- the types of patients to include in studies;
- how to design insomnia studies, ideally by comparing the medicine with placebo under double-blind, randomised conditions;
- how to assess the safety of medicines for insomnia, including the absence of tolerance or dependence;
- including children and the elderly in studies of anti-insomnia medicines.
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 was adopted by the Committee for Medicinal 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 This document remains in force until September 2011 when it will be superseded by the new guideline.