Trazodone Should Not Be Used for Primary Insomnia
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
Why Trazodone Is Not Recommended
The evidence against trazodone for insomnia is clear and consistent:
Clinical trials of trazodone 50 mg showed only modest improvements in objective sleep parameters compared to placebo, with no significant improvement in subjective sleep quality. 1, 2
The VA/DOD guidelines also explicitly advise against trazodone use for chronic insomnia disorder. 1
The harms outweigh the benefits according to the American Academy of Sleep Medicine, which assigned a "WEAK" recommendation against its use based on low-quality evidence. 1, 2
A systematic review found no differences in sleep efficiency between trazodone (50-150 mg) and placebo in patients with chronic insomnia. 1
Significant Safety Concerns
Trazodone carries a concerning adverse effect profile that particularly impacts clinical decision-making:
Daytime drowsiness, dizziness, and psychomotor impairment are common, with high discontinuation rates due to side effects. 1, 3
Cognitive impairments include deficits in short-term memory, verbal learning, and equilibrium, even at the 50 mg dose commonly used for insomnia. 4
Elderly patients are at particular risk for falls and cognitive impairment from these sedating effects. 1, 3
Serious adverse effects include priapism, which has led to treatment discontinuation in clinical studies. 1
Recommended Treatment Algorithm
First-Line Treatment:
- Cognitive Behavioral Therapy for Insomnia (CBT-I) is the initial treatment of choice for chronic insomnia, including components such as cognitive therapy, stimulus control therapy, and sleep restriction therapy. 1, 2
Second-Line Pharmacological Options:
When medication is necessary, use these FDA-approved agents instead of trazodone:
For sleep onset AND maintenance insomnia:
For sleep onset insomnia only:
For sleep maintenance insomnia only:
Third-Line Consideration:
- Trazodone is relegated to third-line status, only after benzodiazepine receptor agonists and ramelteon have failed. 1
The One Exception: Comorbid Depression
Trazodone may be considered when comorbid depression or anxiety is present, as this represents a different clinical scenario than primary chronic insomnia. 1 In this specific context:
- The guidelines' recommendations against trazodone are based on treating primary chronic insomnia, not insomnia secondary to psychiatric conditions. 1
- Lower doses (25-50 mg) are typically used for insomnia, which are below the therapeutic antidepressant range. 1
Critical Prescribing Principles
If trazodone is used despite guideline recommendations:
- Use the lowest effective dose and shortest possible duration. 1, 2
- Regular follow-up is essential to assess effectiveness, side effects, and ongoing need for treatment. 1, 2
- Administer on an empty stomach to maximize effectiveness. 1
- Exercise caution with concurrent sedating medications due to additive effects. 1
- Counsel patients about allowing appropriate sleep time and potential side effects. 1
Common Pitfall to Avoid
Despite trazodone being the second most commonly prescribed agent for insomnia due to its sedating qualities 3, this widespread off-label use is not supported by evidence and contradicts current clinical practice guidelines. 1, 2 The popularity of trazodone for insomnia reflects historical prescribing patterns rather than evidence-based medicine.