MODAVIGIL

What it is

MODAVIGIL contains modafinil 100 mg per tablet. It is a white, round, biconvex tablet. The tablets contain lactose monohydrate and sulfites as excipients with known effect.

Approved indications MODAVIGIL is indicated for the following uses:

— 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

Dosing varies by indication. For narcolepsy and obstructive sleep apnoea/hypopnoea syndrome, the dose is 200 to 400 mg per day, given as a single dose in the morning or as two divided doses in the morning and at noon. For moderate to severe chronic shift work sleep disorder, the recommended daily dose is 200 mg, taken as a single dose approximately 1 hour prior to the start of the work shift. 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, and consideration should be given to the use of lower doses in this population.

Key safety warnings

Serious rash, including Stevens-Johnson syndrome, has been reported in association with modafinil use. Nearly all cases of serious rash occurred within 1 to 5 weeks after treatment initiation. MODAVIGIL should ordinarily be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Discontinuation of treatment may not prevent a rash from becoming life-threatening or permanently disabling or disfiguring. Multi-organ hypersensitivity reactions have occurred in close temporal association to the initiation of modafinil and may result in hospitalization or be life-threatening. Patients typically present with fever and rash associated with other organ system involvement, with other manifestations including myocarditis, hepatitis, liver function test abnormalities, and haematological abnormalities. Psychiatric adverse experiences have been reported in patients treated with modafinil in clinical trials and from post-marketing experience. Patients should be monitored for the development of de novo 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 in patients treated with modafinil, and patients should be carefully monitored for the appearance or worsening of aggressive or hostile behaviour. Suicidal ideation and suicide-related behaviour have been reported in patients treated with modafinil, and patients should be carefully monitored for the appearance or worsening of suicidal thinking and/or 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 with modafinil.

Contraindications

MODAVIGIL is contraindicated in patients with hypersensitivity to modafinil or any other component of the product. Modafinil is contraindicated in pregnancy.

Regulatory history

MODAVIGIL (modafinil 100 mg tablet) was first listed on the Australian Register of Therapeutic Goods on 21 May 2010.