Usual Adult Dose for Narcolepsy

200 mg orally once a day in the morning

Comments:

• In obstructive sleep apnea (OSA), this drug is not a treatment for the underlying obstruction.
• If 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 and during treatment with this drug.

Usual Adult Dose for Obstructive Sleep Apnea/Hypopnea Syndrome

200 mg orally once a day in the morning

Comments:

• In obstructive sleep apnea (OSA), this drug is not a treatment for the underlying obstruction.
• If 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 and during treatment with this drug.

Usual Adult Dose for Shift Work Sleep Disorder

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

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

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

• Mild to moderate hepatic impairment: There are no dosage adjustments provided in the manufacturer product information.
• Severe hepatic impairment: Dose should be reduced by half.

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule IV

Dialysis

Data not available

Other Comments

Administration Advice:

• This drug can be taken with or without food.
• Drug tablets should be swallowed whole.

• This drug should be stored at 20 to 25 degrees Celsius (68 to 77 Fahrenheit).

• This drug opposes the impairment of cognitive (in particular, memory), psychomotor, and neurosensory performance induced by sleep deprivation in the absence of any appetite or behavior modifications.
• This drug is a 1:1 racemic compound (90% R-isomer and 10% S-isomer at steady state), whose enantiomers have different pharmacokinetics and do not interconvert.
• Although this drug has wake-promoting actions akin to sympathomimetic agents (e.g., amphetamine and methylphenidate), it is dissimilar to amphetamine in that its effects are not antagonized by haloperidol and the locomotor activity it induces are not blocked by alpha-methyl-p-tyrosine.
• Modafinil-induced wakefulness can be attenuated by prazosin; however, modafinil is inactive in other assay systems known to be responsive to alpha-adrenergic agonists (e.g., rat vas deferens preparation).
• There is no specific antidote for overdosage; induced emesis or gastric lavage should be considered and surveillance of psychomotor status and cardiovascular monitoring is recommended.

• Patient monitoring and clinical assessment of treatment need should be performed on a periodic basis as the long-term efficacy (more than 9 weeks) of this drug has not been evaluated.
• Cardiovascular: Heart rate, blood pressure, general cardiovascular status
• General: Degree of sleepiness/drowsiness; signs of misuse or abuse
• Immunologic: Signs and symptoms of angioedema/anaphylaxis
• Psychiatric: Development of de novo or exacerbation of pre-existing psychiatric disorders (every dose adjustment and regularly during treatment)

• Women who use hormonal birth control methods may have a higher chance of getting pregnant while taking this drug and for 1 month after stopping treatment. Talk to your healthcare provider about alternative birth control options if you use a hormonal birth control method such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs).
• Avoid driving and other potentially dangerous activities such as operating machinery during treatment until you know how this drug affects you.
• Avoid drinking alcohol while taking this drug.
• This drug may help with sleepiness, but it is not a replacement for getting enough sleep; maintain good sleep hygiene including reviewing your caffeine intake with your healthcare provider.

Frequently asked questions

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