New program aims to help seniors kick the sleeping pill habit
NCT ID NCT06584513
First seen Jun 25, 2026 · Last updated Aug 04, 2026 · Updated 3 times
Summary
This study tests a patient-centred program to help older adults (65+) reduce or stop using sleeping pills like benzodiazepines. The program includes a tapering plan, educational materials, and cognitive behavioural therapy tools. Researchers will track whether participants can cut back safely and improve their sleep quality.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- behavioural intervention (tapering plan, educational materials, cognitive behavioural therapy elements)
- What this could lead to
- If successful, this could provide a safe, effective way for older adults to stop relying on sleeping pills, reducing fall risks and other side effects.
- What could go wrong
- This is a relatively small implementation study, not a large-scale trial. The intervention may not work for everyone, and some people may need to continue medication.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 470 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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65 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥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 Exclusion Criteria: * Indication for BSH appropriate or withdrawal dangerous, based on available documents (diagnosis list) or General Practitioner (GP) information: * 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 * Epilepsy (all forms, because of risk of seizures by sleep deprivation) * Current active diagnosis of severe general or specific anxiety disorder (including obsessive compulsive disorder, social phobia, post-traumatic stress disorder, panic disorder with or without agoraphobia) * Current active diagnosis of psychotic disorder with or without antipsychotic medication * Current active diagnosis of severe depression with or without major anxiety symptoms * Current active diagnosis of bipolar disorder with or without major anxiety symptoms * Acute suicidal ideation * Current formal active tapering process of BSHs supported by a physician * Planned admission to palliative care within 24 hours of inclusion or estimated life-expectancy of less than 12 months i.e., patient is in a state or has a diagnosis where the cluster physician would not be surprised if patient dies within the next months (this criterion is relatively vague and subjective but because there is no validated prognostic score, it is justified) * Inability to provide informed consent (e.g., because of cognitive impairment), except if a proxy can provide consent, be actively involved in the study, and patient shows no sign of disagreement
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier Universitaire CHU UCL Namur
Yvoir, 5530, Belgium
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Department of General Internal Medicine, University Hospital Bern (Inselspital)
Bern, 3010, Switzerland
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Institute of Psychiatry and Neurology
Warsaw, 02-957, Poland
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National and Kapodistrian University of Athens
Athens, 10679, Greece
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Oslo University Hospital
Nydalen, 4950, Norway
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Universitat Autònoma de Barcelona
Barcelona, 08041, Spain
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