Inpharma 1667 - 6 Dec 2008

Modafinil gets a reaction inAustralia; ten, actually

The Australian Adverse Drug Reactions Bulletin haslooked into reports of reactions to modafinil, in the wakeof recent international attention regarding the drug,particularly related to skin and psychiatric reactions.

Modafinil is a CNS stimulant used for the treatment ofpatients with excessive daytime sleepiness due tonarcolepsy or chronic shift work sleep disorder, and alsoas an adjunct treatment for sleep apnoea syndrome. Ithas ben available for use in Australia since July 2002, andto September 2008, more than 4000 prescriptions havebeen issued.

Since 2003, ten adverse events associated withmodafinil have been reported, including two skinreactions, and five psychiatric reactions. The skinreactions were an erythematous rash and an urticarialrash, respectively.* In both instances, ceasing the drugsled to resolution of the reactions and rechallenged led torecurrence, including a more severe reaction in onecase.

The five patients with psychiatric reactions presentedwith anxiety, abnormal behaviours, guilt, rapid onset ofdepression, suicidal ideation and behaviour, orpsychosis; all five patients had a history of psychiatricdisorders. Symptoms resolved after termination of themodafinil therapy in all patients, with recurrence ofdepression with one rechallenge.

It was advised that "at the first sign of rash, or ifpatients experience psychiatric symptoms, modafinilshould be discontinued and not restarted".* The details of these cases appear in this issue: see

Modafinil: adverse skin and psychiatric reactions. Australian Adverse DrugReactions Bulletin 27: 22, No. 6, Dec 2008 801075426

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Inpharma 6 Dec 2008 No. 16671173-8324/10/1667-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved