From the Guidelines
Trazodone should not be used as a first-line treatment for insomnia due to its adverse effect profile and limited efficacy, as evidenced by a 2020 systematic review published in the Annals of Internal Medicine 1. The recommended approach for managing insomnia prioritizes non-pharmacological interventions and behavioral therapies. When pharmacologic agents are considered, the lowest effective dose and shortest possible duration should be used, with careful counseling on potential risks. In the context of trazodone, a dose range of 50 to 150 mg before bedtime has been studied, but its efficacy in improving sleep efficiency or reducing discontinuation due to adverse events was not significantly different from placebo 1. Key considerations for clinicians include:
- The potential for adverse effects, such as morning drowsiness, dizziness, and dry mouth, which may outweigh any benefits of trazodone for insomnia treatment.
- The lack of high-quality evidence supporting the long-term use of trazodone for insomnia, with most studies having short durations of therapy and follow-up.
- Alternative treatment options, such as cognitive-behavioral therapy for insomnia (CBT-I), which have been shown to be effective and safer in the long term. Given the current evidence, the use of trazodone for insomnia should be approached with caution, and alternative treatments should be considered first 1.
From the FDA Drug Label
- Dosage and Administration 2. 1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage.
The recommended dosage of Trazodone for the treatment of insomnia is not explicitly stated in the drug label. However, it is mentioned that drowsiness may require the administration of a major portion of the daily dose at bedtime. The initial dose suggested is 150 mg/day in divided doses, but the label does not provide a specific dosage for insomnia. 2
From the Research
Trazodone Dosage for Insomnia
- The recommended dosage of Trazodone for the treatment of insomnia is not strictly established, but studies suggest that a low dose is effective 3, 4, 5.
- A study published in 1990 recommends a dose of 150 mg given predominantly at bedtime, increased as needed to 200 to 300 mg for full antidepressant efficacy 6.
- Another study published in 2008 suggests that the dose should be as low as possible, with an initial dose of 50 mg 4.
- A study published in 2007 used a dose of 25-150 mg/d, with significant improvement in sleep quality and daytime functioning 5.
- A review published in 2017 suggests that low-dose trazodone is effective for the treatment of insomnia, with a dose-dependent side effect profile, and the most common side effect being drowsiness 3.
Factors Influencing Dosage
- The dosage of Trazodone may depend on the presence of concomitant depressive symptomology or a history of depression 4.
- The dosage may also depend on the specific indication, such as primary insomnia or insomnia in the course of affective disorders 7.
- The study published in 2021 suggests that trazodone is less effective than hypnotics in the treatment of sleep onset insomnia, but very effective in the treatment of sleep-maintenance insomnia, especially in patients with comorbid mental disorders or patients treated with activating antidepressants 7.
Comparison with Other Treatments
- Trazodone has been compared to hypnotics in the treatment of insomnia, with studies suggesting that trazodone increases the duration of deep sleep, while hypnotics decrease slow-wave activity in sleep EEG 7.
- The main mechanism through which trazodone promotes sleep is its antagonistic effect on 5-HT2 serotonin receptors, while hypnotics are agonists of gamma-aminobutyric acid GABAA receptors, and other sedative antidepressants block H1 histamine receptors 7.