Modafinil: serious skin reactions and psychiatric symptoms

Prescribing information for Provigil (modafinil) has been updated with information about the risk of serious skin reactions and psychiatric symptoms.

Modafinil is indicated for the symptomatic relief of excessive sleepiness associated with narcolepsy, obstructive sleep apnoea and moderate to severe chronic shift work sleep disorder.

There have been reports of Stevens Johnson Syndrome, erythema multiforme, and toxic epidermal necrolysis with modafinil. Treatment should be discontinued at the first sign of rash and not restarted. Suicidal ideation, hallucinations, delusion, aggression, psychosis, and mania have been reported in association with modafinil. These reactions have occurred mainly, but not exclusively, in patients with a history of psychosis, depression or mania.

Treatment should be discontinued in patients who experience any psychiatric symptoms and should not be restarted. Modafinil should be used with caution in patients with a history of psychosis, depression or mania and patients with a history of alcohol, drug or illicit substance abuse

Further information: MHRA

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