From the Guidelines
Trazodone is not recommended for the treatment of insomnia due to its adverse effect profile and lack of efficacy in improving sleep outcomes, as suggested by the American Academy of Sleep Medicine clinical practice guideline 1. The guideline recommends against using trazodone as a treatment for sleep onset or sleep maintenance insomnia in adults, based on trials of 50 mg doses of trazodone 1.
- The medication has been found to have a low-quality evidence supporting its efficacy, which is outweighed by its adverse effect profile 1.
- Trazodone has sedating properties at lower doses than those used for its primary indication of depression, but its use for insomnia is not supported by strong evidence.
- Patients should be aware of potential side effects including morning drowsiness, dizziness, dry mouth, and rarely priapism in men.
- Alternative treatments, such as cognitive behavioral therapy for insomnia (CBT-I) or other pharmacologic agents, may be considered for the management of insomnia.
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 dose of trazodone for insomnia is not explicitly stated in the label, but it can be inferred that drowsiness is a consideration for dosing, and a major portion of the daily dose may be administered at bedtime. However, the label does not provide a specific dose for insomnia. 2
From the Research
Trazodone Dosage for Insomnia
- The ideal dose of trazodone for insomnia is not explicitly stated in the provided studies, but earlier studies (1980-2000) focused on utilizing trazodone at high doses (≥100mg/d) for the treatment of insomnia among the depressed population 3.
- Since the 2000s, the utility of trazodone has been expanded to treat secondary insomnia among the non-depressed population as well, with a focus on low-dose use 3.
- The side effects of trazodone are dose-dependent, and the most common is drowsiness 3, 4.
- A review of the literature suggests that there are adequate data supporting the efficacy and general safety of the low-dose use of trazodone for the treatment of insomnia 3.
Efficacy and Safety of Trazodone for Insomnia
- Trazodone has been investigated in a number of disorders besides depression and insomnia, including anxiety disorders, chronic pain, frontal cognitive dysfunctions, erectile dysfunction, and others 4.
- Clinical studies using subjective and objective measures generally tend to support its efficacy as a hypnotic in depressed subjects 4.
- Trazodone extends total sleep time but does not affect perceived sleep duration, and it may improve sleep quality and continuity but has minor effects on sleep latency, efficiency, and daytime impairment 5.
- Trazodone is associated with adverse effects, necessitating a careful risk-benefit assessment 5.
Long-Term Trazodone Use and Cognition
- Long-term use of trazodone, an SWS enhancer, is associated with delayed cognitive decline, adding support for a potentially attractive and cost-effective intervention in dementia 6.
- The observed effects were especially associated with subjective improvement of sleep complaints in post-hoc analyses 6.