Nortriptyline has been tested in eight trials and found efficacious (Hughes et al. 2007; Hughes et al. 2005). Again the FDA warning on nortriptyline was not due to direct data but simply because nortriptyline is an antidepressant (US Food and Drug Administration 2007a). No reports of suicidal behavior or overdoses were reported in the RCTs of nortriptyline for smoking cessation, but combined together, they represent only about 500 smokers exposed to nortriptyline.
