Clinical Question

Is trazodone effective and safe for treating insomnia?

Evidence-Based Answer

Trazodone should not be used to treat insomnia. Trazodone decreases the number of nightly awakenings and may slightly improve subjective sleep quality, but it does not significantly improve total sleep time, sleep efficiency (the ratio of time sleeping to time in bed), sleep latency, or waking time after sleep onset. (Strength of Recommendation [SOR]: B, multiple low-quality studies.) Trazodone causes more adverse effects than placebo. (SOR: B, low-quality randomized controlled trial [RCT].) It also has a higher fall risk than zolpidem or benzodiazepines. (SOR: B, retrospective cohort study.) Patients treated with trazodone, zolpidem, and benzodiazepines have higher fall rates than untreated patients.

Evidence Summary

A 2018 meta-analysis examining the use of trazodone for insomnia included seven RCTs with 429 adults (mean age = 46.1 years; range = 38.2 to 81 years; 58.2% female). Six trials took place in the outpatient setting, and one trial combined inpatients and outpatients.¹ Patients with insomnia were included regardless of whether it was primary or secondary insomnia. Primary outcomes included sleep efficiency and self-reported sleep quality. When trazodone was compared with placebo, there was no significant improvement in sleep efficiency (standardized mean difference [SMD] = 0.09; 95% CI, −0.19 to 0.38; P =.53) and small to no change in sleep quality (SMD = −0.41; 95% CI, −0.82 to −0.00; P =.05). Secondary outcomes included sleep latency, total sleep time, number of awakenings, and waking time after sleep onset. There was a significant decrease in the number of awakenings in patients receiving trazodone compared with placebo (SMD = −0.51; 95% CI, −0.97 to −0.05), with no significant differences in other secondary outcomes.