Armodafinil | Nuvigil
NUVIGIL is indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). (1)
Limitations of Use: In OSA, NUVIGIL is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction.
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. (2.1)
- SWD: 150 mg once a day, taken approximately one hour prior to start of the work shift. (2.2)
- Hepatic Impairment: reduced dose in patients with severe hepatic impairment. (2.3, 12.3)
- Geriatric Patients: consider lower dose. (2.4, 12.3)
Dosage Forms and Strengths: Tablets: 50 mg, 150 mg, 200 mg, and 250 mg.
Armodafinil | Nuvigil Prescribing Information Highlights
The following points are shortened, highlighted information from prescribing information for this drug. For the full prescribing information PDF, click the button below to be directed to the FDA PDF label for this drug.
—–INDICATIONS AND USAGE—–
- See description above.
—–DOSAGE AND ADMINISTRATION—–
- See description above.
- NUVIGIL is contraindicated in patients with known hypersensitivity to modafinil or armodafinil.
—–WARNINGS & PRECAUTIONS—–
- Serious Rash, including Stevens-Johnson Syndrome: discontinue NUVIGIL at the first sign of rash, unless the rash is clearly not drugrelated. (5.1)
- Angioedema and Anaphylaxis Reactions: if suspected, discontinue NUVIGIL. (5.2)
- Multi-organ Hypersensitivity Reactions: if suspected, discontinue NUVIGIL. (5.3)
- 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. (5.4)
- Psychiatric Symptoms: use particular caution in treating patients with a history of psychosis, depression, or mania. Consider discontinuing NUVIGIL if psychiatric symptoms develop. (5.5)
- Known Cardiovascular Disease: consider increased monitoring. (5.7)
- Most common adverse reactions (>5%): headache, nausea, dizziness, and insomnia. (6.1)
- Steroidal contraceptives (e.g., ethinyl estradiol): use alternative or concomitant methods of contraception while taking NUVIGIL and for one month after discontinuation of NUVIGIL treatment. (7)
- Cyclosporine: blood concentrations of cyclosporine may be reduced. (7)
- CYP2C19 substrates, such as omeprazole, phenytoin, and diazepam: exposure of these medications may be increased.(7)