Armodafinil is indicated to improve wakefulness in adult patients with:

• Obstructive sleep apnea (OSA)
• Narcolepsy
• Shift work sleep disorder (SWD)

Armodafinil is the R-enantiomer of modafinil and acts as an indirect dopamine receptor agonist. It binds to the dopamine transporter and inhibits dopamine reuptake, resulting in increased extracellular dopamine levels. This enhances neuronal activity, particularly in the hypothalamus, including the tuberomammillary nucleus (TMN), which plays a key role in regulating wakefulness and the sleep-wake cycle.

Adults:

• Obstructive Sleep Apnea & Narcolepsy: 150 mg to 250 mg as a single dose in the morning.
• Shift Work Disorder: 150 mg as a single dose approximately 1 hour prior to the start of work shift.

Children: Safety and effectiveness in pediatric patients less than 17 years of age have not been established.

Elderly: In elderly patients, elimination of Armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses and close monitoring in this population.

Armodafinil may increase the clearance of drugs metabolized by CYP3A4/3A5 (e.g., steroidal contraceptives, cyclosporine, midazolam, triazolam), potentially reducing their effectiveness. Dose adjustment of these medications may be required.

It may also inhibit CYP2C19, leading to increased blood levels of drugs such as phenytoin, diazepam, propranolol, omeprazole, and clomipramine; therefore, dose modification should be considered.

When used with warfarin, closer monitoring of prothrombin time/INR is recommended. Caution is advised when co-administering with monoamine oxidase (MAO) inhibitors.

Armodafinil is contraindicated in patients with known hypersensitivity to Armodafinil or any component of the formulation.

Serious adverse effects may include severe skin reactions (such as Stevens-Johnson syndrome), angioedema, anaphylaxis, multi-organ hypersensitivity reactions, persistent sleepiness, psychiatric symptoms, and cardiovascular events.

There are no adequate and well-controlled studies of Armodafinil in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Armodafinil is excreted in human breast milk; caution is advised during breastfeeding.

Patients should avoid operating vehicles or heavy machinery until they know how Armodafinil affects them. Use cautiously in patients with a history of psychiatric disorders such as psychosis, depression, or mania. Discontinue treatment if psychiatric symptoms occur. Regular monitoring of heart rate and blood pressure is recommended. Use with caution in patients with cardiovascular disease.

Hepatic impairment: Dose reduction is recommended in severe hepatic dysfunction

Renal impairment: Insufficient data are available regarding safety and dosing in severe renal impairment

No specific antidote is available. Symptoms of overdose may include agitation, insomnia, and mild to moderate increases in heart rate and blood pressure. Management is supportive.

Central nervous system (CNS) stimulant.

Store below 25°C, protected from light and moisture. Keep out of reach of children.