What is the maximum dose of trazodone (antidepressant) for insomnia?

Maximum Dose of Trazodone for Insomnia

The maximum dose of trazodone for insomnia should not exceed 200 mg at bedtime, though major guidelines explicitly recommend against using trazodone for insomnia at all due to limited efficacy and potential harms. 1

Guideline Recommendations Against Trazodone for Insomnia

• The American Academy of Sleep Medicine gives trazodone a "WEAK" recommendation AGAINST use for sleep onset or sleep maintenance insomnia in adults, stating that potential harms outweigh benefits. 1
• The Department of Veterans Affairs/Department of Defense guidelines similarly advise against trazodone for chronic insomnia disorder. 1
• Clinical trials demonstrate only modest improvements: trazodone 50 mg reduces sleep latency by just 10 minutes with no improvement in subjective sleep quality compared to placebo. 1
• The 2008 American Academy of Sleep Medicine guideline notes that evidence for sedating low-dose antidepressants like trazodone is "relatively weak" and recommends them only after other treatment failures or when comorbid depression exists. 2

Dosing Algorithm If Trazodone Is Used Despite Guidelines

If trazodone is prescribed off-label for insomnia (against guideline recommendations), follow this dosing approach:

• Start with 25 mg at bedtime, which represents the lowest dose providing sedative effects while minimizing adverse effects. 1
• Increase to 50 mg after 1-2 weeks if the initial dose is inadequate. 1, 3
• The maximum dose for insomnia is 200 mg at bedtime—do not exceed this. 1
• Administer on an empty stomach to maximize effectiveness (contrary to FDA depression dosing which recommends taking with food). 1
• Ensure 7-8 hours of sleep time is available to minimize next-day sedation. 1

Context: FDA-Approved Dosing vs. Off-Label Insomnia Use

The FDA-approved dosing for depression starts at 150 mg/day in divided doses, with outpatient maximum of 400 mg/day and inpatient maximum of 600 mg/day. 4 However, insomnia treatment uses substantially lower doses (25-200 mg) that are below the therapeutic antidepressant range. 1 This creates a critical distinction: the 200 mg maximum for insomnia is based on off-label use patterns and safety considerations, not FDA approval for this indication.

Evidence Supporting the 200 mg Maximum

• A retrospective study of 74 male veterans with PTSD-related nightmares found the mean effective dose was 212 mg/day, but 60% experienced side effects (particularly daytime sedation or dizziness) and 14 participants discontinued due to intolerable effects including priapism. 2
• Studies from the 1980s-1990s used doses of 100-400 mg for depression with sleep benefits, but modern practice for primary insomnia uses lower doses (25-100 mg). 5, 6
• A dose-finding study confirmed that 50-100 mg/day improved sleep disorders, with optimal effects at 100 mg/day. 3

Safety Concerns and Special Populations

• Elderly patients require dose reduction due to increased sensitivity to sedative and orthostatic effects. 1
• Avoid in pregnancy, nursing, compromised respiratory function, hepatic or heart failure. 1
• Caution with alcohol-dependent patients: A 2008 randomized controlled trial found trazodone (50-150 mg) impeded improvements in alcohol consumption post-detoxification and led to increased drinking when stopped, despite short-term sleep benefits. 7
• Consider dose reduction when coadministered with strong CYP3A4 inhibitors. 4

Preferred Treatment Algorithm

Follow this stepwise approach instead of starting with trazodone:

1. First-line: Offer Cognitive Behavioral Therapy for Insomnia (CBT-I) for all patients with chronic insomnia. 1

2. Second-line pharmacotherapy options (if CBT-I fails or is unavailable):

   • Zolpidem 5-10 mg (start 5 mg in women/elderly) 1
   • Eszopiclone 2-3 mg for sleep maintenance 1
   • Zaleplon 10 mg for sleep onset only 1
   • Ramelteon 8 mg for sleep onset (no dependence risk) 1
   • Temazepam 15 mg for both initiation and maintenance 1

3. Only consider trazodone if second-line agents fail OR when comorbid depression/anxiety exists. 1

Common Pitfalls to Avoid

• Do not use trazodone doses above 200 mg for insomnia—this increases side effects without additional sleep benefits and approaches antidepressant dosing ranges. 1
• Do not assume trazodone is safer than FDA-approved hypnotics—the evidence base is weaker and guidelines recommend against its use. 1
• Do not continue trazodone indefinitely without reassessment—tolerance does not occur to sleep effects, but the risk-benefit ratio remains unfavorable compared to alternatives. 5
• Do not prescribe trazodone as first-line therapy—CBT-I and FDA-approved hypnotics have stronger evidence. 1