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New nonamphetamine drug approved by the FDA for narcolepsy patients

We've all endured our share of snooze attacks in a variety of appropriate settings, such as those memorable three-hour pharmacy school lectures on medicinal chemistry, or the office following a rather large turkey hero lunch. But what if your patient tells you that he suffers from irresistible sleep attacks that occur just about anytime and anywhere? The causes can be many, but one might be a chronic sleep disorder known as narcolepsy.

The condition, known to impair a person's ability to perform basic daily activities by producing excessive daytime sleepiness that can last from a few seconds to more than an hour, has generally been treated with amphetamine or amphetamine-type drugs. Unfortunately, along with stimulating wakefulness, these products also stimulate the cardiovascular and gastrointestinal tract--producing a variety of undesirable side effects, noted Michael Thorpe, M.D., director of the sleep-wake disorders center at Montefiore Medical Center. In addition, "patients commonly experience irritability and anxiety, which can be quite unpleasant," he said. The effort to develop an agent with fewer adverse effects has finally resulted in the approval of Provigil (modafinil, Cephalon).

The nonamphetamine product, indicated for the treatment of excessive daytime sleepiness associated with narcolepsy, exhibits wake-promoting actions like sympathomimetic agents, including amphetamine and methylphenidate. However, the drug's pharmacological profile differs from that of sympathomimetic amines in that it is not associated with generalized stimulation.

According to the observations of Joyce Walsleben, Ph.D., director of the sleep disorder center at New York University, patients who received modafinil did not experience some of the adverse effects associated with current stimulants, such as "highs or rushes of hyper-alertness, withdrawal effects at the end of the day, or difficulty falling asleep." No clinically significant differences in vital signs, body weight, or ECG recordings were found in patients during clinical trials.

The drug's labeling, however, does state that modafinil--known to cause an increase in extracellular dopamine--produces psychoactive and euphoric effects; alterations in mood, perception, and thinking; and feelings typical of other CNS stimulants. As a result, The U.S. Drug Enforcement Administration has proposed that modafinil be placed into schedule IV of the Controlled Substances Act.

The most frequently reported adverse effects include headache, infection, nausea, nervousness, anxiety, and insomnia. Use of modafinil is not recommended in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia, or clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use. Since the new drug has not been evaluated in individuals with hypertension, psychosis, or those with a recent history of myocardial infarction or unstable angina, it should be used with caution in these patients.

Regarding the efficacy of modafinil, Walsleben reported that her patients "began to realize an increase in wakefulness and others around them noticed an improvement in their performance of daily activities." During clinical trials, both 200 and 400 mg of modafinil demonstrated improvements in objective and subjective measures of daytime sleepiness.



  • The recommended dose of Provigil is 200 mg once daily in the morning. In those with severe hepatic impairment, the dose should be reduced by one-half; consideration of the use of lower doses in elderly patients should also be given. The product is supplied as 100- and 200-mg tablets in bottles of 100.
  • Inform patients that the effectiveness of steroidal contraceptives may be reduced during therapy with Provigil and for one month after its discontinuation.
  • Since Provigil has been designated a pregnancy category C, urge patients to contact their physician if they become pregnant or intend to become pregnant during therapy.
  • Advise patients that it is prudent to avoid alcohol while taking Provigil, since the combination of the two drugs has not been studied.
  • Caution should be used when administering Provigil with monoamine oxidase inhibitors, inducers or inhibitors of cytochrome P-450 isoenzymes, clomipramine, and methylphenidate.
  • Tell patients about Provigil's common side effects, such as headache, infection, nausea, nervousness, anxiety, and insomnia.


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