From the Guidelines
Trazodone is not recommended for the treatment of chronic insomnia disorder due to its low-quality evidence supporting efficacy and significant adverse effect profile. The most recent and highest quality study, published in 2020 in the Annals of Internal Medicine 1, reported that the work group advised against the use of trazodone for treatment of chronic insomnia disorder. This recommendation was based on 4 fair-quality systematic reviews that evaluated the use of pharmacologic agents, including trazodone. Although trazodone was more effective at improving subjective sleep quality, there were no differences in sleep onset latency, total sleep time, or wake after sleep onset compared to placebo 1.
The evidence suggests that the benefits of trazodone for insomnia treatment are outweighed by its potential harms, including risk for dependency, falls, and cognitive impairment in older patients, hypoventilation in patients with respiratory conditions, and neuromuscular diseases 1. Additionally, a systematic review reported no differences in sleep efficiency or rate of discontinuation due to adverse events between trazodone and placebo in patients diagnosed with chronic insomnia 1.
Instead of trazodone, cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for adults with chronic insomnia disorder, as it has been shown to improve global outcomes, including increased remission and treatment response, and reduced insomnia severity index and Pittsburgh Sleep Quality Index scores compared to controls 1. If pharmacological therapy is considered, it should be used in conjunction with CBT-I and with a shared decision-making approach, including a discussion of the benefits, harms, and costs of short-term use of medications 1.
Key points to consider when treating insomnia include:
- CBT-I as the first-line treatment
- Avoiding the use of trazodone and other sedating medications due to their potential harms
- Practicing good sleep hygiene, including maintaining a regular sleep schedule, avoiding screens before bedtime, and creating a comfortable sleep environment
- Using pharmacological therapy with caution and in conjunction with CBT-I, if necessary.
From the Research
Efficacy of Trazodone for Treating Insomnia
- Trazodone has been shown to be efficacious for sleep maintenance difficulties, with studies demonstrating its ability to reduce night-time awakenings and improve sleep quality 2, 3, 4.
- The medication has been found to be particularly effective in treating sleep-maintenance insomnia, especially in patients with comorbid mental disorders or those being treated with activating antidepressants 4.
- Trazodone has also been shown to increase the duration of deep sleep, which is associated with better sleep quality as assessed by patients 4, 5.
- When combined with cognitive behavior therapy (CBT), trazodone has been found to be effective in the short-term management of chronic primary insomnia, with significant improvements in sleep latency, sleep efficiency, and total sleep time 5.
Comparison with Hypnotics
- Trazodone has been compared to hypnotics in the treatment of insomnia, with studies suggesting that it is less effective than hypnotics in treating sleep onset insomnia, but more effective in treating sleep-maintenance insomnia 4.
- Unlike hypnotics, trazodone increases the duration of deep sleep, which is associated with better sleep quality 4.
Clinical Evidence
- A systematic review of 45 studies found evidence to support the efficacy and safety of low-dose trazodone for the treatment of insomnia 3.
- Another study found that trazodone was effective in treating insomnia in patients with major depressive disorder, with significant improvements in sleep quality and depressive symptoms 6.
- The medication has been found to be well-tolerated, with the most common side effect being drowsiness, which is dose-dependent 3, 4.