Is trazodone a scheduled drug?

From the Guidelines

Trazodone is not a scheduled drug under the U.S. Controlled Substances Act. It is a prescription-only antidepressant medication that does not have significant potential for abuse or dependence compared to controlled substances. According to the provided evidence, trazodone is mentioned as a sedating low-dose antidepressant that may be considered for patients with comorbid depression or in the case of other treatment failures 1. The fact that it is discussed alongside other treatment options for insomnia without any mention of scheduling restrictions suggests that it is not a controlled substance. Trazodone works primarily as a serotonin antagonist and reuptake inhibitor (SARI) and is commonly prescribed for depression, anxiety, and insomnia. While it requires a prescription from a healthcare provider, it doesn't carry the same restrictions as scheduled medications like benzodiazepines or opioids. This classification reflects trazodone's relatively low risk profile for addiction or misuse, though it still requires medical supervision due to potential side effects including drowsiness, dizziness, and cardiac effects. Patients should always take trazodone exactly as prescribed and not adjust dosing without consulting their healthcare provider. Key points to consider when prescribing trazodone include:

• Its efficacy as a sleep aid, particularly when used in conjunction with another full-dose antidepressant 1
• Its relatively low risk of anticholinergic activity compared to other sedating antidepressants like doxepin and amitriptyline 1
• The potential for side effects, which should be carefully monitored and managed by a healthcare provider.

From the FDA Drug Label

1. Drug Abuse and Dependence 9.1 Controlled Substance Trazodone Hydrochloride Tablets are not a controlled substance.

• Trazodone is not a scheduled drug, as it is explicitly stated that it is not a controlled substance 2.

From the Research

Trazodone Classification

• Trazodone is not explicitly stated as a scheduled drug in the provided studies 3, 4, 5, 6, 7.

Regulatory Status

• The studies focus on the pharmacological properties, clinical efficacy, and safety of trazodone for the treatment of major depressive disorder (MDD) and related conditions 3, 4, 5, 6, 7.
• There is no mention of trazodone being classified as a scheduled drug, which suggests that it may not be regulated as a controlled substance in the same way as some other medications.

Clinical Use

• Trazodone is approved for the treatment of MDD in adults and is available in various formulations, including immediate release, prolonged release, and once-a-day formulations 3, 4, 5, 6, 7.
• The drug has a favorable profile for the treatment of depression, with a low risk of anticholinergic side effects, weight gain, and sexual side effects 6.