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Desyrel (trazodone)
Serotonin antagonist and reuptake inhibitor (SARI) that blocks 5-HT2A receptors and H1 receptors, used primarily as a sedative-hypnotic at low doses.
Trazodone is an antidepressant far more commonly prescribed as a sleep aid at low doses. Approved in 1981. One of the top prescribed medications overall. Available generically at very low cost.
At a glance
| Generic name | trazodone |
|---|---|
| Also known as | Desyrel, Oleptro |
| Sponsor | Generic (originally Angelini/Pragmaten) |
| Drug class | SARI (Serotonin antagonist and reuptake inhibitor) |
| Target | HLA class I histocompatibility antigen, A-3 alpha chain, D(4) dopamine receptor, 5-hydroxytryptamine receptor 1A |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 1981-12-24 (United States) |
Mechanism of action
Trazodone is approved as an antidepressant but is far more commonly prescribed at low doses (25-100mg) as a sleep aid due to its sedating H1 and 5-HT2A antagonism. At antidepressant doses (150-600mg) it inhibits serotonin reuptake and blocks 5-HT2A receptors. One of the most prescribed medications for insomnia despite this being off-label.
Approved indications
- Major depressive disorder
Boxed warnings
- WARNING: SUICIDAL THOUGHTS and BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . Trazodone is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . WARNING: SUICIDAL THOUGHTS and BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Trazodone is not approved for use in pediatric patients ( 8.4 )
Common side effects
- Edema
- Blurred vision
- Syncope
- Drowsiness
- Fatigue
- Diarrhea
- Nasal congestion
- Weight loss
- Akathisia
- Allergic reaction
- Anemia
- Chest pain
Serious adverse events
- Suicidal thoughts and behavior
- Serotonin syndrome
- Cardiac arrhythmias
- Orthostatic hypotension
- Myocardial infarction
- Cardiac arrest
- Ventricular tachycardia
- Torsade de pointes
- Priapism
- Cerebrovascular accident
Key clinical trials
- Treatment-Resistant Depression, Hippocampus Atrophy and Serotonin Genetic Polymorphism (Phase 4)
- A Randomized, Two-way Crossover Study to Compare the Bioavailability of 300 mg Trazodone Hydrochloride Extended-release Caplets (Containing Contramid®) (Administered as a Single Dose) and 100 mg Trazo (Phase 1)
- Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons: a Pilot Study (Phase 4)
- Quetiapine Augmentation of Prolonged Exposure (PE) Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury (EARLY/Phase 1)
- The Effects of Trazodone on the Severity of Obstructive Sleep Apnea (NA)
- Algorithm Guided Treatment Strategies for Major Depressive Disorder (Phase 4)
- Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder. (Phase 2)
- Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Desyrel CI brief — competitive landscape report
- Desyrel updates RSS · CI watch RSS
- Generic (originally Angelini/Pragmaten) portfolio CI