Naltrexone Vs. Suboxone: Drug Comparison

Naltrexone is the active ingredient in the brand-name medication Vivitrol^®. The information below is about brand name Vivitrol. According to the FDA, “Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines.”

Vivitrol (naltrexone) is an extended-release injectable medication used to treat alcohol dependence and prevent relapse in individuals with opioid dependence after detoxification. It works by blocking opioid receptors in the brain, reducing cravings and the effects of alcohol and opioids, making relapse less likely. Its FDA-approved indications include the treatment of alcohol use disorder and as part of a comprehensive treatment plan for opioid dependence that includes psychosocial support. Vivitrol is administered as a once-monthly intramuscular injection. Common side effects include nausea, vomiting, dizziness, decreased appetite, and injection site reactions, while serious risks include liver damage and precipitated opioid withdrawal. Caution is advised for patients with liver disease or those who have recently used opioids, as sudden withdrawal symptoms can occur.

Suboxone^® is a combination of buprenorphine and naloxone used to treat opioid dependence by reducing withdrawal symptoms and cravings while discouraging misuse. Buprenorphine is a partial opioid agonist that helps ease opioid withdrawal and cravings, while naloxone is an opioid antagonist that prevents misuse by causing withdrawal if injected. Its FDA-approved indication is for the treatment of opioid dependence, usually as part of a comprehensive treatment program that includes counseling and psychosocial support. Suboxone is available as a sublingual film or tablet taken daily. Common side effects include headache, nausea, sweating, and constipation, and it carries a warning for the risk of respiratory depression, misuse, and dependence, especially when used with central nervous system (CNS) depressants such as alcohol or benzodiazepines.

Opioid antagonist

Buprenorphine: partial‐opioid agonist

Naloxone: opioid antagonist

Vivitrol (naltrexone) is indicated:

• For the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol. Patients should not be actively drinking at the time of initial Vivitrol administration

• For the prevention of relapse to opioid dependence, following opioid detoxification

Vivitrol should be part of a comprehensive management program that includes psychosocial support

Suboxone (buprenorphine hydrochloride and naloxone hydcrochloride) is indicated:

• For treatment of opioid dependence

Suboxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support

• Typically administered as an injection by a healthcare provider once monthly

• Comes as an injectable suspension containing 380 mg of naltrexone in a microsphere formulation in a single-dose vial

• Typically taken as a sublingual film once daily

• Comes in 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg sublingual films

The adverse events seen most frequently in association with Vivitrol therapy for alcohol dependence (i.e, those occurring in ≥5% and at least twice as frequently with Vivitrol than placebo) include:

• Nausea

• Vomiting

• Injection site reactions (including induration, itchiness, nodules, and swelling)

• Muscle cramps

• Dizziness or fainting

• Sleepiness or sedation

• Anorexia

• Decreased appetite or other appetite disorders

The adverse events seen most frequently in association with Vivitrol therapy in opioid-dependent patients (i.e., those occurring in ≥2% of patients treated with Vivitrol and at least twice as frequently with Vivitrol than placebo) were:

• Liver enzyme abnormalities

• Injection site pain

• Inflammation of the nose and throat

• Insomnia

• Toothache

Adverse events commonly observed with the sublingual/buccal administration of the Suboxone sublingual film are:

• Oral loss of sensation

• Pain in the tongue

• Oral mucosal redness

• Headache

• Nausea

• Vomiting

• Excessive sweating

• Constipation

• Signs and symptoms of withdrawal

• Insomnia

• Pain

• Swelling of the extremities

• Patients receiving opioid analgesics

• Patients with current physiologic opioid dependence

• Patients in acute opioid withdrawal

• Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids

• Patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent

• Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations, and opioid analgesics

• Hypersensitivity to buprenorphine or naloxone

• Drug interactions: benzodiazepines, CYP3A4 inhibitors and inducers, antiretrovirals, serotonergic drugs

• Vulnerability to opioid overdose

• Injection site reactions

• Precipitation of opioid withdrawal

• Liver toxicity

• Depression and suicidality

• When reversal of Vivitrol blockade is required for pain management: In an emergency situation in patients receiving Vivitrol, suggestions for pain management include regional analgesia or use of non-opioid analgesics

• Eosinophilic pneumonia

• Hypersensitivity reactions including anaphylaxis

• Addiction, abuse, and misuse

• Respiratory depression

• Unintentional pediatric exposure

• Neonatal opioid withdrawal syndrome

• Adrenal insufficiency

• Risk of opioid withdrawal with abrupt discontinuation

• Risk of hepatitis, hepatic events

• Precipitation of opioid withdrawal signs and symptoms

• Risk of overdose in opioid‐naïve patients

• Breastfeeding: Buprenorphine passes into mother's milk

*This information is from the label for brand name Vivitrol^®. See the Full Prescribing Information for more complete information. Naltrexone, the active ingredient in Vivitrol, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient naltrexone.

*This information is from the label for brand name Suboxone^®. See the Full Prescribing Information for more complete information. Buprenorphine and naloxone, the active ingredients in Suboxone, may also be the active ingredients in other medications, and this information may not be accurate for all medications that include the active ingredients buprenorphine and naloxone.