained-Release Tablets

WELLBUTRIN SR (bupropion hydrochloride), an antidepressant of the aminoketone class, is 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 designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride.

WELLBUTRIN SR is indicated for the treatment of depression.

The efficacy of bupropion in the treatment of depression was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least five of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of WELLBUTRIN SR in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use WELLBUTRIN SR for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.


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NEWS HIGHLIGHTS

Published Studies Related to Wellbutrin SR (Bupropion)

The impact of chronic bupropion on plasma cotinine and on the subjective effects of ad lib smoking: A randomized controlled trial in unmotivated smokers. [2009.09.14]
Bupropion is an efficacious non-nicotine medication for smoking cessation; however, its cessation-mediating mechanism is unclear. This randomized, placebo-controlled trial examined the effect of bupropion SR (300mg/day for 6weeks) on plasma cotinine and on the subjective effects of smoking in 24 current daily smokers who were not trying to quit or reduce smoking...

A randomized, controlled trial of bupropion sustained-release for preventing tobacco relapse in recovering alcoholics. [2009.07]
INTRODUCTION: Studies examining the efficacy of tobacco dependence treatment among recovering alcoholic smokers have produced mixed findings... DISCUSSION: Treatment with bupropion SR among abstinent alcoholic smokers did not delay relapse or result in improved long-term smoking abstinence.

A preliminary trial: double-blind comparison of nefazodone, bupropion-SR, and placebo in the treatment of cannabis dependence. [2009.01]
The present study investigated the efficacy of nefazodone and bupropion-sustained release for treating cannabis dependence. A double-blind, placebo-controlled, piggy back design was employed to assess if nefazodone and bupropion-sustained release increased the probability of abstinence from cannabis and reduced the severity of cannabis dependence and cannabis withdrawal symptoms during a 13-week outpatient treatment program...

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 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)...

A randomized trial of short psychotherapy versus sustained-release bupropion for smoking cessation. [2008.12]
AIMS: To compare the efficacy and safety of a novel psychological intervention for smoking cessation called psychodynamic model (PDM) training to an active control condition of sustained-release bupropion... CONCLUSIONS: The 1.5-day psychotherapy exceeded bupropion's efficacy, presenting an alternative to pharmacological smoking cessation aids, especially for smokers who reject drugs to treat their substance dependence, at a similar cost (Euro 350) as the bupropion treatment (Euro 355).

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Clinical Trials Related to Wellbutrin SR (Bupropion)

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

- To evaluate the efficacy of bupropion extended release (Wellbutrin XLâ„¢) in the treatment

of Major Depressive Disorder in women with breast cancer.

- To evaluate the tolerability of bupropion extended-release (Wellbutrin XLâ„¢) 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.

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.

Wellbutrin XL for Dysthymic Disorder [Completed]
This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.

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PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 8 ratings/reviews, Wellbutrin SR has an overall score of 8.38. The effectiveness score is 8.25 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Wellbutrin SR review by 45 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   200 mg taken 1x am for the period of 24 months
Other conditions:   N/A
Other drugs taken:   trazadone
  
Reported Results
Benefits:   I began to notice the positive benefits within a few weeks. My mood brightened, I stopped feeling grief and self-loathing, began to remember what I liked to do. I also had increased ability to concentrate, increased energy, increased sex drive. I was no longer depressed. I stopped taking the medication after a couple of years, and the symptoms of depression did not return.
Side effects:   I actually felt pretty upset during the first couple of weeks - shaky, a little manic and sensitive. That did go away, though. I also had occasional insomnia throughout.
Comments:   I met with my physician four weeks after I began taking the medication, then 3 months later, then every six months. I did not attend talk therapy or receive any other treatment.

 

Wellbutrin SR review by 55 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   1 per day 150 mg SR taken daily for the period of 7yrs
Other conditions:   acid reflux
Other drugs taken:   Prilosec; Effexor
  
Reported Results
Benefits:   It helped with depression and suicidal thoughts. I was able to sleep better and deal with anxiety and stress better.
Side effects:   dry mouth was the worst side effect but since I should drink more water anyway it was a mixed blessing.
Comments:   Effexor and Wellbutrin kept my depression under control - I took more during the winter months and less the rest of the year.

 

Wellbutrin SR review by 41 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   150 mg x2 daily taken morning and bight for the period of 3 months
Other conditions:   menopausal
Other drugs taken:   premarin
  
Reported Results
Benefits:   i dont think i felt anything positive, no mood change, just the same really although i am smoking a lot less, it does a good job of taking away cravings for nicotine
Side effects:   anxiety, anxiety, anxiety
Comments:   to take 2 daily, the results are meant to be felt about 1 month after starting treatment

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Page last updated: 2009-10-20

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