Annals of Internal MedicineEffectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis

A Randomized Clinical Trial

This study delves into the effectiveness of cognitive behavioral therapy for insomnia (CBT-I), trazodone, and placebo in treating chronic insomnia among patients undergoing long-term hemodialysis. Chronic insomnia is a prevalent issue in this patient group, with limited evidence supporting effective treatment methods.

Study Design:

• Participants: Patients undergoing in-center hemodialysis with an Insomnia Severity Index (ISI) score ≥10, experiencing sleep disturbances ≥3 nights per week for ≥3 months.
• Locations: 26 dialysis units across Albuquerque, New Mexico, and Seattle, Washington.
• Intervention: Randomized assignment to 6 weeks of CBT-I, trazodone, or placebo.
• Measurement: Primary outcome measured by ISI score changes at 7 and 25 weeks post-randomization.

Key Findings:

• ISI Score Changes: No significant difference in ISI score changes from baseline at 7 weeks among CBT-I, trazodone, or placebo groups.
• Long-term Outcomes: Similar lack of significant difference in ISI scores from baseline at 25 weeks.
• Adverse Events: Higher incidence of serious adverse events, particularly cardiovascular, noted in the trazodone group.

HCN Medical Memo
In this study, neither cognitive behavioral therapy for insomnia (CBT-I) nor trazodone showed superiority over placebo in effectiveness over a 6-week period. Additionally, trazodone was associated with a higher incidence of serious adverse events compared to the other treatments.

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