Effectiveness of Z-drug hypnotics in the treatment of adult insomnia compared with placebo using US Food and Drug Administration (FDA) data

Project title	Effectiveness of Z-drug hypnotics in the treatment of adult insomnia compared with placebo using US Food and Drug Administration (FDA) data
Funding body	College of Social Science Research Fund
Total funding	£1,500
Team	Professor A. Niroshan Siriwardena, Professor of Primary and Prehospital Healthcare, Community and Health Research Unit, University of Lincoln. Jo Middlemass, Research Fellow, Community and Health Research Unit, University of Lincoln. Dr Markos Klonizakis, Research Fellow, Community and Health Research Unit, University of Lincoln. Tania Huedo-Medina, Associate Professor, Department of Allied Health Sciences, University of Connecticut, 358 Mansfield Road U-2101, Storrs, CT 06269-2101, USA Professor Irving Kirsch, Harvard Medical School, Beth Israel Deaconess Medical Center, USA.
Overarching aim	To examine the effectiveness of Z-drug hypnotic drugs.
Objectives	To perform a meta-analysis review of the evidence for clinical effectiveness of Z-drug hypnotics for insomnia which includes data from the FDA provided for the approval of drugs and which may include both published and unpublished data and to provide recommendations for areas of primary research based primarily on the meta-analysis.
Methods	Data were obtained on all clinical trials submitted to the US Food and Drug Administration (FDA) for the licensing of the three newer hypnotic Z-drugs– zopiclone, eszopiclone, zaleplon and zolpidem. We will analyse efficacy of the drugs across the baseline score on the particular efficacy indicator. We will determine for each meta-analysis the weighted mean of the effect sizes.
Outcomes	The study has been completed and published.
Outputs	Peer reviewed publications Our research paper in the BMJ has had over 140 citations since its publication in 2012. Huedo-Medina T, Kirsch I, Middlemass J, Klonizakis M, Siriwardena AN. Effectiveness of non-benzodiazepine hypnotics in treatment of adult insomnia: meta-analysis of data submitted to the Food and Drug Administration. British Medical Journal 2012; 345: e8343 doi: 10.1136/bmj.e8343 Conference presentations Siriwardena AN, Huedo-Medina TB, Middlemass J, Klonzakis M, Kirsch I. How effective are Z-drug hypnotics for treatment of adult insomnia? Meta-analysis of data submitted to the Food and Drug Administration. SAPC 41st Annual Scientific Meeting, 3-4 October 2012, Glasgow, UK.
Impact	The study had worldwide media coverage and has informed research and clinical decisions about use of hypnotic drugs. The impact from this study and our research on insomnia and hypnotic drugs is summarised at the REST project website, was presented in a case study to REF2014, Improving the primary care management of insomnia, and publicised in the university research showcase, ‘Improving treatment for insomnia sufferers‘.

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