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 recommended by the American Academy of Sleep Medicine 1. When considering trazodone for insomnia, the typical dose range is 50 to 150 mg before bedtime, as reported in a systematic review 1. However, the evidence supporting its efficacy is low-quality and outweighed by its adverse effect profile. Some key points to consider when prescribing trazodone for insomnia include:
- Starting with a low dose, such as 50 mg, and gradually increasing as needed and tolerated
- Taking the medication with food to reduce side effects like dizziness and nausea
- Being aware of common side effects, including drowsiness, dizziness, dry mouth, and occasionally priapism in men
- Considering alternative treatments for insomnia, such as cognitive-behavioral therapy for insomnia (CBT-I) or other pharmacologic agents with a more favorable risk-benefit profile, as recommended by the American Academy of Sleep Medicine 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. 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. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.
The recommended initial dose of trazodone is 150 mg/day in divided doses. The dose can be increased by 50 mg/day every 3 to 4 days. The maximum dose is:
- 400 mg/day in divided doses for outpatients
- 600 mg/day in divided doses for inpatients 2
From the Research
Trazodone Dosing Regimen
- The appropriate antidepressant doses of trazodone are usually 150-300 mg/day 3, 4
- Trazodone is best dosed at 150 mg given predominantly at bedtime and increased as needed to 200 to 300 mg for full antidepressant efficacy 3
- Studies comparing multiple daytime dosing to single dosing at bedtime have shown equal efficacy in relieving depression 3
- In geriatric patients, lower doses are recommended, usually 75 to 600mg daily 5
Factors Influencing Dosing
- The 3- to 9-hour half-life of trazodone and its pharmacokinetics favor a dose weighted at bedtime 3
- Trazodone is metabolised by the CYP450 isoenzyme, mainly the 2D6 and 3A4, which requires its dose to be adjusted when administered simultaneously with other drugs influencing the activity of those isoenzymes 5
- The presence of comorbid conditions such as insomnia, anxiety, or psychomotor agitation may influence the dosing regimen 4, 6
Efficacy and Tolerability
- Trazodone has been shown to be effective in reducing the severity of depression, anxiety, and insomnia 7
- Trazodone is usually well tolerated and has a low risk of anticholinergic side effects, weight gain, and sexual side effects 4, 5, 6
- The most common side effects of trazodone are somnolence, dizziness, gastrointestinal dysfunctions, and dry mouth 5