For research and educational purposes only. Not medical advice.

Trazodone Reference

Educational, not medical advice reference for Trazodone: Sleep; regulatory status, evidence posture, source review, and schedule notes. Also kno…

Plain English

What it is
Trazodone is a prescription antidepressant. The FDA approved it to treat major depression, and it is sold under brand names like Desyrel and the extended-release Oleptro. It is not a controlled substance.
What people use it for
Even though it is approved for depression, doctors very commonly prescribe small amounts of it at night to help people fall asleep. This sleep use is off-label, which means the FDA has not approved it for sleep.
What the science shows
As a depression medicine it is well established. For sleep, the evidence is much thinner. A widely cited review notes there is very little data showing it improves sleep in people who are not depressed, even though it is prescribed for sleep about as often as the leading sleep drug.
The catch
It is prescription-only. A rare but serious side effect is priapism, a long-lasting and sometimes painful erection that needs emergency medical care right away. It can also cause next-day drowsiness and dizziness from low blood pressure when standing up.

Reference summary

James & Mendelson 2004 J Clin Psychiatry is the critical-review reference for trazodone's off-label hypnotic use. Low-dose trazodone is one of the most commonly prescribed off-label hypnotics in primary care because it is not a controlled substance, has low dependence potential, and avoids the complex-sleep-behavior risk that defines the Z-drug class. The trade-off is daytime sedation, orthostatic hypotension, and rare but real priapism risk.

Regulatory and posture

Categories
Sleep
Aliases
Desyrel, Oleptro, Serotonin antagonist and reuptake inhibitor (SARI, small molecule, not a peptide)
Evidence posture
human - Off-label hypnotic use is widely practiced but is not FDA-approved. Priapism is a rare label-level warning that requires immediate medical attention.
Regulatory status
FDA-approved as Desyrel (1981) and as extended-release Oleptro (2010) for the treatment of major depressive disorder. Off-label use at low doses (25 to 100 mg at bedtime) for insomnia is widely practiced but is not an FDA-approved indication.
Content review status
label verified

Selected public sources

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