YAWNS NB (YAWNS-2)
Trial question
What is the role of EMPOWER package in older adults with long-term BZRAs use for insomnia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
64.0% female
36.0% male
N = 374
374 patients (239 female, 135 male).
Inclusion criteria: older adults aged ≥ 65 years with long-term BZRA use for insomnia.
Key exclusion criteria: residential care; use of non-BZRA sedatives for insomnia; score of < 10 on the mini-Montreal Cognitive Assessment for telephone; any health condition potentially associated with BZRA use.
Interventions
N=187 EMPOWER package (mailed booklets titled "You May Be at Risk" and "How to Get a Good Night's Sleep Without Medication").
N=187 treatment as usual (no package).
Primary outcome
Successful benzodiazepine receptor agonist discontinuation at 6 months
34.8%
20.3%
34.8 %
26.1 %
17.4 %
8.7 %
0.0 %
EMPOWER
package
Treatment as
usual
Significant
increase ▲
NNT = 6
Significant increase in successful BZRA discontinuation at 6 months (34.8% vs. 20.3%; AD 14.5%, 95% CI 5.33 to 23.67).
Secondary outcomes
No significant difference in mean improvement in sleep efficiency at 6 months (-1.7% vs. -1.6%; MD -0.1, 95% CI -3.65 to 3.45).
Significantly greater reduction in mean Insomnia Severity Index at 6 months (1.7 points vs. -0.3 points; MD 2, 95% CI 0.81 to 3.19).
No significant difference in mean improvement in 12-Item Short-Form Health Survey Mental Component Score at 6 months (1.1 points vs. -0.6 points; MD 1.6, 95% CI -0.47 to 3.67).
Conclusion
In older adults aged ≥ 65 years with long-term BZRA use for insomnia, EMPOWER package was superior to treatment as usual with respect to successful BZRA discontinuation at 6 months.
Reference
David M Gardner, Justin P Turner, Sandra Magalhaes et al. Patient Self-Guided Interventions to Reduce Sedative Use and Improve Sleep: The YAWNS NB Randomized Clinical Trial. JAMA Psychiatry. 2024 Dec 1;81(12):1187-1197.
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