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Enhancing Hypnotic Medication Discontinuation in Primary Care

RecruitingPhase 4Ages 21 Years - anyAllNational Jewish Health
NCT06435520 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Many individuals with insomnia seek treatment in primary care settings, where they often receive prescription hypnotic medications as their first and sometimes only treatment. However, extended use of these medications can lead to reliance and increased health risks, such as falls and cognitive impairments. While evidence-based approaches like physician-supervised medication tapering exist, they're not widely available in primary care. Most primary care providers are willing to explore non-drug treatments like cognitive behavioral therapy for insomnia (CBTI), but accessing such treatments can be challenging outside of specialized sleep centers. This gap between research and practice underscores the need for cost-effective interventions to manage insomnia and help patients reduce their reliance on hypnotics in primary care. In response to this need, the project aims to conduct a large r

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📋 Eligibility rules (as published)
Inclusion Criteria: * a history of extended (\> 6 consecutive months) and frequent (\>5 nights/week on average) use of benzodiazepine (BZD) or non-BZD hypnotic medications; * a desire to decrease/eliminate hypnotic use; * a history of insomnia that meets DSM-560 criteria for insomnia disorder; and * willingness to provide written informed consent to participate. Exclusion Criteria: * a lifetime diagnosis of any psychotic disorder, suicide attempts, or bipolar disorder; * presence of an unstable, untreated, or terminal major medical or psychiatric disorder; * alcohol or drug abuse within the past year; * current use of a BZD for another disorder in addition to insomnia (e.g., seizure disorder, restless leg syndrome, anxiety disorder); * pregnancy; * significant cognitive impairment as suggested by a score of ≤ 24 on the Folstein Mini-Mental State Examination (MMSE); * current use of medications known to cause insomnia (e.g., high dose corticosteroids); * untreated comorbid sleep disorders; * use of a sedating antidepressant or antipsychotic medication solely for sleep; and * consuming \>2 alcoholic beverages/day ≥5 times/week or any use of marijuana ≥5 times/week.
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What it tests

  • Digital Cognitive Behavioral Therapy
  • Structured Medication Tapering
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Where

1 site
National Jewish Health
Denver, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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