To improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD). History of LV hypertrophy or mitral valve prolapse syndrome (eg, ischemic ECG changes, chest pain, arrhythmias associated with CNS stimulants): not recommended. Tabs-60 Facts about narcolepsy * Narcolepsy is a chronic neurologic disorder caused by the brain's inability to regulate sleep-wake cycles normally. * The disorder is characterized by four major symptoms: Excessive daytime sleepiness (EDS); cataplexy, or the sudden loss of voluntary muscle tone; hallucinations during sleep onset or upon awakening; and short episodes of total paralysis at the beginning or end of sleep.
drug0909.qxd 8/25/09 9:14 AM Page 14 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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