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Published on 2 March 2011

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EMA updates guidance on insomnia medication


The EMA has updated guidance on medicines for insomnia.

The updated guideline, which was first adopted in 1991, reflects advances in the scientific understanding of insomnia over the past two decades.

The updated guideline informs companies how they should carry out studies on medicines for insomnia, to stand the best chance of gaining marketing authorisation.

It focuses on the types of patients to study and the advantages of a placebo-controlled, double-blind, randomized study design.

The guidance also outlines how to assess safety, including medication intolerance and dependence, with recognition of the importance of including children and the elderly in such trials.

People with insomnia have difficulty falling or staying asleep, which can result in a poor quality of life and difficulty carrying out everyday tasks.

The updated guideline was adopted by the Committee of Medicineal Products for Human Use (CHMP) on 17 February 2011, following a public consultation between October 2009 and April 2010. It will come into effect in September 2011.

The guideline was originally adopted by the Committee for Proprietary Medicinal Products (CPMP) of the European Commission in September 1991, before the foundation of the European Medicines Agency.

It was first published as a note for guidance on the ‘clinical investigation of hypnotic medicinal products’. This document remains in force until September 2011 when it will be superseded by the new guideline.

European Medicines Agency 2011


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