Medicinal products for the treatment of insomnia

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/16274/2009 Rev. 1
Published25/02/2011
Effective from01/09/2011
KeywordsInsomnia, primary insomnia, secondary insomnia, diagnostic criteria, co-morbidity, special populations, polysomnography, treatment options, short-term efficacy, long-term maintenance
DescriptionThis document provides guidance on the development of medicinal products for acute and long-term treatment of insomnia. It focuses mailny on primary insomnia, but covers alco some issues on secondary or co-morbid insomnia.


Document history

Revision 1 

Current version

Adopted guideline


Overview of comments


Draft guideline


Concept paper

In operation: 01/09/2011–present


Published: 02/03/2011


Published: 11/11/2009


Published: 19/07/2007

First versionAdopted guidelineIn operation: 01/03/1993–31/08/2011


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