OBJECTIVE: To report the successful use of lisdexamfetamine in the management of narcolepsy.
METHODS: Five narcoleptic patients received lisdexamfetamine, at different dosages and for different periods, for management of excessive daytime sleepiness and weight control.
RESULTS: All patients experienced improvement of excessive daytime sleepiness and lost weight without side effects.
CONCLUSIONS: Lisdexamfetamine appears promising for the treatment of two of the most common symptoms of narcolepsy: excessive daytime sleepiness and weight gain.

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Psychostimulants have been assessed in bulimia nervosa patients with comorbid attention deficit/hyperactivity disorder (ADHD), but few studies have examined the impact of psychostimulants on bulimia nervosa patients without comorbid ADHD. The aim of this study was to examine psychostimulants as a potential treatment for bulimia nervosa and to assess the concern of weight loss, given the medication\'s appetite-suppressing effects. This retrospective study describes 6 case reports of outpatients who were prescribed a psychostimulant specifically for their bulimia nervosa. The number of binge/purge days per months and body mass index were assessed. All patients demonstrated reductions in the number of binge/purge days per month, and 1 patient experienced total remission of bulimic symptoms. Minor fluctuations in weight were observed, but no clinically significant reductions in weight were noted. These findings support the need for clinical trials to examine the efficacy and safety of this potential treatment.

The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).