Is Naltrexone a Controlled Substance?


Naltrexone is an opioid antagonist that’s not a controlled medication. According to the Controlled Substances Act, only substances with a high risk of misuse should be controlled, and naltrexone isn’t one of them as it doesn’t cause any mental or physical dependence.

This medication helps people with opioid addiction who try to get clean but struggle with withdrawal. It’s not a cure for drug and alcohol dependence but a part of the addiction treatment for opioid use disorders.

Is Naltrexone a Prescription Medication?

The American Food and Drug Administration approves Naltrexone as a part of the comprehensive treatment plan for drug and alcohol users. Although the risk of substance abuse is almost non-existent, only licensed physicians can prescribe naltrexone treatment for opioid use disorders.

Doctors suggest naltrexone along with cognitive-behavioral therapy and counseling. It’s important that the patients are clean from drugs, alcohol, and prescription painkillers, at least for a week for short-acting opioids or two weeks for long-acting opioids.

How Naltrexone Works

Naltrexone binds to the same opioid receptors as alcohol and drugs. It doesn’t trigger them the way opioids do but blocks them, so users can’t feel the euphoric and sedative effects of illicit substances. This medication keeps substance use disorder under control.

As an antagonist, naltrexone acts on opioid receptors to prevent drunkenness and a high feeling after taking illicit substances or alcohol. That should prevent withdrawal symptoms and opioid cravings.

Naltrexone Dosage Instructions

The dosage will depend on the patient’s condition, opioid medication form, and the type of opioid use disorder. Naltrexone comes in a pill form and as an extended-release injectable and can be used to treat opioid or alcohol use disorder.

Naltrexone pills usually carry 50 mg of the active substance, and patients usually take them in the morning to avoid missed dosage. Extended-release injectables contain 380 mg and are administered monthly.

For treating alcohol dependence, doctors usually prescribe 50 mg of naltrexone daily. The treatment usually lasts up to three months, depending on how patients react and whether any opioid withdrawal symptoms appear in the meantime.

In case of opioid addiction to drugs, painkillers, or tranquilizers, the starting dosage is 25 mg of naltrexone daily. If patients feel no withdrawal symptoms in the next few days, the dose increases to 50 mg.

Naltrexone Side Effects

Naltrexone is a safe treatment for drug and alcohol addiction, and the risk of relapse is minimal as it controls the patient’s urge to drink alcohol or use other opioids. However, people who face withdrawal, take painkillers, or any other drugs should inform their doctors to prevent interactions and adjust their therapy.

This opioid antagonist can trigger some side effects. Low doses can cause mild symptoms, like headache, runny nose, sleep issues, and nausea. These shouldn’t last long, and as the patient gets used to naltrexone, the side effect occurrence will be less frequent and shorter.

Severe side effects appear in rare cases, and they can be immediate or chronic. In the case of extended-release injectables, the injection site can swell, become tender or painful, in severe cases of adverse reaction, the surrounding tissue might die.

Patients with reduced tolerance to naltrexone can experience allergic symptoms. In a few cases, severe conditions like pneumonia, liver issues, depression, and suicidal thoughts can appear. In the case of existing medical conditions, life-threatening consequences of naltrexone treatment require urgent medical supervision.

Frequently Asked Questions

How Long Do Naltrexone Effects Last?

The effects of naltrexone depend on the administration method and dosage. In the case of its oral form, the effects will last from one to three days, depending on whether the patient has taken 50, 100, or 150 mg pill. Injectable naltrexone stays in the patient’s body for up to 28 days.

Does Naltrexone Cause Opioid Overdose?

Naltrexone prevents the effects of opioids, so people taking this medication can take more illicit substances to overcome this blockage. That carries the risk of opioid overdose. Also, it can happen that patients become more sensitive to opioids during this medication-assisted treatment.

Is Naltrexone Safe for Pregnant and Breastfeeding Women?

Taking naltrexone during pregnancy and the breastfeeding period isn’t recommended due to possible side effects and lack of evidence-supported studies conducted on humans.

To Sum Up

Naltrexone is a prescription medication that helps people overcome drug or alcohol use disorder. It’s not on the FDA’s list of controlled substances, but only certified physicians can prescribe medications for addiction treatment and keep the patient under supervision until the treatment is done.


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