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Is trazodone a controlled substance?

Medically reviewed by Sally Chao, MD. Last updated on Sep 1, 2021.

Official answer

by Drugs.com

The U.S. Food and Drug Administration (FDA) does not recognize trazodone as a controlled substance because studies have not shown that people who take trazodone are likely to start abusing the drug.

A controlled substance is an illegal or prescription drug deemed addictive or inclined to result in drug abuse and dependency. These drugs are categorized into different "schedules," with schedule I indicating that a drug has no medical use and the highest chance of resulting in dependence. Schedule II, III, IV and V indicate gradually more medical uses and less addictive properties. Schedule V drugs have the lowest potential for abuse.

Trazodone is not a narcotic either. Narcotics are opioids—drugs that relieve pain by blocking the pain receptors in your brain. Trazodone is an antidepressant medication that alters brain chemicals, called neurotransmitters, to help ease depression. As it interacts with these complex parts of the brain, it also can induce sleepiness, which is why doctors will sometimes prescribe it off-label for insomnia.

While trazodone is not a narcotic or a controlled substance, specific research on the abuse potential of trazodone is lacking. Clinical trials of trazodone did not show any signs of drug-seeking behavior.

Trazodone is intended for use in people with depression. However, trazodone is often prescribed off-label for other conditions, such as insomnia, and the drug's abuse potential has not been studied for these uses.

Trazodone is generally prescribed in much lower doses for people with insomnia versus those with depression. Other medicines that are sometimes indicated for insomnia, such as benzodiazepines, come with a higher risk of inducing dependency than trazodone. Despite the lack of evidence, trazodone is generally considered to have a low potential for abuse.

References
  1. U.S. Food and Drug Administration (FDA). DESYREL® (trazodone hydrochloride) tablets, for oral use. Last updated June 2017. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018207s032lbl.pdf. [Accessed August 3, 2021].
  2. United States Drug Enforcement Administration (DEA). 2020 Drugs of Abuse Resource Guide. Available at: https://www.dea.gov/sites/default/files/2020-04/Drugs%20of%20Abuse%202020-Web%20Version-508%20compliant-4-24-20_0.pdf. [Accessed August 3, 2021].
  3. Jaffer KY, Chang T, Vanle B, et al. Trazodone for Insomnia: A Systematic Review. Innov Clin Neurosci. 2017;14(7-8):24-34. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5842888/.
  4. Sateia MJ, Buysse DJ, Krystal AD, et al. Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2017;13(2):307–349. https://doi.org/10.5664/jcsm.6470.
  5. Patel D, Steinberg J, Patel P. Insomnia in the Elderly: A Review. J Clin Sleep Med. 2018;14(6):1017-1024. Published 2018 Jun 15. https://doi.org/10.5664/jcsm.7172.
  6. Schroeck JL, Ford J, Conway EL, et al. Review of Safety and Efficacy of Sleep Medicines in Older Adults. Clin Ther. 2016;38(11):2340-2372. https://doi.org/10.1016/j.clinthera.2016.09.010.
  7. Friedmann PD, Rose JS, Swift R, et al. Trazodone for sleep disturbance after alcohol detoxification: a double-blind, placebo-controlled trial. Alcohol Clin Exp Res. 2008;32(9):1652-1660. https://doi.org/10.1111/j.1530-0277.2008.00742.x.

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