Trazodone Dosing for Sleep in Adults
Primary Recommendation
The American Academy of Sleep Medicine explicitly recommends against using trazodone for either sleep onset or sleep maintenance insomnia in adults, and clinicians should consider FDA-approved alternatives first. 1, 2, 3
Evidence Against Trazodone for Insomnia
The recommendation against trazodone is based on moderate-quality evidence demonstrating clinically insignificant benefits:
- Sleep latency reduced by only 10.2 minutes (below clinical significance threshold) 1, 3
- Total sleep time increased by only 21.8 minutes (clinically insignificant) 1, 3
- Wake after sleep onset reduced by only 7.7 minutes (below threshold) 1, 3
- Sleep quality showed no significant improvement versus placebo (−0.13 points on 4-point scale) 1, 3
- Adverse events occurred in 75% of trazodone subjects versus 65.4% on placebo, with headache (30% vs 19%) and somnolence (23% vs 8%) being most common 1
The task force concluded that harms potentially outweigh benefits for primary insomnia treatment. 1
If Trazodone Must Be Used Despite Guidelines
Dosing Protocol
If prescribed despite the recommendation against use, the evidence-based dose is 50 mg taken 30 minutes to 1 hour before bedtime. 1, 4, 5
- The 50 mg dose is the only systematically studied dose for primary insomnia in guideline-quality trials 1
- Lower doses (25 mg) have not been systematically studied and would likely provide even less benefit than the already insufficient 50 mg dose 2
- For insomnia with comorbid depression, doses of 50-100 mg at bedtime have been studied, with 100 mg showing better efficacy 4
- Trazodone should be taken shortly after a meal or light snack per FDA labeling 6
Important Timing Consideration
Trazodone requires administration at least 1 hour before bedtime for sleep onset insomnia, unlike hypnotics which can be taken immediately before bed. 5 This is a critical practical difference that affects its utility for sleep initiation.
Preferred FDA-Approved Alternatives
The American Academy of Sleep Medicine recommends these evidence-based options instead:
For Sleep Onset Insomnia:
- Zolpidem 10 mg at bedtime 2, 3
- Zaleplon 10 mg at bedtime 2, 3
- Ramelteon 8 mg at bedtime 2, 3
- Eszopiclone 2-3 mg at bedtime 2, 3
For Sleep Maintenance Insomnia:
- Doxepin 3-6 mg at bedtime 2, 3
- Suvorexant at bedtime 2
- Eszopiclone 2-3 mg at bedtime 2, 3
- Temazepam 15-30 mg at bedtime 2, 3
When Trazodone May Be Appropriate (Third-Line)
Trazodone should only be considered as a third-line agent after FDA-approved hypnotics and ramelteon have failed, or when specific comorbidities exist. 2, 3
Specific Clinical Scenarios:
- Comorbid depression with insomnia - though low doses (25-50 mg) used for insomnia are inadequate for treating major depression and may require combination with a full-dose antidepressant 2, 3
- Insomnia secondary to activating antidepressants - trazodone is particularly effective for sleep maintenance in this context 5
- After failure of first and second-line treatments 2, 3
Advantages in Select Populations:
- Increases slow-wave (deep) sleep, which may improve subjective sleep quality, unlike hypnotics which decrease slow-wave activity 5
- Lower risk of weight gain compared to other sedating antidepressants 5
- Effective for sleep maintenance insomnia more than sleep onset 5
Critical Safety Considerations and Monitoring
High-Risk Populations Requiring Caution:
- Elderly patients - increased risk of orthostatic hypotension, falls, and daytime drowsiness; consider dose reduction 2, 3
- Hepatic impairment - requires dose reduction 2
- Renal impairment - use with caution 2
- Compromised respiratory function - use with caution 2
- Cardiac disease - use with caution 2
- Pregnancy and nursing - should be avoided 2
Documented Daytime Impairments:
Even at 50 mg, trazodone produces measurable next-day effects including:
- Short-term memory impairment 7
- Verbal learning deficits 7
- Equilibrium disturbances (increased body sway) 7
- Reduced muscle endurance 7
These impairments persist despite improved nighttime sleep. 7
Mandatory Patient Education:
- Allow adequate sleep time (7-8 hours) before activities requiring alertness 2
- Risk of daytime drowsiness and psychomotor impairment 2
- Take on empty stomach for maximum effectiveness 2
- Avoid combining with other sedating medications without medical supervision 2
Drug Interactions:
- Strong CYP3A4 inhibitors - consider dose reduction 6
- Strong CYP3A4 inducers - may need dose increase 6
- MAOIs - at least 14 days must elapse between discontinuation of MAOI and trazodone initiation 6
- Other sedating medications - additive sedation risk 2
Follow-Up Requirements
Regular assessment is essential if trazodone is prescribed: 2, 3
- Evaluate every few weeks initially
- Monitor for effectiveness and adverse effects
- Employ lowest effective maintenance dose
- Taper medication when conditions allow rather than abrupt discontinuation 6
Common Pitfalls to Avoid
- Never use trazodone as first-line therapy for primary insomnia 2
- Never prescribe without attempting cognitive behavioral therapy for insomnia (CBT-I) or FDA-approved hypnotics first 2
- Never combine two sedating antidepressants 2
- Never stop abruptly - gradually reduce dosage to avoid withdrawal symptoms 6
- Never assume low doses treat depression - 25-50 mg is inadequate for antidepressant effect 2, 3