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Modafinil: new indications for wake promotion.

In January 2004, the wake-promoting agent, modafinil, was approved in the US for the treatment of excessive sleepiness (ES) associated with obstructive sleep apnoea/hypopnoea syndrome (OSAHS) and shift-work sleep disorder (SWSD), representing an expansion of its labelling from the initial indication for ES associated with narcolepsy. A total of five randomised, placebo-controlled studies in these three disorders showed statistically significant benefits on various objective measures and subjective estimates of ES, including the Multiple Sleep Latency Test, Maintenance of Wakefulness Test, Epworth Sleepiness Scale and Karolinska Sleepiness Scale. Significant improvement was also seen in overall clinical condition (on the Clinical Global Impression of Change) and measures of sustained attention and reaction time (on the Psychomotor Vigilance Task). The clinical efficacy of modafinil, combined with improved safety over CNS stimulants, has made it the most prescribed medication for the treatment of ES associated with narcolepsy. Modafinil is the only medication approved for ES associated with OSAHS and SWSD (for OSAHS, it is indicated as an adjunct to standard treatments for the under-lying obstruction). Unlike many other medications used for ES, modafinil is not known to be abused. The most common adverse event reported in clinical studies was headaches; most were transient and mild-to-moderate in severity. Modafinil also has the potential for interactions with other drugs metabolised via cytochrome P450 enzyme pathways. Potential obstacles to the use of modafinil include an under-recognition of ES and its consequences. Increased education, both of the public and the medical community, should improve the recognition and therapy of ES.

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