What is the recommended dose of trazodone (antidepressant) for sleep aid?

From the Guidelines

Trazodone is not recommended for the treatment of sleep onset or sleep maintenance insomnia in adults, according to the most recent and highest quality study 1. The American Academy of Sleep Medicine clinical practice guideline suggests that clinicians not use trazodone as a treatment for sleep onset or sleep maintenance insomnia in adults, based on trials of 50 mg doses of trazodone 1. However, in real-life clinical practice, if trazodone is to be used off-label for insomnia, the dose typically ranges from 25 to 100 mg taken orally at bedtime, with most patients starting with a low dose of 25-50 mg and adjusting as needed based on response and side effects. Some key points to consider when using trazodone for sleep aid include:

• The medication should be taken 30-60 minutes before bedtime for optimal effect
• Patients may experience side effects including morning drowsiness, dizziness, dry mouth, and rarely priapism (prolonged erection) in men
• The medication should be used under medical supervision, and the lowest effective dose should be employed to minimize side effects
• Patients should avoid alcohol and other CNS depressants while taking trazodone, as these combinations can increase sedation to dangerous levels, as noted in the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense clinical practice guidelines 1. It's also important to note that trazodone is not FDA-approved specifically for sleep disorders, and its use for this purpose is off-label. Given the potential risks and side effects associated with trazodone, as well as the lack of strong evidence supporting its efficacy for insomnia, the use of trazodone for sleep aid should be approached with caution and carefully considered on a case-by-case basis, with a focus on minimizing harm and optimizing patient outcomes 1.

From the FDA Drug Label

The dosage should be initiated at a low level 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. Usual Adult Dosage An initial dose of 150 mg/day in divided doses is suggested The dose may be increased by 50 mg/day every three to four days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses.

The recommended dose of trazodone for sleep aid is not explicitly stated in the label, but it can be inferred that a low dose is typically used, often administered at bedtime due to the occurrence of drowsiness. The usual adult dosage starts at 150 mg/day, which may be increased by 50 mg/day every three to four days. However, the label does not provide a specific dose for sleep aid, and the dosage is generally tailored to the individual's response and tolerance 2.

• Key points:
  • Initial dose: 150 mg/day
  • Dose increase: 50 mg/day every three to four days
  • Maximum dose for outpatients: 400 mg/day
  • Dose at bedtime may be considered due to drowsiness.

From the Research

Trazodone Dosage for Sleep Aid

The recommended dose of trazodone for sleep aid varies, but several studies provide insight into its efficacy and safety:

• A study from 1990 3 suggests that trazodone is best dosed at 150 mg given predominantly at bedtime and increased as needed to 200 to 300 mg for full antidepressant efficacy.
• A 2011 study 4 used a dose of 50 mg of trazodone 30 minutes before bedtime for 7 days in primary insomniacs, showing improvements in sleep maintenance difficulties.
• A dose-finding study from 1999 5 found that trazodone at a dosage of 50-100 mg/day improved sleep disorders, particularly at the 100 mg/day dosage, when administered in a single dose before bedtime.
• Another study from 1984 6 compared single night-time and divided daily dosage regimens of trazodone (100-400 mg daily) and found equivalent therapeutic efficacy for the two dosage regimens, with tolerance being good in both groups.

Key Findings

• Trazodone has been shown to be effective in improving sleep in patients with major depression and primary insomniacs 3, 4, 5.
• The most common side effect of trazodone is sedation, which can be beneficial for sleep aid 3.
• Studies suggest that a single dose of trazodone at bedtime may be more effective for sleep aid than divided daily doses 3, 6.
• The optimal dose of trazodone for sleep aid may vary depending on the individual patient and their specific needs 3, 4, 5, 6.

Comparison with Other Sleep Aids

• A 2023 study 7 compared the treatment outcomes of patients initiated on melatonin and trazodone for new-onset insomnia in non-ICU hospitalized patients, finding no significant difference between the two agents in terms of the primary outcome.