CBT-I, Trazodone Ineffective at Improving Insomnia for Patients on Hemodialysis

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Investigators observed no change in Insomnia Severity Index scores from baseline to weeks 7 and 25 with CBT-1, trazodone, or placebo, suggesting these insomnia treatment options are not effective for patients undergoing hemodialysis.

Cognitive behavioral therapy for insomnia (CBT-I) and trazodone are not effective insomnia treatments for patients undergoing hemodialysis, according to a new study. When patients underwent 6 weeks of cognitive behavioral therapy or trazodone to treat mild or moderate chronic insomnia, the team found the treatments did not perform better than placebo.

The investigators, led by Rajnish Mehrotra, MD, MS, from the Kidney Research Institute, the Division of Nephrology, Department of Medicine, at the University of Washington School of Medicine in Seattle, Washington, aimed to compare the effectiveness of CBT-I, trazodone, and placebo for insomnia in patients undergoing long-term hemodialysis. Despite individuals undergoing hemodialysis often having chronic insomnia, limited evidence exists on effective treatments.

According to the Mayo Clinic, CBT-I is the first treatment recommended for insomnia. The treatment can help individuals understand what thoughts and behaviors lead to their sleep problems and how to replace the thoughts and behaviors with healthy sleep habits. A sleep specialist may recommend a patient to change their routine, set sleep limits, change lifestyle habits, improve sleep area, learn relaxation techniques, try not to think about falling asleep, and use biofeedback, such as a device to show signs of heart rate and muscle tension.

Individuals can also turn to pharmacological mediums for improving sleep. Additionally, prior research has demonstrated trazodone, an antidepressant, may be effective for improving insomnia when administered in low doses ranging from 25 to 100 mg.1,2

To understand the effectiveness of CBT-I and trazodone for insomnia in patients undergoing hemodialysis, Mehrotra and colleagues conducted a randomized, multicenter, double-blinded, placebo-controlled trial in 26 dialysis units in Albuquerque, New Mexico, and Seattle, Washington. ​​For inclusion, participants were required to have an Insomnia Severity Index (ISI) score of ≥ 10 with sleep disturbances on ≥ 3 nights per week for ≥ 3 months. After screening 928 for chronic insomnia, 411 patients were randomized to 6 weeks of CBT-1 (n = 43), trazodone (n = 42), or placebo (n = 41).

The primary outcome was the change in ISI score at weeks 7 and 25 to assess score differences from baseline. The investigators observed no difference in change in ISI scores from baseline to 7 weeks with CBT-I (difference, -3.7; 95% confidence interval [CI], −5.5 to −1.9), trazodone (−4.2; 95% CI, −5.9 to −2.4), placebo (−3.1; 95% CI, −4.9 to −1.3). From baseline to 25 weeks, the team observed no significant changes in ISI scores with CBT-I, trazodone, and placebo.

When assessing safety outcomes, the team observed more frequent serious adverse events, specifically serious cardiovascular events, with trazodone (annualized cardiovascular serious adverse event incidence rate, 0.64; 95% CI, 0.34 – 1.10) than CBT-I (0.05; 95% CI, 0.00 – 0.29) and placebo (0.21; 95% CI, 0.06 – 0.53).

The investigators highlighted multiple limitations, including the “modest sample size” of 411 individuals and most participants having mild or moderate insomnia. Thus, individuals with severe insomnia were not represented as much in the trial and could be studied more in future research.

“In patients undergoing hemodialysis with mild or moderate chronic insomnia, there was no difference in the effectiveness of 6 weeks of CBT-I or trazodone compared with placebo,” investigators concluded. “The incidence of SAEs was higher with trazodone.”


  1. Mehrotra R, Cukor D, McCurry SM, et al. Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis: A Randomized Clinical Trial. Ann Intern Med. Published online January 16, 2024. doi:10.7326/M23-1794
  2. Insomnia Treatment: Cognitive Behavioral Therapy Instead of Sleeping Pills. Mayo Clinic. Accessed January 17, 2024.
  3. McAdoo, S. Trazodone for Sleep: What to Know About This Antidepressant’s Common Off-Label Use. GoodRx Health. May 15, 2023. Accessed January 17, 2024.