Armodafinil

NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating NUVIGIL for excessive sleepiness.

The mechanism(s) through which armodafinil promotes wakefulness is unknown. Armodafinil (R-modafinil) has pharmacological properties similar to those of modafinil (a mixture of R- and S-modafinil), to the extent tested in animal and in vitro studies. The R- and S-enantiomers have similar pharmacological actions in animals. Armodafinil and modafinil have wake-promoting actions similar to sympathomimetic agents including amphetamine and methylphenidate, although their pharmacologic profile is not identical to that of the sympathomimetic amines. Modafinil-induced wakefulness can be attenuated by the α1-adrenergic receptor antagonist, prazosin, however, modafinil is inactive in other in vitro assay systems known to be responsive to α-adrenergic agonists such as the rat vas deferens preparation.

The recommended dosage of NUVIGIL for each indication is as follows: OSA or Narcolepsy: 150 mg to 250 mg once a day in the morning. SWD: 150 mg once a day, taken approximately one hour prior to start of the work shift. Hepatic Impairment: reduced dose in patients with severe hepatic impairment. Geriatric Patients: consider lower dose.

NUVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients. NUVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil.

Serious Rash, including Stevens-Johnson Syndrome: discontinue NUVIGIL at the first sign of rash, unless the rash is clearly not drug-related. DRESS/Multi-organ Hypersensitivity Reactions: if suspected, discontinue NUVIGIL. Angioedema and Anaphylaxis Reactions: if suspected, discontinue NUVIGIL. Persistent Sleepiness: assess patients frequently for degree of sleepiness and, if appropriate, advise patients to avoid driving or engaging in any other potentially dangerous activity. Psychiatric Symptoms: use particular caution in treating patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop. Known Cardiovascular Disease: consider increased monitoring.

The following serious adverse reactions are described below and elsewhere in the labeling: Serious Dermatologic Reactions Drug Reaction with Eosinophilia and System Symptoms (DRESS)/Multiorgan Hypersensitivity Angioedema and Anaphylaxis Reactions Persistent Sleepiness Psychiatric Symptoms Effects on Ability to Drive and Use Machinery Cardiovascular Events Most common adverse reactions (≥5%): headache, nausea, dizziness, and insomnia.

Effects of NUVIGIL on CYP3A4/5 Substrates The clearance of drugs that are substrates for CYP3A4/5 (e.g., steroidal contraceptives, cyclosporine, midazolam, and triazolam) may be increased by NUVIGIL via induction of metabolic enzymes, which results in lower systemic exposure. Dosage adjustment of these drugs should be considered when these drugs are used concomitantly with NUVIGIL. The effectiveness of steroidal contraceptives may be reduced when used with NUVIGIL and for one month after discontinuation of therapy. Alternative or concomitant methods of contraception are recommended for patients taking steroidal contraceptives (e.g., ethinyl estradiol) when treated concomitantly with NUVIGIL and for one month after discontinuation of NUVIGIL treatment. Blood levels of cyclosporine may be reduced when used with NUVIGIL.

Storage Store at 20 o C - 25 o C (68 o F - 77 o F).