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Enhancing Hypnotic Medication Discontinuation in Primary Care

Enhancing Hypnotic Medication Discontinuation in Primary Care Through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy

Who can join

Ages 21 and older · All sexes

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.

About the study

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 randomized trial comparing a combined digital CBT (dCBTI) and medication tapering intervention with medication tapering alone. We'll recruit 430 patients reliant on hypnotics from 8-10 primary care clinics affiliated with the University of Colorado Medical School. The main goal is to assess the effectiveness of dCBTI+SMT compared to SMT alone in reducing hypnotic use and improving insomnia symptoms.

Additionally, we'll evaluate factors affecting the adoption and implementation of these interventions at the patient, provider, and system levels. This information will inform future implementation strategies to disseminate effective treatments in primary care.

Furthermore, we'll gather data to identify which patients benefit most from dCBTI+SMT. Overall, this study will provide valuable insights into the feasibility, clinical utility, and acceptability of these interventions in managing insomnia and reducing reliance on hypnotic medications in primary care. Ultimately, this project represents a crucial first step toward making accessible and cost-effective strategies available to improve the quality of life for millions of chronic users of sleep aids.

What is being tested

• Digital Cognitive Behavioral Therapy (behavioral)
• Structured Medication Tapering (behavioral)

Sponsor: National Jewish Health · Participants: 430 · Started: Jan 1, 2025

Contact the study team

• RJ Johnson, MA · Phone: 303-398-1058

Official record on ClinicalTrials.gov — NCT06435520

Locations in the U.S.

Conditions

• Insomnia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.