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The Agency's Committee for Medicinal Products for Human Use CHMP has concluded that the benefits of modafinil-containing medicines continue to outweigh their risks but that their use should be restricted to the treatment of narcolepsy. Modafinil is used to promote wakefulness help people stay awake. Modafinil-containing medicines are used in patients who suffer from excessive sleepiness. Excessive sleepiness can be caused by narcolepsy, a disease that causes the person to fall asleep during the day, or it can be due to disturbed night-time sleeping patterns leading to daytime sleepiness. This can be seen in people who work a shift-pattern or in those who suffer from https://www.icliniq.com obstructive sleep apnoea a condition in which pauses in breathing occur repeatedly during the night, disturbing sleep. Excessive sleepiness can also happen with no known causes idiopathic hypersomnia. Medicines containing modafinil were first marketed in Europe in Once the PhVWP had received and started its assessment of the data, the working party had further concerns about the medicines, and consequently, on 14 May, the UK medicines regulatory agency asked the CHMP to carry out a full assessment of the benefit-risk balance of modafinil-containing medicines, and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the European Union. A group of experts on clinical neurosciences was also convened to provide advice.
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Modafinil is used internationally to treat residual sleepiness despite continuous positive airway pressure in obstructive sleep apnoea res-OSA. In, the European Medicines Agency removed the indication based on an unfavourable risk—benefit profile in two trials for efficacy and all accumulated safety data. We analysed 10 of the articles identified that met inclusion criteria patients. Modafinil and armodafinil improve subjective and objective daytime sleepiness in res-OSA. We believe our analysis is a fairer analysis of the risk—benefit profile of this indication.
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