NUVIGIL

What it is

NUVIGIL is a medicine containing armodafinil, available in tablets of 50, 150 or 250 mg. The tablets contain lactose monohydrate.

Approved indications NUVIGIL 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

To avoid a delayed onset of action NUVIGIL should be taken on an empty stomach.

Key safety warnings

Serious rash requiring hospitalisation and discontinuation of treatment has been reported in association with the use of NUVIGIL, including rare cases of Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms. There are no known factors to predict the risk or severity of rash, and serious rash may occur from 1 day to 2 months after starting treatment. NUVIGIL should be discontinued at the first sign of rash, unless the rash is clearly not drug-related. Angioedema and hypersensitivity reactions with rash, dysphagia, and bronchospasm have been observed with NUVIGIL. Patients should discontinue therapy and immediately report to their physician any signs or symptoms suggesting angioedema or anaphylaxis, including swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; or hoarseness. Multi-organ hypersensitivity reactions, including fatal cases, have occurred in close temporal association with initiating modafinil, and similarly a single fatal case of Drug Rash with Eosinophilia and Systemic Symptoms was reported with NUVIGIL, though such reactions may result in hospitalisation or be life-threatening. In clinical trials, anxiety, agitation, nervousness, and irritability were reasons for treatment discontinuation more often in patients on NUVIGIL compared to placebo, as was depression. Caution should be exercised when NUVIGIL is given to patients with a history of psychosis, depression, or mania, and if psychiatric symptoms develop in association with NUVIGIL administration, consider discontinuing NUVIGIL. NUVIGIL has not been evaluated in patients with a recent history of myocardial infarction or unstable angina and such patients should be treated with caution; it is recommended that NUVIGIL not be used in patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced mitral valve prolapse syndrome when previously receiving CNS stimulants.

Contraindications

NUVIGIL is contraindicated in patients with hypersensitivity to modafinil, armodafinil or any other component of the product. Armodafinil is contraindicated in pregnancy.

PBS listing

NUVIGIL is listed on the PBS in three strengths: 50 mg, 150 mg, and 250 mg tablets. Each strength has one PBS item and requires authority required restriction. The ex-manufacturer prices are A$41.90 for the 50 mg tablet, A$125.69 for the 150 mg tablet, and A$209.48 for the 250 mg tablet.

Regulatory history

NUVIGIL armodafinil 250 mg and 150 mg tablet blister packs were first listed on the ARTG on 26 November 2015, with the 50 mg strength added on 28 April 2016.