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Is naltrexone a controlled substance?

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on July 7, 2020.

Official Answer

by Drugs.com

No, naltrexone is not classified as a controlled substance by the U.S. Drug Enforcement Agency (DEA). Naltrexone is a full opioid antagonist that blocks euphoric actions only (meaning it can't lead to addiction or a "high"). Naltrexone is approved for use in the treatment plan of patients with Opioid Use Disorder (OUD) or alcohol dependence, along with counseling. Any doctor can prescribe naltrexone.

How does naltrexone come?

Naltrexone is available as a long-acting intramuscular injection (brand name: Vivitrol) or as generic 50 mg oral tablets. There is no generic available for Vivitrol to date.

Vivitrol is used to prevent relapse in the treatment of alcohol dependence or opioid use disorder. It may be beneficial for patients who have trouble sticking to the oral treatment regimen. Vivitrol can help block cravings for one month with one injection. It's available in a 380 mg strength and was first approved in 2006.

Vivitrol is only available from certified specialty pharmacies, who will ship the medicine to your doctor each month before your injection. Your health care provider will help you fill out the forms you need and give you the injections each month in their office.

Oral naltrexone tablets are given once a day. The 50-mg oral tablets have an effect that lasts 24 hours.

Opioid Use Disorder (OUD)

Oral naltrexone is one option for motivated patients with milder symptoms of OUD who can be reliably followed for medication compliance. However, poor adherence has limited the use of oral naltrexone for OUD. Clinical studies have shown greater effectiveness with methadone or buprenorphine treatment for OUD.

Naltrexone can precipitate withdrawal symptoms if you still use narcotics and should not be used prior to completion of a medically-supervised opioid withdrawal, usually at least 7 to 10 days.

Alcohol Dependence

For treatment of alcohol dependence, patients should NOT be actively drinking at the time they start Vivitrol treatment.

What are the side effects with naltrexone?

Naltrexone may precipitate a mild to possibly severe withdrawal in individuals physically dependent on opiates. More common side effects reported with naltrexone include:

  • stomach cramping or pain
  • headache
  • dizziness
  • injection site reaction like pain or tenderness (Vivitrol only)
  • anxiety, nervousness
  • trouble sleeping
  • joint and muscle pain
  • nausea or vomiting
  • fatigue

Bottom Line

  • Naltrexone is not classified as a controlled substance. It's a full opioid antagonist that blocks euphoric actions at the opioid receptor (meaning it can't lead to a "high" or addiction).
  • It is used as one part of the treatment plan of patients with alcohol dependence or opioid use disorder, along with counseling. Naltrexone is not a cure for drug addiction or alcoholism.
  • It is available by prescription as a long-acting intramuscular injection (brand name: Vivitrol) or as a 50 mg oral tablet (generic). Vivitrol is not yet available in generic form.

This is not all the information you need to know about naltrexone for safe and effective use. Review the full naltrexone or Vivitrol information here, and discuss this information with your doctor or other health care provider.

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