MODAFINIL

What it is

MODAFINIL is a wakefulness-promoting agent for oral administration. MODAFINIL tablets contain 100 mg of modafinil.

Approved indications MODAFINIL is indicated:

— to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy — to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where nonpharmacological interventions are unsuccessful or inappropriate — as an adjunct to continuous positive airways pressure (CPAP) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness

Dosing overview

In patients with severe hepatic impairment, the dose should be reduced to one-half of that recommended for patients with normal hepatic function. In elderly patients, elimination of modafinil and its metabolites may be reduced as a consequence of aging; therefore, consideration should be given to the use of lower doses in this population.

Key safety warnings

Serious rash requiring hospitalisation and discontinuation of treatment has been reported in association with modafinil use, including rare cases of Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms in post-marketing experience. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation. Modafinil should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Multi-organ hypersensitivity reactions have occurred in close temporal association to the initiation of modafinil and may result in hospitalisation or be life-threatening. Patients typically presented with fever and rash associated with other organ system involvement, with manifestations including myocarditis, hepatitis, liver function test abnormalities, and haematological abnormalities. Psychiatric adverse experiences have been reported in patients treated with modafinil; patients should be monitored for the development of new psychiatric disorders or exacerbation of pre-existing psychiatric disorders at every adjustment of dose and regularly during treatment. The onset or worsening of aggressive or hostile behaviour has been reported; patients should be carefully monitored for the appearance or worsening of aggressive or hostile behaviour. Suicidal ideation and suicide-related behaviour have been reported; patients should be carefully monitored for the appearance or worsening of suicidal thinking and suicide-related behaviour. In hypertensive patients, blood pressure should be adequately controlled before initiating treatment with modafinil and monitored regularly during treatment; blood pressure, heart rate and general cardiovascular status should be monitored in all patients during treatment. It is recommended that modafinil not be used in patients with a history of left ventricular hypertrophy or ischaemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with CNS stimulant use. Based on human experience, modafinil is suspected to cause congenital malformations and spontaneous abortion when administered during pregnancy.

Contraindications

Hypersensitivity to modafinil or any other component of the product. Modafinil is contraindicated in pregnancy.

Regulatory history

MODAFINIL was first approved on 20 November 2015.