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The Drug Addiction Treatment Act of 2000 (DATA 2000) enables healthcare providers who meet specific qualifications to prescribe ZUBSOLV® (buprenorphine and naloxone) CIII.

This is not a comprehensive list. The healthcare providers included here are part of a publicly available database from the Substance Abuse and Mental Health Services Administration (SAMHSA) or are healthcare providers who have chosen to be a part of the zubsolv.com healthcare provider locator program. This does not include all healthcare providers who are waivered.

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INFORMATION PROVIDED/VERIFIED BY HEALTHCARE PROVIDER

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Terms and Conditions

All eligible healthcare providers, who are waivered under DATA 2000, are invited to participate in the Orexo US, Inc. Find a Healthcare Provider locator. There is no fee or cost for your participation in or use of the locator. Qualifying criteria are listed below:

  • You must be waivered under DATA 2000, and continue to comply with its rules and regulations
  • Your medical license must be active and in good standing
  • You must have a unique identifier, issued by the Drug Enforcement Administration (DEA) that is active and in good standing, and that shows you are waivered under DATA 2000
  • You have agreed to these Terms and Conditions and have agreed to participate in writing on the downloadable Agreement
  • You agree that if, at any time, you no longer meet all the qualifying criteria it is your responsibility to notify Orexo immediately, in writing, so that Orexo may remove your name from the Find a Healthcare Provider locator

You also acknowledge that Orexo US, Inc. does not track prescription volume or value based on referrals through its Find a Healthcare Provider locator.

You may request to be removed from the Find a Healthcare Provider locator and Orexo US, Inc. retains the right to remove healthcare providers from the Find a Healthcare Provider locator for any of the following reasons:

  • Your contact information is no longer valid
  • Your DATA 2000 waiver or medical license is suspended, revoked, or restricted
  • Your are not in compliance with DATA 2000 and its implementing regulations
  • Orexo US, Inc. has information or determines that you may be engaging in the unsafe prescribing of our product(s)

Limitation of Orexo US, Inc. Liabilities: This Find a Healthcare Provider locator is compiled for informational purposes only. No fees have been or will be paid or received in exchange for participation in this locator. In no event shall Orexo US, Inc. or its employees or agents be liable for any damages resulting from or related to the Find a Healthcare Provider locator. All providers and other users of this information agree that the use of this locator is at their own risk.

Orexo US, Inc. is not responsible for the medical care or advice given by any participating healthcare provider. Inclusion in the Orexo US, Inc. Find a Healthcare Provider locator does not represent an endorsement, referral, or recommendation from Orexo US, Inc. Moreover, participating in this locator does not endorse the use of any Orexo US, Inc. product(s).

ZUBSOLV is a licensed trademark of Orexo US, Inc.

Indication

ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is indicated for the treatment of opioid dependence. ZUBSOLV should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Treatment should be initiated under the direction of healthcare providers who meet certain qualifying requirements under the Drug Addiction Treatment Act of 2000, and who have been assigned a unique identification number (“X” number).

IMPORTANT SAFETY INFORMATION

Contraindications

  • ZUBSOLV is contraindicated in patients with a history of hypersensitivity to buprenorphine or naloxone, as serious adverse reactions, including anaphylactic shock, have been reported.

Warnings and Precautions

  • Addiction, Abuse, and Misuse: Buprenorphine can be abused in a similar manner to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Multiple refills should not be prescribed early in treatment or without appropriate patient follow-up visits.

  • Respiratory Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Warn patients of the potential danger of self-administration of benzodiazepines or other CNS depressants while under treatment with ZUBSOLV.

  • Unintentional Pediatric Exposure: Store ZUBSOLV safely out of the sight and reach of children. Buprenorphine can cause severe, possibly fatal respiratory depression in children.

  • Neonatal Opioid Withdrawal Syndrome (NOWS): Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy.

  • Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patients off of the opioid.

  • Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately.

  • Risk of Hepatitis; Hepatic Events: Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events.

  • Precipitation of Opioid Withdrawal Signs and Symptoms: An opioid withdrawal syndrome is likely to occur with parenteral misuse of ZUBSOLV by individuals physically dependent on full opioid agonists or by sublingual administration before the agonist effects of other opioids have subsided.

  • Risk of Overdose in Opioid-Naïve Patients: ZUBSOLV is not appropriate as an analgesic. There have been reported deaths of opioid-naïve individuals who received a 2-mg sublingual dose of buprenorphine.

Use in Specific Populations

  • Lactation: Buprenorphine passes into mother’s milk.

  • Geriatric Patients: Monitor for sedation and respiratory depression.

  • Moderate and Severe Hepatic Impairment: Buprenorphine/naloxone products are not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment.

Adverse Reactions & Drug Interactions

  • Adverse events commonly observed with the sublingual administration of ZUBSOLV are headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.

  • Benzodiazepines: Use caution in prescribing ZUBSOLV for patients receiving benzodiazepines or other CNS depressants and warn patients against concomitant self-administration/misuse.

  • CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over or under dosing.

  • Antiretrovirals: Patients who are on chronic buprenorphine treatment should have their dose monitored if NNRTIs are added to their treatment regimen. Monitor patients taking buprenorphine and atazanavir with and without ritonavir, and reduce dose of buprenorphine if warranted.

  • Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue ZUBSOLV if serotonin syndrome is suspected.

This is not a complete list of potential adverse events associated with buprenorphine/naloxone sublingual tablets. Please see full Prescribing Information for a complete list.

To report an adverse event associated with taking ZUBSOLV sublingual tablet, please call 1-888-ZUBSOLV (1-888-982-7658). You are encouraged to report adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see accompanying full Prescribing Information and Medication Guide.