Evidence reviewed
United States
The FDA has approved oral naltrexone tablets and Vivitrol, a 380 mg extended-release injection. Oral products have multiple generics. Coverage and out-of-pocket cost depend on the exact product, diagnosis, plan, pharmacy or medical benefit, and prior-authorization rules.
The United States was the first country to approve naltrexone — the FDA granted approval in 1984 for opioid dependence and extended it to alcohol dependence in 1994. Today, naltrexone is available in two forms: daily oral tablets (50 mg generic, sold under brand names including ReVia and Depade historically) and monthly extended-release injection (Vivitrol, 380 mg, manufactured by Alkermes).
Coverage depends on the exact plan and whether a product is billed through a pharmacy or medical benefit. A formulary listing is not the same as zero out-of-pocket cost; prior authorization, site-of-care rules, deductibles, and eligibility for assistance can all matter.
The current FDA Vivitrol label was revised in December 2025. It tells clinicians to discuss and strongly consider prescribing an opioid-overdose reversal agent, while emphasizing the risks of precipitated withdrawal, attempts to overcome blockade, and overdose after treatment is interrupted or stopped.
Multiple pathways depending on your insurance and treatment goals.
Your regular doctor can prescribe oral naltrexone (generic 50 mg tablets). No specialist referral is required. This is the simplest and fastest pathway — often same-day prescription. Generic tablets cost $25–$100/month without insurance, far less with coverage.
For complex cases or if you want Vivitrol (the monthly injection), a specialist referral is common. Addiction medicine physicians and psychiatrists can manage both oral and injectable naltrexone. Vivitrol must be administered by a healthcare professional — it cannot be self-injected.
Federally certified opioid treatment programmes can provide Vivitrol as part of comprehensive medication-assisted treatment. Many OTPs receive federal grant funding that reduces patient costs. These programmes also provide counselling and psychosocial support.
Naltrexone can be prescribed via telehealth in most states. Online platforms connect you with licensed physicians who can assess your needs and prescribe oral naltrexone. Vivitrol requires in-person administration even if the consultation is virtual.
Do not rely on national coverage percentages for an individual claim.
Check the current formulary, prior authorization, deductible, site-of-care rule, and whether Vivitrol is billed under the medical or pharmacy benefit. Manufacturer assistance has eligibility and savings limits.
Rules are state-specific. Ask the state plan or managed-care plan about the exact NDC/J-code, indication, prior authorization, preferred alternatives, and administration fee.
Coverage may involve Part D or a medical benefit depending on product and setting. Manufacturer copay cards generally exclude federal health-program beneficiaries; verify with the plan.
Request separate written prices for medicine, clinician visit, laboratory work, and injection administration. Ask federally qualified health centers and official patient-assistance programs about eligibility.
Product and label facts checked 26 July 2026.
Initial US approval for opioid dependence
Oral naltrexone approval expanded to alcohol dependence
Extended-release intramuscular injection every 4 weeks
FDA label date for Vivitrol safety information
Yes. The FDA labelling states that patients should not be actively drinking at the time of initial Vivitrol administration and should be able to abstain from alcohol in an outpatient setting. For opioid dependence, you must be opioid-free for a minimum of 7–10 days (longer if transitioning from buprenorphine or methadone — up to 2 weeks). A naloxone challenge test or negative urine opioid screen is required.
Oral naltrexone prescribed for alcohol dependence is covered by most insurance plans regardless of the dosing protocol. Your doctor writes the prescription for naltrexone — the indication is alcohol dependence, not the Sinclair Method. Whether you take it daily or as-needed is between you and your doctor. Insurance covers the medication, not the protocol.
The FDA approved a Teva generic extended-release injectable naltrexone application in 2023, but FDA records list it as discontinued and it is not currently marketed. In practical terms, branded Vivitrol remains the marketed US monthly injection; oral tablets have multiple generics.
Yes. The Veterans Health Administration (VA) covers both oral naltrexone and Vivitrol for eligible veterans as part of substance use disorder treatment. Your VA primary care provider or mental health clinician can prescribe it. Coverage is comprehensive and typically involves minimal or no copay for service-connected veterans.
Oral naltrexone is a 50 mg tablet taken daily. It blocks opioid receptors for 24–48 hours. Vivitrol is a 380 mg extended-release injection given once monthly into the gluteal muscle by a healthcare provider. It provides continuous receptor blockade for approximately 28–30 days. The main clinical advantage of Vivitrol is adherence — no daily pill to remember. The main disadvantage is cost and the need for in-person administration.
Telehealth prescribing rules vary by state and are evolving. During the COVID-19 public health emergency, many restrictions were relaxed. As of 2026, most states allow telehealth prescribing of non-controlled medications like oral naltrexone. Vivitrol must be administered in person regardless of how the prescription was written. Check your specific state's telehealth regulations.
Start with your primary care doctor or search for an addiction medicine specialist near you. If cost is a barrier, the Vivitrol Co-pay Savings Program and patient assistance programmes can help.
