Is naltrexone (Naltrexone) approved for maintaining remission in alcohol use disorder (alcohol abuse)?

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Last updated: April 1, 2025View editorial policy

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From the Guidelines

Naltrexone is approved for treating alcohol use disorder, including during remission, as it helps maintain abstinence and prevent relapse in patients who have already stopped drinking. The standard oral dose is 50 mg once daily, though some patients may start at 25 mg to minimize side effects 1. Naltrexone works by blocking opioid receptors in the brain, reducing the pleasurable effects of alcohol and decreasing cravings. It's particularly effective when used as part of a comprehensive treatment program that includes counseling and support groups.

Key Points to Consider

  • Naltrexone can help maintain abstinence and prevent relapse in patients who have already stopped drinking 1.
  • Common side effects include nausea, headache, dizziness, and fatigue.
  • It's contraindicated in patients taking opioid medications or with acute hepatitis or liver failure.
  • Liver function should be monitored during treatment 1.
  • Patients should carry medical identification indicating they are taking naltrexone, as it blocks the effects of opioid pain medications that might be needed in emergency situations.

Treatment Recommendations

  • Pharmacological treatment, including naltrexone, must be considered for promoting the maintenance of alcohol consumption targets (abstinence or reduced consumption) in dependent patients 1.
  • A careful assessment of the benefit-risk ratio is necessary when prescribing naltrexone or other medications for alcohol use disorder.

From the FDA Drug Label

INDICATIONS AND USAGE Naltrexone hydrochloride tablets USP 50 mg is indicated in the treatment of alcohol dependence The FDA drug label does not answer the question.

From the Research

Naltrexone Approval for Alcohol Abuse in Remission

  • Naltrexone is approved by the United States of America Food and Drug Administration for the treatment of alcohol dependence, as stated in the study 2.
  • The medication has been shown to significantly reduce the risk of relapsing to heavy drinking compared to placebo, with a modest effect size in the range of 0.15 to 0.2 2.
  • Naltrexone is effective in reducing relapse to heavy drinking, but less effective in enhancing abstinence, according to meta-analyses of clinical trials 2, 3, 4.

Efficacy and Safety of Naltrexone

  • The tolerability of naltrexone is reasonable, with the most common side-effect being nausea, and hepatotoxicity is not a clinical problem at the standard 50 mg dose 2.
  • Naltrexone's side effects are more numerous compared to acamprosate, yet the drug is tolerated acceptably without being associated with a lower adherence to treatment 3.
  • The length of treatment with naltrexone has not been well studied, but many clinicians recommend one year of treatment 2.

Combination Therapy with Naltrexone

  • The combination of naltrexone and acamprosate is a reasonable treatment option for relapse prevention in patients with alcohol dependence, and has been described to be safe and effective in clinical studies 5, 6.
  • The efficacy profiles of naltrexone and acamprosate are different, with naltrexone preventing excessive drinking and acamprosate supporting abstinence, and the choice of treatment may depend on the therapeutic target 4.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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