What is the recommended dose and frequency of Trazodone (triazolopyridine antidepressant) for treating insomnia?

From the Guidelines

Trazodone is not recommended for the treatment of chronic insomnia disorder due to its adverse effect profile outweighing its benefits, as stated in the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense clinical practice guidelines 1. The guidelines advise against the use of trazodone for treating chronic insomnia disorder, citing 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. 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 1. The review had several limitations, including studies of very short durations of therapy and follow-up of only 1 to 4 weeks, and the low-quality evidence supporting the efficacy of trazodone was outweighed by its adverse effect profile 1.

Some key points to consider when evaluating the use of trazodone for insomnia include:

• The dose range of trazodone for insomnia is typically 50 to 150 mg before bedtime, but the evidence supporting its efficacy is low-quality and outweighed by its adverse effects 1.
• Trazodone is not habit-forming and can be used for longer periods, but it should be taken consistently at the same time each night for best results 1.
• Patients should avoid alcohol while taking trazodone as it can increase sedation and side effects, and if discontinuing trazodone after regular use, it's advisable to taper off gradually rather than stopping abruptly to avoid withdrawal symptoms 1.

Overall, the guidelines recommend against the use of trazodone for treating chronic insomnia disorder due to its adverse effect profile outweighing its benefits, and instead suggest the use of nonbenzodiazepine BZRAs or other treatments with a more favorable risk-benefit profile 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 dose may be increased by 50 mg/day every 3 to 4 days The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses.

The recommended dose and frequency of Trazodone for treating insomnia is not explicitly stated in the drug label for this specific condition. However, for the treatment of depression, an initial dose of 150 mg/day in divided doses is suggested, with the possibility of increasing the dose by 50 mg/day every 3 to 4 days. The occurrence of drowsiness may require administering a major portion of the daily dose at bedtime. The maximum dose for outpatients is usually not to exceed 400 mg/day in divided doses 2.

• Initial dose: 150 mg/day in divided doses
• Dose increase: 50 mg/day every 3 to 4 days
• Maximum dose for outpatients: 400 mg/day in divided doses
• Administration: A major portion of the daily dose may be administered at bedtime if drowsiness occurs.

From the Research

Trazodone Dose and Frequency for Insomnia

• The recommended dose of Trazodone for insomnia is typically lower than that used for depression, with studies suggesting doses ranging from 50 mg to 100 mg at bedtime 3, 4.
• A study published in 1990 found 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, but this may not be necessary for insomnia treatment 5.
• Research suggests that Trazodone is effective in improving sleep in patients with insomnia, with one study finding that 50 mg of Trazodone administered 30 minutes before bedtime improved sleep maintenance and reduced nighttime awakenings 3.
• The frequency of Trazodone administration for insomnia is typically once daily, taken at bedtime, as its 3- to 9-hour half-life and pharmacokinetics favor a dose weighted at bedtime 5.
• A systematic review published in 2017 found that the evidence supports the efficacy and general safety of low-dose Trazodone for the treatment of insomnia, with doses typically ranging from 50 mg to 100 mg at bedtime 6.
• Another study published in 2021 found that Trazodone is less effective than hypnotics in the treatment of sleep onset insomnia, but is very effective in the treatment of sleep-maintenance insomnia, especially in patients with comorbid mental disorders or patients treated with activating antidepressants 4.

Side Effects and Considerations

• Trazodone can cause side effects such as sedation, dizziness, and psychomotor impairment, which may be a concern in the elderly or in patients with certain medical conditions 7.
• A review of the literature published in 2005 found that the evidence for the efficacy of Trazodone in treating insomnia is limited, and that side effects associated with Trazodone are not inconsequential, with a high incidence of discontinuation due to side effects 7.
• Trazodone has been found to increase the duration of deep sleep, which is associated with better sleep quality, whereas hypnotics decrease slow-wave activity in sleep EEG, which is the biomarker of deep sleep 4.