Trazodone Should NOT Be Used as a Sleep Aid
The American Academy of Sleep Medicine explicitly recommends against using trazodone for sleep onset or sleep maintenance insomnia in adults, and this recommendation should guide clinical practice. 1, 2, 3
Why Trazodone Fails as a Sleep Aid
The evidence against trazodone is clear and consistent:
Clinically insignificant benefits: In the pivotal trial of trazodone 50 mg, improvements in sleep parameters fell below clinical significance thresholds—sleep latency reduced by only 10.2 minutes, total sleep time increased by only 21.8 minutes, and wake after sleep onset decreased by just 7.7 minutes 1
No improvement in sleep quality: Despite modest objective changes, subjective sleep quality showed no meaningful improvement compared to placebo 1, 3
Harms outweigh benefits: The American Academy of Sleep Medicine task force determined that potential harms outweigh the minimal benefits, leading to their recommendation against its use 1, 2
The VA/DOD guidelines similarly advise against trazodone for chronic insomnia disorder 2
Significant Safety Concerns
Trazodone carries a concerning adverse effect profile that makes it particularly problematic:
High side effect burden: 75% of patients experienced adverse events versus 65.4% on placebo, with headache (30% vs 19%) and somnolence (23% vs 8%) being most common 1
Daytime impairment: Trazodone causes significant cognitive and psychomotor impairments including deficits in short-term memory, verbal learning, equilibrium problems, and muscle endurance 4
Serious risks: Priapism (requiring emergency treatment), cardiac arrhythmias (especially in patients with cardiac history), QT prolongation, orthostatic hypotension, and serotonin syndrome 1, 5, 6
Elderly patients face heightened risks of falls, confusion, and cardiovascular complications 2, 5
What You Should Use Instead
First-Line Treatment:
- Cognitive Behavioral Therapy for Insomnia (CBT-I) is the gold standard and should always be offered first 2, 3
Second-Line Pharmacologic Options:
For both sleep onset AND maintenance:
For sleep onset only:
For sleep maintenance only:
Third-Line Consideration (When Appropriate):
Trazodone may only be considered as a third-line agent after benzodiazepine receptor agonists and ramelteon have failed, and specifically when: 2, 3
- Comorbid depression is present requiring full antidepressant dosing (150-300 mg), not the low doses (25-50 mg) typically used for insomnia 2, 7
- The patient is already on a full-dose antidepressant and needs additional sleep support 2
Critical Caveats
Low doses are inadequate: The 25-50 mg doses commonly prescribed for insomnia are below therapeutic antidepressant range and have not been systematically studied for insomnia 2
No tolerance data: There are virtually no data on tolerance to trazodone's hypnotic effects with chronic use 6
Avoid in specific populations: Pregnancy, breastfeeding, cardiac disease (especially QT prolongation), hepatic/renal impairment, and elderly patients require extreme caution or avoidance 2, 5
Drug interactions: Concurrent use with other serotonergic agents (SSRIs, SNRIs, MAOIs, triptans), anticoagulants, or sedating medications increases risk of serious adverse events 5
Never combine two sedating antidepressants: Combining trazodone with other sedating antidepressants carries significant risks including serotonin syndrome, excessive sedation, and QT prolongation 3
The Bottom Line
Despite trazodone's widespread off-label use for insomnia (often exceeding its use as an antidepressant), the evidence does not support this practice 8, 6. The American Academy of Sleep Medicine's recommendation against its use is based on the lack of clinically meaningful efficacy combined with a significant adverse effect profile 1, 2, 3. Prescribers should prioritize CBT-I and FDA-approved hypnotics that have demonstrated superior efficacy and safety profiles for insomnia treatment.