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Wellbutrin XL (Bupropion Hydrochloride) - Summary

 
 



WARNING

Suicidality and Antidepressant Drugs

Use in Treating Psychiatric Disorders: 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 XL®* 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 XL is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk in Treating Psychiatric Disorders, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use.)

Use in Smoking Cessation Treatment: WELLBUTRIN®*, WELLBUTRIN SR and WELLBUTRIN XL are not approved for smoking cessation treatment, but bupropion under the name ZYBAN®* is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking bupropion who continued to smoke.

All patients treated with Bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking ZYBAN in the post-marketing experience. When symptoms were reported, most were during treatment with ZYBAN, but some were following discontinuation of treatment with ZYBAN. These events have occurred in patients with and without pre-existing psychiatric disease; some have experienced worsening of their psychiatric illnesses.

Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of ZYBAN.

Advise patients and caregivers that the patient using bupropion for smoking cessation should stop taking bupropion and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in thinking or behavior that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of ZYBAN was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of using bupropion for smoking cessation should be weighed against the benefits of its use. ZYBAN has been demonstrated to increase the likelihood of abstinence from smoking for as long as six months compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial. (See WARNINGS: Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment and PRECAUTIONS: Information for Patients.)

 

WELLBUTRIN XL SUMMARY

WARNING

WELLBUTRIN XL (bupropion hydrochloride), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents.

Major Depressive Disorder: WELLBUTRIN XL is indicated for the treatment of major depressive disorder.

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

A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 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 bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see CLINICAL TRIALS). Nevertheless, the physician who elects to use WELLBUTRIN XL for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Seasonal Affective Disorder: WELLBUTRIN XL is indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.

The efficacy of WELLBUTRIN XL for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see CLINICAL TRIALS).

Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of non-seasonal episodes during the individual's lifetime.


See all Wellbutrin XL indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Wellbutrin XL (Bupropion)

SSRI versus bupropion effects on symptom clusters in suicidal depression: post hoc analysis of a randomized clinical trial. [2013]
CONCLUSIONS: The results require replication but suggest a pathway by which

Bupropion for smoking cessation in patients hospitalized with acute myocardial infarction: a randomized, placebo-controlled trial. [2013]
patients with acute myocardial infarction (AMI)... CONCLUSIONS: Two-thirds of patients return to smoking by 12 months after AMI.

The DRD4 exon III VNTR, bupropion, and associations with prospective abstinence. [2013]
cognitive-behavioral mood management therapy... CONCLUSIONS: VNTR by treatment interaction differences between these and previous

Sustained-release bupropion for smoking cessation in a Chinese sample: a double-blind, placebo-controlled, randomized trial. [2013]
population... CONCLUSION: Bup-SR is efficacious for smoking cessation in healthy Chinese

The DRD4 Exon III VNTR, Bupropion, and Associations With Prospective Abstinence. [2012]
cognitive-behavioral mood management therapy... CONCLUSIONS: VNTR by treatment interaction

more studies >>

Clinical Trials Related to Wellbutrin XL (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.

Bupropion Hydrochloride 300 mg Extended Release Tablets Under Fasting Conditions [Recruiting]
The objective of this study is to evaluate the comparative bioavailability between bupropion hydrochloride 300 mg extended release tablets (Teva Pharmaceuticals USA) and Wellbutrin XL® 300 mg extended release tablets (Biovail Pharmaceuticals, Inc.) at steady-state in patients under fasting conditions.

Zyban as an Effective Smoking Cessation Aid for Patients Following an Acute Coronary Syndrome: The ZESCA Trial [Recruiting]
Patients who continue to smoke after a heart attack have a 35% increased risk of a recurrent event or death compared with those who quit. Many patients attempt to stop smoking after a heart attack, but relapse rates approach 66%. A variety of smoking cessation aids have been shown to be effective for the general population. However, bupropion is the only non-nicotine replacement therapy shown to improve abstinence rates in healthy young smokers. Furthermore, nicotine replacement therapies (NRTs) are contraindicated in the immediate period following a heart attack because of the undesirable effects of nicotine. Although bupropion has been successfully used to reduce smoking rates in healthy young populations, its efficacy and safety in the setting of patients recovering from an ACS is unknown. These patients, if they continue to smoke, are at exceptionally high risk for recurrent cardiac events. If bupropion is effective in this population, it will have a major impact on secondary prevention of recurrent clinical events in patients who suffer a heart attack.

The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior [Recruiting]
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.

more trials >>

Reports of Suspected Wellbutrin XL (Bupropion) Side Effects

Convulsion (21)Drug Ineffective (19)Depression (19)Product Quality Issue (14)Anxiety (13)Tremor (11)Agitation (10)Product Substitution Issue (10)Dizziness (10)Confusional State (9)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 35 ratings/reviews, Wellbutrin XL has an overall score of 7.97. The effectiveness score is 7.94 and the side effect score is 7.83. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Wellbutrin XL review by 49 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   anti-depressant
Dosage & duration:   350 (dosage frequency: once a day) for the period of 2 years
Other conditions:   n/a
Other drugs taken:   none
  
Reported Results
Benefits:   The biggest benefit was when I quit smoking, because I had been taking it for a while...it proved to assist with the cravings...it's probably why I was able to quit in the first place.
Side effects:   Made me kind of grumpy and a little weight gain.
Comments:   Started taking anti-depressant when my Mother passed away. Started a low-dose and increased over a period of 3 months. I believe Wellbuterin was very beneficial and did not have major side effects. I stopped taking them 2 months ago and haven't had any withdrawal symptoms.

 

Wellbutrin XL review by 56 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   150mg taken every am for the period of on going
Other conditions:   thyroid, high cholesterol
Other drugs taken:   Synthroid 25mg Simvastaton 20mg
  
Reported Results
Benefits:   Yes, I had taken Prozac for fourteen to fifteen years for the treatment of depession and experienced a loss of sexual desire. I tried the Wellbutrin XL in the hopes that it would not produce this side effect starting about 18 months ago. The Wellbutrin XL does not have this side effect in my experience.
Side effects:   I have not noticed side effects. I was hoping that a good side effect would be that it would help me quit smoking. It hasn't.
Comments:   I don't have any details. Have thought about asking my doctor to up the dosage when I was having a bout of feeling "down" but it passed and I didn't.

 

Wellbutrin XL review by 53 year old female patient

  Rating
Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Severe Side Effects
  
Treatment Info
Condition / reason:   lose weight
Dosage & duration:   300mg taken 1x day for the period of 2 weeks
Other conditions:   none
Other drugs taken:   none
  
Reported Results
Benefits:   Positive- increased libido
Side effects:   Negative- 1)significant increase in breast pain on one side, leading to bloody discharge after only 2 weeks of taking drug 2)'coursing' feeling through veins on same side as breast pain 3)humongous hard pimple formed near nose.
Comments:   Discontinued treatment due to side effects. I would consider taking again if the negative side effects were noted in literature as temporary and insignificant over the long term

See all Wellbutrin XL reviews / ratings >>

Page last updated: 2014-11-30

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