Sleep-HD (trazodone)
Trial question
What is role of trazodone in patients undergoing hemodialysis with mild or moderate chronic insomnia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 83
83 patients (41 female, 42 male).
Inclusion criteria: patients undergoing hemodialysis with Insomnia Severity Index score ≥ 10, with sleep disturbances on ≥ 3 nights/week for ≥ 3 months.
Key exclusion criteria: severe cognitive impairment; severe depressive symptoms; suicidal ideation; alcohol or substance misuse; severe restless legs syndrome; pregnancy/lactation; anticipated life expectancy < 3 months.
Interventions
N=42 trazodone (at a starting dose of 50 mg nightly, titrated to 100 mg, for 6 weeks).
N=41 placebo (matching placebo for 6 weeks).
Primary outcome
Reduction in Insomnia Severity Index score at week 7
4.2 points
3.1 points
4.2 points
3.2 points
2.1 points
1.1 points
0.0 points
Trazodone
Placebo
Borderline significant
increase ▲
Borderline significantly greater reduction in Insomnia Severity Index score at week 7 (4.2 points vs. 3.1 points; AD 1.08 points, 95% CI -1.34 to 3.49).
Secondary outcomes
Borderline significantly lower reduction in Insomnia Severity Index score at week 25 (4 points vs. 4.3 points; AD -0.34 points, 95% CI -3.17 to 2.49).
No significant difference in reduction in Pittsburgh Sleep Quality Index at week 7 (0.9 vs. -0.4; AD 1.3 , 95% CI -0.15 to 2.74).
No significant difference in reduction in Epworth Sleepiness Scale at week 7 (0.3 points vs. 1.3 points; AD -0.96 points, 96% CI -2.68 to 0.75).
Safety outcomes
No significant difference in non-serious adverse events.
Conclusion
In patients undergoing hemodialysis with Insomnia Severity Index score ≥ 10, with sleep disturbances on ≥ 3 nights/week for ≥ 3 months, trazodone was not superior to placebo with respect to reduction in Insomnia Severity Index score at week 7.
Reference
Rajnish Mehrotra, Daniel Cukor, Susan M McCurry et al. Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial. Ann Intern Med. 2024 Feb;177(2):177-188.
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