About this trial
Among older adults (≥65 years), use of sleeping pills, such as benzodiazepines and other sedative-hypnotics, to treat sleep problems is common. While sleeping pills are effective in the first few weeks of use, their effect diminishes significantly after that. Especially older adults are susceptible to significant adverse effects of sleep pills, yet stopping sleeping pills remains challenging. BE-SAFE aims to conduct a randomised study testing a patient-centred intervention to reduce sleeping pill use and to improve patient safety and quality of care focusing on implementation aspects. The intervention addresses knowledge and practice gaps related to discontinuation of sleeping pills in older adults with sleep problems.
Eligibility criteria
Qualifiers
≥65 years old
BSH (ATC codes N05BA, N05CF, N05CD, and N03AE01) use on average ≥3 times a week during the last 3 months prior to providing informed consent, as self-reported by the patient or by the informal carer
Taking BSH for sleep problems, as self-reported by the patient or by the informal carer
Disqualifiers
Current use of BSH for alcohol withdrawal
BSH use in the context of addiction
Rapid Eye Movement (REM) sleep Behaviour Disorders
Active diagnosis of severe non-REM-related parasomnias with risk of self-damage or giving harm to others or with high frequency or social embarrassment
Trial design
Treatments tested in this trial
- Specific tapering plan for sleep medication, educational and cognitive behavioural therapy elements
Treatment groups
Sponsors and collaborators
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Universitat Autonoma de Barcelona
Collaborator
Oslo University Hospital
Collaborator
National and Kapodistrian University of Athens
Collaborator
Institute of Psychiatry and Neurology, Warsaw
Collaborator
CHU UCL Namur
Collaborator
Université Catholique de Louvain
Collaborator