Management of
narcolepsy with or without
cataplexy relies on several classes of drugs, namely stimulants for
excessive daytime sleepiness and irresistible episodes of sleep,
antidepressants for
cataplexy and hypnosedative drugs for disturbed nocturnal sleep. In addition, behavioral measures can be of notable value. Guidelines on the management of
narcolepsy have already been published. However contemporary guidelines are necessary given the growing use of
modafinil to treat
excessive daytime sleepiness in Europe within the last 5-10 years, and the decreasing need for
amphetamines and
amphetamine-like stimulants; the extensive use of new
antidepressants in the treatment of
cataplexy, apart from consistent randomized placebo-controlled clinical trials; and the present re-emergence of
gamma-hydroxybutyrate under the name
sodium oxybate, as a treatment of all major symptoms of
narcolepsy. A task force composed of the leading specialists of
narcolepsy in Europe has been appointed. This task force conducted an extensive review of pharmacological and behavioral trials available in the literature. All trials were analyzed according to their class evidence. Recommendations concerning the treatment of each single symptom of
narcolepsy as well as general recommendations were made.
Modafinil is the first-line pharmacological treatment of
excessive daytime sleepiness and irresistible episodes of sleep in association with behavioral measures. However, based on several large randomized controlled trials showing the activity of
sodium oxybate, not only on
cataplexy but also on
excessive daytime sleepiness and irresistible episodes of sleep, there is a growing practice in the USA to use it for the later indications. Given the availability of
modafinil and
methylphenidate, and the forseen registration of
sodium oxybate for
narcolepsy (including
excessive daytime sleepiness,
cataplexy, disturbed nocturnal sleep) in Europe, the place of other compounds will become fairly limited. Since its recent registration
cataplexy sodium oxybate has now become the first-line treatment of
cataplexy. Second-line treatments are
antidepressants, either tricyclics or newer
antidepressants, the later being increasingly used these past years despite few or no randomized placebo-controlled clinical trials. As for disturbed nocturnal sleep the best option is still
hypnotics until
sodium oxybate is registered for
narcolepsy. The treatments used for
narcolepsy, either pharmacological or behavioral, are diverse. However the quality of the published clinical evidences supporting them varies widely and studies comparing the efficacy of different substances are lacking. Several treatments are used on an empirical basis, specially
antidepressants for
cataplexy, due to the fact that these medications are already used widely in depressed patients, leaving little motivation from the manufacturers to investigate efficacy in relatively rare indications. Others, in particular the more recently developed substances, such as
modafinil or
sodium oxybate, are evaluated in large randomized placebo-controlled trials. Our objective was to reinforce the use of those drugs evaluated in randomized placebo-controlled trials and to reach a consensus, as much as possible, on the use of other available medications.