Z-drugs for sleep disturbance in people with dementia.

 
   Lead Investigator:    Eduwin Pakpahan
   Institution      :    University of East Anglia
   E-Mail           :    e.pakpahan@uea.ac.uk
   Proposal ID      :    828



   Proposal Description:
   to estimate the benefits and harms of using Z-drugs (zolpidem, zopiclone or       zaleplon henceforth Zs) for people with dementia (PwD) by using data from         primary care and existing clinical research studies.                              Our aim is to estimate the benefits and harms of Z-drugs among people with        dementia.                                                                          We are pursuing a traditional pharmacoepidemiological approach to assessing      the risk of adverse drug reaction but this will not yield information on          patient or carer reported outcomes, function or cognitive decline.                Existing clinical trials of dementia are likely to include data on these          outcomes, the exposure.  Individual studies may not include sufficient            participants and so collections of studies such as the ADCS could potentially     be a useful source of information.                                                The studies we are interesting in using are those that include an adequate        assessment of the inclusion criteria for our analysis (presence and severity of   sleep disorders, often included in the Neuropsychiatric Inventory) our exposure   of interest (Z-drugs), and one or more of our outcome measures (cognitive         function, patient and carer quality of life, behavioural and psychological        symptoms, daily function, falls and fractures) and with sufficient numbers of     individuals recruited and follow-up assessments.                                  Our initial analysis will be conducted to establish the feasibility of the        study by describing the numbers of people with documented sleep disorders and     taking Z-drugs with suitable follow-up and outcome measures. Variables of         interest include sociodemographic characteristics of participants, details of     medications being used at baseline and follow-up assessments, detail of sleep     disorders and outcomes as descri