YAWNS NB (YAWNS-1)
Trial question
What is the role of sleepwell package in older adults with long-term BZRA use for insomnia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
62.0% female
38.0% male
N = 378
378 patients (235 female, 143 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=191 sleepwell package (mailed booklets titled "How to Stop Sleeping Pills" and "How to Get Your Sleep Back").
N=187 treatment as usual (no package).
Primary outcome
Successful benzodiazepine receptor agonist discontinuation at 6 months
46.6%
20.3%
46.6 %
35.0 %
23.3 %
11.7 %
0.0 %
Sleepwell
package
Treatment as
usual
Significant
increase ▲
NNT = 3
Significant increase in successful BZRA discontinuation at 6 months (46.6% vs. 20.3%; AD 26.3%, 95% CI 10.69 to 41.91).
Secondary outcomes
Significantly greater improvement in mean sleep efficiency at 6 months (4.1% vs. -1.6%; MD 5.7, 95% CI 2.09 to 9.31).
Significantly greater reduction in mean Insomnia Severity Index at 6 months (2 points vs. -0.3 points; MD 2.3, 95% CI 0.94 to 3.66).
No significant difference in mean improvement in 12-Item Short-Form Health Survey Mental Component Score at 6 months (0.7 points vs. -0.6 points; MD 1.2, 95% CI -0.88 to 3.28).
Conclusion
In older adults aged ≥ 65 years with long-term BZRA use for insomnia, sleepwell 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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