EMA Releases Updated Guidance on Insomnia Treatments
The European Medicines Agency has updated the guideline on medicinal products for the treatment of insomnia.
The European Medicines Agency has updated the guideline on medicinal products for the treatment of insomnia. The guideline was first adopted in 1991 and the new version reflects the advances in the scientific understanding of insomnia over the past two decades.
Insomnia is a condition where people have difficulty falling or staying asleep. Patients with insomnia often have poor quality of life and difficulty carrying out everyday tasks.
The updated guideline informs companies how they should carry out studies on medicines for insomnia, in order to stand the best chances of gaining marketing authorisation. It focuses on:
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