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                                 New Drug Information
                                                 F R O M T H E E D I T O R S O F T H E PA P R



      PRODUCT: Nuvigil                             proved overall clinical condition than       additional contraception during and for
      COMPANY: Cephalon                            those given placebo.                         1 month after. Avoid alcohol. Caution
      PHARMACOLOGIC CLASS: Wakefulness                A 12-week trial was conducted to          with MAOIs. Armodafinil levels may
      promoter                                     establish the efficacy of armodafinil in     be decreased by CYP3A4 inducers
      ACTIVE INGREDIENTS: Armodafinil              patients with chronic SWSD. Patients         (eg, carbamazepine, phenobarbital,
      50mg, 150mg, 250mg; tabs.                    were randomized to receive either            rifampin) and increased by CYP3A4
                                                   armodafinil 150mg/day or placebo.            inhibitors (eg, ketoconazole, eryth-
      INDICATION: To improve wakeful-              Those given the study drug showed a          romycin). May reduce levels of drugs
      ness in patients with excessive sleepi-      significant prolongation in the time to      metabolized by CYP3A4 (eg, cyclo-
      ness associated with obstructive sleep       sleep onset, as measured by a sleep          sporine). May increase levels of drugs
      apnea/hypopnea syndrome (OSAHS),             latency test conducted during a simu-        metabolized by CYP2C9 (eg, warfarin)
      narcolepsy and shift work sleep disor-       lated night shift at the final visit, com-   or CYP2C19 (eg, phenytoin, diazepam,
      der (SWSD). Adjunct to standard              pared to those given placebo. Also,          propranolol).
      treatment for underlying airway              more patients treated with armodafinil
      obstruction in OSAHS.                        experienced an improvement in overall        ADVERSE REACTIONS: Headache,
                                                   clinical condition, compared to patients     insomnia, other CNS effects, GI upset;
      PHARMACOLOGY: Armodafinil is the             given the placebo.                           rash (may be serious, eg, Stevens-
      R-enantiomer of modafinil (Provigil).                                                     Johnson, toxic epidermal necrolysis).
      Of the two enantiomers that comprise         ADULTS: ≥17 years: OSAHS, narcolep-
      modafinil, the R-form is longer lasting.     sy: 150mg or 250mg once daily in the         HOW SUPPLIED: Tabs—60
      Both of these drugs have wakefulness-        AM. SWSD: 150mg one hour before
      promoting effects similar to those of        starting shift. Severe hepatic impair-
      sympathomimetics such as ampheta-            ment: reduce dose.
                                                                                                 Facts about narcolepsy
      mines and methylphenidate.
                                                   CHILDREN: <17 years: not recom-               • Narcolepsy is a chronic neurologic
      CLINICAL TRIALS: Two 12-week                 mended.                                       disorder caused by the brain’s inability
                                                                                                 to regulate sleep-wake cycles normally.
      studies were conducted to establish
      the safety and efficacy of armodafinil    
								
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