SWITCH (insomnia)
Trial question
What is the role of masked taper of BZRA plus CBT-augmented program in patients with current or prior insomnia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 188
188 patients (65 female, 123 male).
Inclusion criteria: adult patients aged ≥ 55 years who had used lorazepam, alprazolam, clonazepam, temazepam, and/or zolpidem for current or prior insomnia, at doses of < 8 mg diazepam-equivalent ≥ 2 nights/week for at least 3 months.
Key exclusion criteria: high risk for withdrawal complications; poor candidate for CBT-I; discontinuation of BZRA inappropriate; unstable housing.
Interventions
N=92 masked taper (masked taper plus augmented CBT-I).
N=96 supervised gradual taper (unmasked gradual taper CBT-I).
Primary outcome
Successful benzodiazepine receptor agonist discontinuation at 6 months
73.4%
58.6%
73.4 %
55.1 %
36.7 %
18.4 %
0.0 %
Masked
taper
Supervised gradual
taper
Significant
increase ▲
NNT = 6
Significant increase in successful BZRA discontinuation at 6 months (73.4% vs. 58.6%; OR 1.95, 95% CI 1.03 to 3.7).
Secondary outcomes
Significant increase in the rate of successful BZRA discontinuation 1 week after treatment (88.4% vs. 67.4%; HR 3.68, 95% CI 1.67 to 8.12).
No significant difference in Insomnia Severity Index score at 6 months (-6.41 points vs. -6.57 points; AD 0.16 points, 95% CI -1.89 to 2.2).
No significant difference in Insomnia Severity Index score 1 week after treatment (-6.43 points vs. -7.81 points; AD 1.38 points, 95% CI -0.52 to 3.29).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients aged ≥ 55 years who had used lorazepam, alprazolam, clonazepam, temazepam, and/or zolpidem for current or prior insomnia, at doses of < 8 mg diazepam-equivalent ≥ 2 nights/week for at least 3 months, masked taper was superior to supervised gradual taper with respect to successful BZRA discontinuation at 6 months.
Reference
Constance H Fung, Cathy Alessi, Jennifer L Martin et al. Masked Taper With Behavioral Intervention for Discontinuation of Benzodiazepine Receptor Agonists: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1448-1456.
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