MODAFINIL APPROVED IN FRANCE

2 November 1992

Despite fears of misuse, the French regulatory authorities have granted marketing approval to Laboratoires L Lafon for modafinil, the so-called "anti-sleep pill" publicized during the Gulf war, where it was tested on French military personnel.

Modafinil, a member of the adrafanil group of compounds, will have relatively limited indications once launched, namely narcolepsy and idiopathic hypersomnia. The fear of misuse of the compound has led to its inclusion in the context of new legislation covering the prescription of certain drugs.

Under this legislation, modafinil will be included in the List I category (formerly Schedule A), and while prescribable by physicians working in office practice and hospital doctors, prescriptions must be made out using a dangerous substances pad. Nevertheless, the prescriptions will remain renewable on a monthly basis for a maximum of one year.

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