263    Table 1. Incidence of Agitation, Anxiety, and Insomnia in Placebo-Controlled Trials

Adverse Event Term	WELLBUTRIN SR 300 mg/day (n=376)	WELLBUTRIN SR 400 mg/day (n=114)	Placebo (n=385)
Agitation Anxiety Insomnia	3% 5% 11%	9% 6% 16%	2% 3% 6%

 

264     

265         In clinical studies, these symptoms were sometimes of sufficient magnitude to require

266    treatment with sedative/hypnotic drugs.

267         Symptoms were sufficiently severe to require discontinuation of treatment in 1% to 2.6% of

268    patients treated with 300 and 400 mg/day, respectively, of bupropion sustained-release tablets

269    and 0.8% of patients treated with placebo.

270         Psychosis, Confusion, and Other Neuropsychiatric Phenomena:  Depressed

271    patients treated with bupropion have been reported to show a variety of neuropsychiatric signs

272    and symptoms, including delusions, hallucinations, psychosis, concentration disturbance,

273    paranoia, and confusion.  In some cases, these symptoms abated upon dose reduction and/or

274    withdrawal of treatment.

275        Activation of Psychosis and/or Mania:  Antidepressants can precipitate manic episodes

276    In bipolar disorder patients during the depressed phase of their illness and may active latent

277    psychosis in other susceptible patients.  WELLBUTRIN XL is expected to pose similar risks.

278         Altered Appetite and Weight:  In placebo-controlled studies using WELLBUTRIN SR,

279    the sustained-release formulation of bupropion, patients experienced weight gain or weight loss

280    as shown in Table 2.

281     

282    Table 2. Incidence of Weight Gain and Weight Loss in Place-Controlled Trials

 

Weight Change	WELLBUTRIN SR 300 mg/day (n=339)	WELLBUTRIN SR 400 mg/day (n=112)	Placebo (n=347)
Gained > 5 lbs Lost >5 lbs	3% 14%	2% 19%	4% 6%

283     

284         In studies conducted with the immediate-release formulation of bupropion, 35% of patients

285    receiving tricyclic antidepressants gained weight, compared to 9% of patients treated with the

286    immediate-release formulation of bupropion.  If weight loss is a major presenting sign of a

287    patient’s depressive illness, the anorectic and/or weight-reducing potential of

288    WELLBUTRIN XL Tablets should be considered.

289         Suicide:  The possibility of a suicide attempt is inherent in depression and may persist until

290    significant remission occurs.  According, prescriptions for WELLBUTRIN XL Tablets should

291    be written for the smallest number of tablets consistent with good patient management.

 

 

 

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