Product: Nuvigil

Company: Cephalon

Pharmacologic class: Wakefulness promoter

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Active ingredient: Armodafinil 50 mg, 150 mg, 250 mg; tabs.

Indication: To improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy, and shift-work sleep disorder (SWSD). Adjunct to standard treatment for underlying airway obstruction in OSAHS.

Pharmacology: Armodafinil is the R-enantiomer of modafinil (Provigil). Of the two enantiomers that comprise modafinil, the R-form is longer lasting. Both of these drugs have wakefulness- promoting effects similar to those of sympathomimetics such as amphetamines and methylphenidate.

Clinical trials: Two 12-week studies were conducted to establish the safety and efficacy of armodafinil in OSAHS. In the first study, patients were given either armodafinil 150 mg or 250 mg/day, or placebo. The second trial compared the effects of armodafinil 150 mg/day and placebo. Both studies indicated that patients given armodafinil showed improvements in their ability to remain awake and in their overall clinical condition.

The results of a 12-week study indicated that armodafinil was effective in improving wakefulness in patients with excessive sleepiness associated with narcolepsy. Patients treated with armodafinil 150 mg or 250 mg/day showed a significantly enhanced ability to remain awake, and more of the patients given armodafinil had an improved overall clinical condition than those given placebo.

A 12-week trial was conducted to establish the efficacy of armodafinil in patients with chronic SWSD. Patients were randomized to receive either armodafinil 150 mg/day or placebo. Those given the study drug showed a significant prolongation in the time to sleep onset, as measured by a sleep latency test conducted during a simulated night shift at the final visit, compared with those given placebo. Also, more patients treated with armodafinil experienced an improvement in overall clinical condition, compared with patients given the placebo.

Adults: >17 years: OSAHS, narcolepsy: 150 mg or 250 mg once daily in the am. SWSD: 150 mg one hour before starting shift. Severe hepatic impairment: reduce dose.

Children: <17 years: not recommended.

Precautions: Discontinue if rash appears (unless clearly not drug-related), or if angioedema, anaphylaxis, or multi- organ hypersensitivity reaction occurs. OSAHS: treat underlying obstruction; maintain continuous positive airway pressure use if indicated. History of left ventricle hypertrophy or mitral valve prolapse syndrome (e.g., ischemic ECG changes, chest pain, arrhythmias associated with central nervous system [CNS] stimulants): not recommended. Recent MI. Unstable angina. Monitor BP. Psychosis. Depression. Mania. Severe hepatic or renal impairment. Re- evaluate periodically. Elderly (may need to reduce dose). Labor and delivery. Pregnancy (Cat. C). Nursing mothers. Interactions: May antagonize hormonal contraceptives; use alternative or additional contraception during and for one month after. Avoid alcohol. Caution with monoamine oxidase inhibitors. Armodafinil levels may be decreased by CYP3A4 inducers (e.g., carbamazepine, phenobarbital, rifampin) and increased by CYP3A4 inhibitors (e.g., ketoconazole, erythromycin). May reduce levels of drugs metabolized by CYP3A4 (e.g., cyclosporine). May increase levels of drugs metabolized by CYP2C9 (e.g., warfarin) or CYP2C19 (e.g., phenytoin, diazepam, propranolol).

Adverse reactions: Headache, insomnia, other CNS effects, GI upset; rash (may be serious, e.g., Stevens-Johnson, toxic epidermal necrolysis).

How supplied: Tabs—60

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