Improving Patient Safety by Supporting Older Adults in Managing Sleep Problems.

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.

NCT Number	NCT06584513
Lead Sponsor	Insel Gruppe AG, University Hospital Bern Collaborators: Universitat Autonoma de Barcelona, Oslo University Hospital, National and Kapodistrian University of Athens, Institute of Psychiatry and Neurology, Warsaw, Centre Hospitalier Universitaire UCLouvain Namur, Université Catholique de Louvain
Conditions	Benzodiazepines Deprescribing, Sleep Problems
Enrollment	470 participants
Start Date	2024-11-18
Primary Completion	2027-07-31 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-03