Suboxone.com - SUBOXONE Certification

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IMPORTANT INFORMATION:

On December 8, 2006, Federal legislation was passed allowing physicians to treat up to 100 opioid dependent patients with Suboxone at any given time—a significant increase from the previous limit of 30 patients.

There may be doctors in your area participating in a study to measure opioid dependence treatment outcomes. Patients who meet the eligibility requirements to participate in this study can receive up to $225 in compensation to complete surveys about their treatment.

NOTE: This study is only open to patients not currently under the care of a physician for opioid dependence and are seeking a treatment provider.

Please call 1-866-455-8876 between 9:00 AM to 7:30 PM EST to get more information.

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Prescribing Information -- Site Map

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Learn how to be listed as a Suboxone prescriber

IMPORTANT INFORMATION

After holding certification for at least 1 year (30 patient limit), physicians may submit a second notification to treat up to 100 patients. For complete second notification information, go to www.buprenorphine.samhsa.gov

SUBOXONE Certification

In October 2000, treatment of opioid dependence was transformed by Congressional approval of the Drug Addiction Treatment Act (DATA 2000).

Under DATA 2000, qualified physicians may obtain a waiver allowing them to prescribe and/or dispense approved Schedule III-V medications for the treatment of opioid dependence. Previously, this type of treatment was available only in federally approved Opioid Treatment Programs, namely, methadone clinics.

For the first time in more than 30 years, qualifying physicians have the legal right to use approved opioid medications (eg, SUBOXONE) to treat opioid dependence in the privacy of an office-based setting.

To become certified to prescribe SUBOXONE for office-based treatment of opioid dependence (ie, to receive a DATA 2000 waiver), physicians must complete 2 steps:

1.	Prove that they are qualified
2.	Notify the Substance Abuse and Mental Health Services Administration (SAMHSA) of their intent to treat patients with SUBOXONE

For second notifications:

Use this link to access a blank form (PDF).
Use this link to access a form pre-filled with information from your original waiver notification (HTML).

SAMHSA/CSAT will formally acknowledge your submission of the second notification by letter; however, unless you are notified of the contrary, the "good faith" submission of the second notification permits treatment of up to 100 patients.

Home -- About SUBOXONE -- Treating Opioid Dependence -- SUBOXONE Certification -- Pharmacists -- Resources

Important Safety Information

SUBOXONE® (buprenorphine HCl/naloxone HCl dihydrate sublingual tablets) (CIII) is indicated for the treatment of opioid dependence.

It is extremely dangerous to take benzodiazepines or other depressants while taking SUBOXONE. A serious overdose and death may occur if benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol are taken at the same time as SUBOXONE.

SUBOXONE has potential for abuse and produces dependence of the opioid type, with a milder withdrawal syndrome than full agonists.

Cytolytic hepatitis and hepatitis with jaundice have been observed in the addicted population receiving buprenorphine.

Allergic reactions including bronchospasm, angioneurotic edema, and anaphylactic shock have been reported in patients taking buprenorphine.

There are no adequate and well-controlled studies of SUBOXONE (a Category C medication) in pregnancy.

Caution should be exercised when driving cars or operating machinery.

Always store buprenorphine-containing medications safely and out of the reach and sight of children. Destroy any unused medication appropriately.

The most commonly reported adverse events with SUBOXONE include: headache (36%, placebo 22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), insomnia (14%, placebo 16%), nausea (15%, placebo 11%), and constipation (12%, placebo 3%). Please see full Prescribing Information for a complete list.

To report an adverse event caused by taking SUBOXONE, please call 1-877-782-6966. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.