EMA 失眠治疗指南2016.pdf

《EMA 失眠治疗指南2016》.pdf7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +4 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail ******@ Website .eu An agency of the European Union ? European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. 17 February 2011 EMA/CHMP/16274/2009 previously (EMEA/16274/2009) Rev. 1 Committee for medicinal products for human use (CHMP) Guideline on medicinal products for the treatment of insomnia Date of first Adoption September 1991 Date of entry into force March 1992 Revised draft Agreed by EWP September 2009 Adoption by CHMP for release for consultation 22 October 2009 End of consultation (deadline ments) 30 April 2010 Agreed SWP October 2010 Adoption by CHMP 17 February 2011 Date ing into effect September 2011 This guideline replaces NfG “Clinical Investigation of Hypnotic Medicinal Products (3CC27a from March 1992). Reference. 1 Keywords Insomnia, primary insomnia, secondar y insomnia, diagnostic criteria, co-morbidity, special populations, po lysomnography, treatment options, short-term efficacy, long-term maintenance. 2 NfG “Clinical Investigation of Hypnotic Medicinal Products (3CC27a from March 1992). Guideline on medicinal products for the treatment of insomnia Table of contents Executive summary ..................................................................................... 3 1. Introduction (backgro und)...................................................................... 3 2. Scope....................................................................................................... 4 3. Legal basis .............................................................................................. 5 4. Diagnostic criteria ................................................................................... 5 . Diagnosis of Primary Insomnia............................................................................. 5 .