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Restrictions on use of modafinil for sleep disorders recommended in EU

 
• By Malini Guha

The EU's CHMP has recommended restricting the use of modafinil-containing medicines to the treatment of sleepiness associated with narcolepsy because of concerns over safety that are already largely reflected in product labelling - including neuropsychiatric disorders and skin and subcutaneous tissue reactions - which it said did not outweigh its benefits in other approved indications.

The EU's CHMP has recommended restricting the use of modafinil-containing medicines to the treatment of sleepiness associated with narcolepsy because of concerns over safety that are already largely reflected in product labelling - including neuropsychiatric disorders and skin and subcutaneous tissue reactions - which it said did not outweigh its benefits in other approved indications.

Medicines containing modafinil, a wakefulness promoting agent that is thought to interact with neurotransmitters in the brain such as dopamine...

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