What is the recommended starting and maximum dose of trazodone for insomnia in adults, including adjustments for patients ≥65 years or with hepatic impairment, and what are its contraindications and alternative treatments?

Trazodone Dosing for Insomnia

Guideline Position: Trazodone Is NOT Recommended

The American Academy of Sleep Medicine explicitly recommends AGAINST using trazodone for insomnia treatment. 1, 2 This is a formal guideline recommendation based on clinical trials showing that trazodone 50 mg produces only minimal, clinically insignificant improvements: approximately 10 minutes shorter sleep latency, 22 minutes longer total sleep time, and 8 minutes less wake after sleep onset—all below the threshold for clinical significance. 1, 2

Critically, subjective sleep quality showed no improvement versus placebo, and adverse events occurred in 75% of trazodone users versus 65% on placebo, with headache (30%) and somnolence (23%) being most common. 1, 2 The guideline task force concluded that potential harms outweigh the modest benefits. 1, 2

If Trazodone Is Used Despite Recommendations

Starting Dose

• 25–50 mg at bedtime is the typical off-label dosing range for insomnia. 1, 3, 4
• The clinical trials that informed the recommendation against trazodone used 50 mg doses. 1
• Lower doses (25 mg) have not been systematically studied and would likely provide even less benefit than the already insufficient effects at 50 mg. 1

Maximum Dose for Insomnia

• 50–150 mg at bedtime represents the upper range used in insomnia studies. 1, 3
• Note that doses ≥150 mg approach antidepressant dosing and are not appropriate for insomnia alone. 1, 5

Special Population Adjustments

Elderly Patients (≥65 years)

• Reduce dose and use extreme caution due to increased risk of orthostatic hypotension, falls, dizziness, and daytime drowsiness. 1, 2
• The American Academy of Sleep Medicine specifically warns about these risks in older adults. 1
• Start at 25 mg if trazodone must be used, and monitor closely for adverse effects. 1

Hepatic Impairment

• Dose reduction is required in patients with hepatic impairment. 1
• Use with caution as trazodone clearance is reduced. 1
• Start at the lowest dose (25 mg) and titrate slowly if needed. 1

Administration Instructions

• Take at least 1 hour before bedtime on an empty stomach to maximize effectiveness. 1
• Ensure 7–8 hours of sleep opportunity to reduce residual sedation. 1

Contraindications and Cautions

Absolute Cautions

• Compromised respiratory function (asthma, COPD, sleep apnea)—use with extreme caution. 1
• Hepatic impairment or heart failure—requires dose reduction and close monitoring. 1
• Pregnancy and nursing—trazodone should be avoided. 1

Drug Interactions

• Avoid alcohol and other CNS depressants due to additive sedative effects. 1
• Caution with benzodiazepines—risk of oversedation. 1
• Caution with opioids (e.g., hydrocodone)—FDA black box warning for combined use with sedating medications due to risk of respiratory depression and death. 1

Serious Adverse Effects

• Priapism (medical emergency)—any prolonged, painful erection >4 hours requires immediate emergency care. 1
• Orthostatic hypotension and dizziness—patients should rise slowly from seated or supine positions. 1
• Complex sleep behaviors (sleep-driving, sleep-walking)—monitor at every visit and discontinue immediately if they occur. 1

Evidence-Based Alternatives (Strongly Preferred)

First-Line: Cognitive Behavioral Therapy for Insomnia (CBT-I)

• CBT-I must be offered as initial treatment before any medication—it demonstrates superior long-term efficacy with sustained benefits after discontinuation. 1, 2, 6

Second-Line: FDA-Approved Pharmacotherapy

For Sleep Onset AND Maintenance:

• Eszopiclone 2–3 mg (reduce to 1 mg in elderly or hepatic impairment)—increases total sleep time by 28–57 minutes. 1, 2
• Zolpidem 10 mg (5 mg in elderly)—reduces sleep latency by 25 minutes. 1, 2

For Sleep Onset Only:

• Zaleplon 10 mg (5 mg in elderly)—very short-acting with minimal next-day sedation. 1, 2
• Ramelteon 8 mg—preferred when substance-use history exists (no addiction potential). 1, 2

For Sleep Maintenance Only:

• Low-dose doxepin 3–6 mg—reduces wake after sleep onset by 22–23 minutes with minimal anticholinergic effects and no abuse potential. 1, 2, 6
• Suvorexant 10 mg—orexin-receptor antagonist with lower cognitive impairment risk. 1, 2

Clinical Algorithm When Trazodone Is Considered

1. First, ask: Is there comorbid depression?

   • If YES and depression requires treatment → Use full antidepressant dosing (150–300 mg), NOT insomnia dosing. 1
   • If YES but depression is mild → Consider low-dose doxepin 3–6 mg or mirtazapine 7.5–15 mg instead. 1, 4
   • If NO depression → Do NOT use trazodone; use FDA-approved hypnotics listed above. 1, 2

2. Second, has CBT-I been initiated?

   • If NO → Start CBT-I immediately before or alongside any medication. 1, 2
   • If YES and insufficient → Proceed to FDA-approved hypnotics, not trazodone. 1, 2

3. Third, have FDA-approved first-line agents failed?

   • If NO → Try eszopiclone, zolpidem, or low-dose doxepin first. 1, 2
   • If YES → Trazodone may be considered as a third-line agent, but only after benzodiazepine receptor agonists and ramelteon have failed. 1

Common Pitfalls to Avoid

• Using trazodone as first-line therapy—guidelines explicitly recommend against this. 1, 2
• Prescribing trazodone without attempting CBT-I first—behavioral therapy is the standard of care. 1, 2
• Using 50 mg doses in elderly patients without dose reduction—significantly increases fall and orthostatic hypotension risk. 1, 2
• Combining trazodone with other sedating medications (benzodiazepines, opioids)—creates dangerous additive CNS depression. 1
• Assuming trazodone is "safer" than FDA-approved hypnotics—the evidence does not support a superior safety profile. 1
• Using low doses (25–50 mg) to treat comorbid depression—these doses are inadequate for antidepressant effect. 1

Monitoring Requirements

• Reassess after 1–2 weeks for efficacy (sleep latency, total sleep time, nocturnal awakenings, daytime functioning) and adverse effects. 1, 2
• Use the lowest effective dose for the shortest duration possible. 1, 2
• Taper gradually when discontinuing to avoid rebound insomnia, using CBT-I to support cessation. 1
• Regular follow-up to assess ongoing need for medication and to facilitate eventual discontinuation. 1