What is the ideal dose of trazodone (Trazodone hydrochloride) for insomnia?

From the Guidelines

The ideal dose of trazodone for sleep is typically 50-150 mg taken before bedtime, as reported in a systematic review 1.

Key Considerations

• The dose range of 50-150 mg is based on a systematic review that found no differences in sleep efficiency or rate of discontinuation due to adverse events between trazodone and placebo in patients diagnosed with chronic insomnia 1.
• However, the review had several limitations, including studies of very short durations of therapy and follow-up of only 1 to 4 weeks.
• The low-quality evidence supporting the efficacy of trazodone was outweighed by its adverse effect profile, leading to a suggestion that clinicians not use trazodone as a treatment for sleep onset or sleep maintenance insomnia in adults 1.

Important Factors to Consider

• Trazodone should be taken with food to reduce side effects like dizziness and nausea.
• Side effects may include morning grogginess, dry mouth, and rarely priapism in men.
• Trazodone should not be combined with other serotonergic medications without medical supervision due to risk of serotonin syndrome.

Clinical Guidance

• Most adults should start with a low dose and increase gradually if needed, under medical supervision.
• The medication typically takes 30-60 minutes to start working, and patients should plan for 7-8 hours of sleep after taking it to avoid morning drowsiness.
• Clinicians should consider alternative treatments for sleep onset and sleep maintenance insomnia, as suggested by the American Academy of Sleep Medicine clinical practice guideline 1.

From the FDA Drug Label

1. 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 ideal dose of trazodone for sleep is not explicitly stated in the drug label. However, it is suggested that drowsiness may require the administration of a major portion of the daily dose at bedtime. The initial dose is suggested to be 150 mg/day in divided doses, and the dosage may be increased by 50 mg/day every 3 to 4 days. Key points to consider:

• Initial dose: 150 mg/day
• Dose increase: 50 mg/day every 3 to 4 days
• Administration: major portion of the daily dose at bedtime if drowsiness occurs 2

From the Research

Ideal Dose of Trazodone for Sleep

• The ideal dose of trazodone for sleep is not explicitly stated in the provided studies, but some studies suggest the following doses:
  • 150 mg given predominantly at bedtime, increased as needed to 200 to 300 mg for full antidepressant efficacy 3
  • The maximum outpatient dose should not exceed 400 mg per day in divided doses, but in hospitalized patients, the dose may be increased to a maximum dose of 600 mg daily in divided doses 4
• It is worth noting that trazodone is often prescribed at lower doses for sleep, and the exact dose may vary depending on the individual patient and their specific needs.

Mechanism of Action

• Trazodone's mechanism of action involves antagonism of the 5-HT2A receptors, H1 receptors, and alpha-1 adrenergic receptors, which contributes to its hypnotic action at lower doses 4
• Trazodone's involvement in the opioid system may also contribute to its use for the induction and maintenance of sleep 5

Clinical Applications

• Trazodone is one of the most commonly prescribed agents used to treat insomnia, particularly in patients who have relative contraindications for sedative-hypnotics 4, 6
• The use of trazodone for sleep is often off-label, and its efficacy and safety for this indication are not as well established as for its approved use in treating major depressive disorder 6