N/A
N=132
Discontinuation of Hypnotics in Older Veterans
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT03511209 ↗Enrolled (actual)
132
Serious AEs
2.3%
Results posted
Nov 2024
Primary outcome: Primary: Rates of Hypnotic Discontinuation — 48; 36 Participants — p=0.056
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBTI plus taper method A (Behavioral); CBTI plus taper method B (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Hypnotic Discontinuation |
48; 36 | 0.056 |
| PRIMARY Insomnia Severity Index Score |
14.11; 14.20 | 0.405 |
Summary
Sleeping medications, called hypnotics, are often prescribed for insomnia. About one-quarter of Veterans use hypnotics (or bedtime alcohol). Older patients who use hypnotics fall more often and have worse memory than those who do not use them. Stopping hypnotics often reverses these problems. The Department of Veterans Affairs (VA) is trying to reduce hypnotic use among older adults. Currently, there are two main treatments to help patients stop using hypnotics. The first treatment involves a slow decrease in the daily dose until the hypnotic is ultimately discontinued. For safety, the process of decreasing the daily dose is usually supervised by a physician. The second is a treatment for insomnia called cognitive behavioral therapy for insomnia (CBTI).
This study will compare a novel hypnotic tapering method to the usual tapering method offered to older Veterans. The purpose of the study is to determine if the novel tapering method is more effective than the usual tapering method, both in terms of hypnotic discontinuation and improvement in insomnia severity.
Participants will be recruited from among Veterans 55 years and older who receive care from one VA Healthcare System. Following a baseline assessment, participants will be randomly assigned to one of the two 8-week treatment groups (66 participants per group). Each treatment group will receive CBTI, however, one group will receive the novel tapering program and the other group the usual tapering program. Follow-up assessments will be conducted at post-treatment and at 6-months after completion of the treatment.
If the novel tapering program is effective, it will represent a treatment option that can be offered to older Veterans who want to discontinue hypnotics. This tapering program could help VA healthcare providers adhere to clinical guidelines that recommend benzodiazepine discontinuation among older adults. A reduction in chronic hypnotic use may in turn reduce the risk of falls and hip fractures, which ultimately may improve the health and quality of life of older Veterans who receive healthcare at the VA.
Eligibility Criteria
Inclusion Criteria
Age >= 55 years
- Use of lorazepam, alprazolam, temazepam, clonazepam, and/or zolpidem for current or prior insomnia symptoms 2 or more nights per week for at least 3 months
- Current or prior insomnia symptoms
- Available to attend weekly in-person or video sessions over 9 weeks
Exclusion Criteria
High risk for complications in outpatient hypnotic discontinuation program:
- Seizure disorder
- Supratherapeutic/high baseline hypnotic dose (> diazepam-equivalent of 8 mg/night). Note that for individuals on > 1 of the targeted hypnotics, total baseline dose in diazepam-equivalents will be calculated & if > 8 mg/night, individual will be excluded.
- High risk of complicated withdrawal; benzodiazepine intoxication or current or past symptoms of complicated benzodiazepine/alcohol withdrawal (e.g., seizure, delirium at baseline)
- Polydrug use (e.g., chronic high dose opioids)
- Unable to keep study medications in secure location
- Evidence of prescription fraud (e.g., multiple prescriptions for same drug filled at VA and non-VA pharmacies, diversion)
Discontinuation of hypnotic not appropriate:
- Study-targeted hypnotic used to treat another clinical condition (e.g., Rapid Eye Movement sleep behavior disorder)
- Not willing to begin hypnotic discontinuation program
Poor candidate for CBTI:
- Presence of bipolar disorder
- Cognitive impairment (e.g., Mini-Mental State Examination 30 AHI between 15 and 30 and daytime sleepiness (Epworth Sleepiness Scale > 10)
- Medically/psychiatrically unstable (e.g., recent major hospitalization or planned major surgery during the study; psychosis, suicidal, active alcohol/substance abuse based on history and medical records)
- Unstable housing situation
Data sourced from ClinicalTrials.gov (NCT03511209). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.