Naltrexone: A Clinically Proven Aid to Reduce Alcohol Consumption
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Naltrexone is a prescription medication approved by the FDA for the treatment of alcohol use disorder (AUD). As an opioid antagonist, it works by blocking the euphoric effects and feelings of intoxication associated with alcohol consumption, thereby helping to reduce cravings and support patients in maintaining abstinence or significantly cutting down their drinking. It is a cornerstone of medication-assisted treatment (MAT) and is most effective when used as part of a comprehensive treatment plan that includes counseling, behavioral therapies, and psychosocial support. This non-addictive pharmaceutical intervention offers a scientifically-backed approach to modifying drinking behaviors and supporting long-term recovery.
Features
- Active Ingredient: Naltrexone Hydrochloride
- Available Formulations: Oral tablets (50 mg) and extended-release intramuscular injection (380 mg/vial)
- Mechanism of Action: Opioid receptor antagonist
- Prescription Status: Schedule-controlled substance requiring medical supervision
- Dosing Frequency: Oral: once daily; Injection: once monthly
- Bioavailability: Oral: 5–40%; Injection: provides sustained release
- Half-life: Oral: 4–13 hours; Injection: 5–10 days
- Metabolism: Primarily hepatic, via dihydrodiol dehydrogenase
- Excretion: Primarily renal (urine)
Benefits
- Reduces alcohol cravings by blocking opioid-mediated reward pathways in the brain
- Decreases the frequency of heavy drinking episodes and supports sustained abstinence
- Helps break the cycle of alcohol dependence by diminishing the pleasurable effects of drinking
- Non-addictive and does not cause withdrawal symptoms upon discontinuation
- Compatible with comprehensive AUD treatment programs including therapy and support groups
- Available in both daily oral and monthly injectable forms to suit individual patient needs and adherence preferences
Common use
Naltrexone is commonly prescribed for individuals diagnosed with alcohol use disorder who are motivated to reduce or stop alcohol consumption. It is used in adults as part of a broader treatment strategy that often includes cognitive behavioral therapy (CBT), motivational enhancement therapy, and participation in support groups such as Alcoholics Anonymous (AA) or SMART Recovery. The medication is suitable for patients who have undergone detoxification and are in the early stages of abstinence or are seeking to prevent relapse. It may also be used off-label in certain cases of impulse control disorders, though its primary and approved indication remains the management of AUD.
Dosage and direction
Oral Tablets: The typical recommended dose for alcohol dependence is 50 mg once daily, with or without food. Treatment should be initiated after the patient has achieved opioid-free status for at least 7–10 days to avoid precipitating withdrawal. The tablet should be taken whole with water; it may be taken in the morning or evening based on patient preference and side effect profile.
Extended-Release Injection: Administered by a healthcare professional as a gluteal intramuscular injection once every 4 weeks or once monthly. The dose is 380 mg delivered via a specialized needle into the muscle. Rotation of injection sites (left and right gluteal muscles) is recommended for subsequent doses.
Dosage adjustments may be necessary for patients with hepatic impairment. Treatment duration is individualized but often continues for 3–6 months or longer based on clinical response and patient progress.
Precautions
- Naltrexone may cause hepatocellular injury when given in excessive doses. Liver function tests (LFTs) are recommended before initiation and periodically during treatment.
- Patients should be opioid-free before starting naltrexone to avoid precipitated withdrawal. A naloxone challenge test may be considered in cases of suspected opioid use.
- Use with caution in patients with renal impairment; dosage adjustment may be required.
- Depressive and suicidal ideation have been reported; monitor patients for emergence or worsening of depression.
- Avoid use in acute hepatitis or liver failure.
- Inform patients that naltrexone will block the effects of opioid analgesics. In emergency situations, non-opioid analgesics or general anesthesia will be required.
- Patients should carry medical identification indicating they are on naltrexone therapy.
Contraindications
- Patients receiving opioid analgesics, currently dependent on opioids, or in acute opioid withdrawal.
- Patients with acute hepatitis or liver failure.
- History of hypersensitivity to naltrexone or any component of the formulation.
- For the injectable form: allergy to polylactide-co-glycolide (PLG) or carboxymethylcellulose sodium.
- Failure to pass a naloxone challenge test or having a positive urine screen for opioids.
Possible side effect
Common side effects (≥5% incidence) include:
- Nausea (10%)
- Headache (7%)
- Dizziness (4–10%)
- Fatigue (4–10%)
- Insomnia (3–7%)
- Anxiety (2–5%)
- Injection site reactions (e.g., pain, induration, swelling, tenderness) for the extended-release formulation
Less common but serious side effects may include:
- Hepatotoxicity (elevated transaminases)
- Suicidal ideation or behavior
- Eosinophilic pneumonia (with injection)
- Severe injection site reactions including necrosis
- Depression
- Hallucinations
Most side effects are mild to moderate and tend to diminish within a few days to weeks of continued therapy.
Drug interaction
- Opioids: Naltrexone blocks the effects of opioid agonists, including analgesic, euphoric, and supportive effects.
- Opioid-containing medications: Avoid use with cough suppressants, antidiarrheals, and some pain medications.
- Medications with hepatotoxic potential: Acetaminophen, NSAIDs, anticonvulsants—monitor LFTs closely.
- Thioridazine: May cause lethargy and somnolence.
- Disulfiram: Concurrent use may increase risk of hepatotoxicity.
- CYP450 enzymes: Naltrexone is a minor substrate of CYP3A4; interactions with strong inducers/inhibitors are possible but not well-documented.
Missed dose
For oral tablets: If a dose is missed, take it as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a missed one.
For monthly injection: Contact the healthcare provider to reschedule the injection as soon as possible. Do not attempt self-administration.
Overdose
There is no specific antidote for naltrexone overdose. Symptoms may include nausea, abdominal pain, drowsiness, and dizziness. In cases of suspected overdose, seek immediate medical attention. Supportive care should be provided, including monitoring of vital signs and symptomatic treatment. Hemodialysis is not expected to enhance elimination. In the event of accidental ingestion by an opioid-dependent individual, severe opioid withdrawal may occur and require management.
Storage
- Store at controlled room temperature (20–25°C or 68–77°F); excursions permitted between 15–30°C (59–86°F).
- Keep in the original container, tightly closed, and protected from moisture.
- Keep out of reach of children and pets.
- Do not freeze.
- For the injectable suspension: must be administered immediately after reconstitution; discard any unused portion.
Disclaimer
This information is intended for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Do not disregard professional medical advice or delay in seeking it because of something you have read in this product card. Naltrexone is a prescription medication and should only be used under the supervision of a licensed healthcare provider.
Reviews
Clinical studies and patient reports consistently support the efficacy of naltrexone in reducing alcohol consumption:
- “In a 12-week double-blind study, naltrexone significantly reduced relapse rates and alcohol craving compared to placebo.” – Journal of the American Medical Association
- “Monthly injectable naltrexone improved abstinence rates and was associated with high patient satisfaction due to improved adherence.” – American Journal of Psychiatry
- Patient testimonial: “Naltrexone helped take away the constant urge to drink. I didn’t feel high when I drank—it just lost its appeal. Combined with therapy, it gave me my life back.”
Individual results may vary. Always consult with a healthcare professional to determine if naltrexone is appropriate for your situation.