Usual Adult Dose for Narcolepsy

150 to 250 mg orally once a day in the morning

Comments:

• In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day.
• This drug is not a treatment for the underlying obstruction in OSA.
• In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome

150 to 250 mg orally once a day in the morning

Comments:

• In obstructive sleep apnea (OSA), doses up to 250 mg/day have been well-tolerated but there is no consistent evidence of additional benefit beyond the 150 mg/day.
• This drug is not a treatment for the underlying obstruction in OSA.
• In cases where continuous positive airway pressure (CPAP) is the treatment of choice for excessive sleepiness, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating this drug.

Usual Adult Dose for Shift Work Sleep Disorder

150 mg orally once a day approximately 1 hour prior to the start of the work shift

Use: To improve wakefulness in patients with excessive sleepiness associated with shift work disorder.

Renal Dose Adjustments

No adjustment recommended; use with caution as data is limited

Liver Dose Adjustments

Mild to moderate hepatic impairment: No adjustment recommended
Severe hepatic impairment: A reduced dose is recommended; however, no specific guidelines have been suggested in the manufacturer product information. Use with caution.

Dose Adjustments

Elderly: Lower doses and close monitoring are recommended

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to armodafinil, modafinil, or any product excipients

Dialysis

Data not available

Other Comments

Administration Advice:

• Take orally with or without food

• Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers.
• This drug has not been studied in combination with alcohol and patients should be advised to avoid alcohol while taking this drug.

• Cardiovascular: Heart rate, blood pressure
• Dermatologic: Closely monitor for skin reactions such as rash, mouth sores, blister, or peeling skin
• Psychiatric: Monitor for depression, anxiety, mania, psychosis

• Patients should be instructed to read the US FDA-approved patient labeling (Medication Guide).
• Women should speak to their healthcare provider about alternative birth control options if they are using a hormonal birth control method such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs); effective contraception during use and for 1-month following treatment is recommended; for patients who become pregnant during treatment, a pregnancy registry is available for this drug.
• Avoid driving and doing activities such as operating machinery while taking this drug until your degree of sleepiness/wakefulness has been assessed by your healthcare provider.
• Patients should avoid drinking alcohol while taking this drug.
• Patients should be advised to speak with their healthcare provider immediately if they experience a rash or any allergic reaction, depression, anxiety, or signs of psychosis or mania.
• This drug has the potential to be abused and cause dependence; tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.