Medicinal products for the treatment of insomnia - Scientific guideline

This 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.

Keywords: Insomnia, primary insomnia, secondary insomnia, diagnostic criteria, co-morbidity, special populations, polysomnography, treatment options, short-term efficacy, long-term maintenance

Current effective version

Guideline on medicinal products for the treatment of insomnia - Revision 1

Adopted Reference Number: EMA/CHMP/16274/2009 Rev.1

Document history - Revision 1 (current)

Guideline on medicinal products for the treatment of insomnia - Revision 1

Adopted Reference Number: EMA/CHMP/16274/2009 Rev.1

Overview of comments received on the draft guideline on medicinal products for the treatment of insomnia

Reference Number: EMA/607700/2010

Draft guideline on medicinal products for the treatment of insomnia

Draft: consultation closed Consultation dates: 22/10/2009 to 30/04/2010 Reference Number: EMEA/16274/2009

Concept paper on the need for revision of the guideline on clinical investigation of hypnotic medicinal products

Reference Number: EMEA/CHMP/EWP/310566/2007

Document history - First version

Clinical Investigation of Hypnotic Medicinal Products

Adopted Reference Number: 3CC27a Legal effective date: 01/03/1992