Modafinil’s indications restricted
Modafinil (Provigil) has had its licensed indications restricted and can now only be used to treat excessive sleepiness in adult patients with narcolepsy.
The drug is no longer licensed for treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome and moderate to severe chronic shift work sleep disorder.
The move follows an assessment by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which has concluded that the benefit/risk profile for modafinil is no longer favourable for these conditions.
Cephalon (UK) Ltd, the company that markets Provigil, has written to healthcare professionals in the UK advising them of the change.
In its letter the company explains that safety concerns, including psychiatric and serious skin reactions and the potential for cardiovascular adverse effects are now considered to outweigh the limited benefits of modafinil in obstructive sleep apnoea and chronic shift work sleep disorder.
As well as restricting modafinil’s indications, the CHMP has concluded that it should not be used by children, pregnant or lactating women or by patients with uncontrolled hypertension or cardiac arrhythmias. It also recommends that the starting daily dose is 200mg and that the drug is used with caution in patients with a history of psychosis, depression or mania, or substance abuse.
Cephalon says there is no need for patients to stop treatment immediately but that they should have their treatment reviewed at their next routine appointment.
Citation: The Pharmaceutical Journal URI: 11069293
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