Intended and unintended effects of Z-drug use for sleep disturbance in people with dementia – ‘Z-drug Evaluation in Dementia’ (ZED)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18007
• EU PAS number:
  EUPAS18006
• Study ID:
  18007
• Official title and acronym:
  Intended and unintended effects of Z-drug use for sleep disturbance in people with dementia – ‘Z-drug Evaluation in Dementia’ (ZED)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Sleep disturbance is common in dementia, and can severely affect patient and carer quality of life. Z-drugs (zolpidem, zaleplon and zopiclone) are sedating hypnotics that are used for insomnia in older people and in people with dementia. Current guidance suggests Z-drugs or short acting benzodiazepines (BZD) can relive sleep disturbance and can provide respite for carers. Nevertheless there are concerns about tolerance, addiction and the safety of Z-drugs, with adverse effects including increases in falls and fracture risk, impaired daytime cognition, and higher risks of infections. Other sedating neuroleptics are known to increase stroke risk and mortality, with mediating pathways including dehydration and over-sedation and it is important to confirm whether Z-drugs confer similar risks.Our aim is to understand the benefits and harms of using Z-drugs for people with dementia who have trouble sleeping. Using data from the Clinical Practice Research Datalink we will look at whether people with dementia who take Z-drugs fall more often, have more infections or are taken to hospital more often among other health outcomes. We will compare Z-drugs to other sleep drugs prescribed to people with dementia, and to people who do not use any sleep medication at all.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of East Anglia

Study timelines

Date when funding contract was signed

Actual: 23/02/2016

Study start date

Actual: 01/06/2016

Data analysis start date

Planned: 01/06/2017

Date of final study report

Planned: 01/12/2017

Sources of funding

Other

More details on funding

National Institute for Health Research, University of East Anglia

Study protocol

Initial protocol

CPRD ISAC_ZED_R1_180117

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable