Subutex & Suboxone: Questions and Answers

Subutex vs. Suboxone

1. What are Suboxone and Subutex?

Subutex and Suboxone are medications approved for the treatment of opiate dependence. Both medicines contain the active ingredient, buprenorphine hydrochloride, which works to reduce the symptoms of opiate addiction.

2. Why did the FDA approve two medications?

Subutex contains only buprenorphine hydrochloride. This formulation was developed as the initial product. The second medication, Suboxone contains an additional ingredient called naloxone to guard against misuse.

Subutex is given during the first few days of treatment, while Suboxone is used during the maintenance phase of treatment.

3. Will most prescriptions be for the Suboxone formulation?

Yes, Suboxone is the formulation used in the majority of Suboxone detox patients.

4. How are Subutex and Suboxone different from the current treatment options for opiate dependence such as methadone?

Currently opiate dependence treatments like methadone can be dispensed only in a limited number of clinics that specialize in addiction treatment. There are not enough addiction treatment centers to help all patients seeking treatment. Subutex and Suboxone are the first narcotic drugs available under the Drug Abuse Treatment Act (DATA) of 2000 for the treatment of opiate addiction that can be prescribed in a doctor’s office. This change will provide more patients the opportunity to access treatment.

5. What are some possible side effects of Subutex and Suboxone?

(This is NOT a complete list of side effects reported with Suboxone and Subutex. Refer to the package insert for a more complete list of side effects.)

The most common reported side effect of Subutex and Suboxone include:

• cold or flu-like symptoms
• headaches
• sweating
• sleeping difficulties
• nausea
• mood swings

Like other opioids Subutex and Suboxone have been associated with respiratory depression (difficulty breathing) especially when combined with other depressants.

6. Are patients able to take home supplies of these medicines?

Yes. Subutex and Suboxone are less tightly controlled than methadone because they have a lower potential for abuse and are less dangerous in an overdose. As patients progress on therapy, their doctor may write a prescription for a take-home supply of the medication.

7. How will FDA know if these drugs are being misused, and what can be done if they are?

FDA has worked with the manufacturer, Reckitt-Benckiser, and other agencies to develop an in-depth risk-management plan. FDA will receive quarterly reports from the comprehensive surveillance program. This should permit early detection of any problems. Regulations can be enacted for tighter control of buprenorphine treatment if it is clear that it is being widely diverted and misused.

8. What are the key components of the risk-management plan?

The main components of the risk-management plan are preventive measures and surveillance. Preventive Measures include:

• education
• tailored distribution
• Schedule III control under the Controlled Substances Act (CSA)
• child resistant packaging
• supervised dose induction

The risk management plan uses many different surveillance approaches. Some active methods include plans to:

• Conduct interviews with drug abusers entering treatment programs.
• Monitor local drug markets and drug using network areas where these medicines are most likely to be used and possibly abused.
• Examine web sites.

Additionally data collection sources can indicate whether Subutex and/or Suboxone are implicated in abuse or fatalities. These include:

• DAWN —The Drug Abuse Warning Network. This is run by the Substance Abuse and Mental Health Services Administration (SAMHSA) which publishes a collection of data on emergency department episodes related to the use of illegal drugs or non-medical use of a legal drug.
• CEWG —Community Epidemiology Working Group. This working group has agreed to monitor buprenorphine use.
• NIDA —National Institute of Drug Abuse. NIDA will send a letter to their doctors telling them to be aware of the potential for abuse and to report it if necessary.

9. Who can prescribe Subutex and Suboxone?

Only qualified doctors with the necessary DEA (Drug Enforcement Agency) identification number are able to start in-office treatment and provide prescriptions for ongoing medication for Subutex and Suboxone detox. CSAT (Center for Substance Abuse Treatment) will maintain a database to help patients locate qualified doctors.

10. How will Subutex and Suboxone be supplied?

Both medications come in 2 mg and 8 mg strengths as sublingual (placed under the tongue to dissolve) tablets.

11. Where can patients get Subutex and Suboxone?

These medications will be available in most commercial pharmacies. Qualified doctors with the necessary DEA identification numbers will be encouraged to help patients locate pharmacies that can fill prescriptions for Subutex and Suboxone detox.

For more detailed information on Buprenorphine please see the following:
Buprenorphine

At The Pat Moore Foundation Subutex and Suboxone detox treatments occur in a safe, comfortable, home-like environment that is a crucial element for the client’s state of mind. During this process they are still able to participate in counseling sessions with their case manager and group therapy with their peers, contingent on their physical well-being. To learn more about treatment, pricing and outpatient services, please click on the appropriate word.

If the individuals require further medical attention, Costa Mesa and the Newport Beach area have renowned hospitals within a few minutes of this facility.

Many issues come up in early sobriety that can be difficult to handle. The staff at Pat Moore Foundation is on call 24-hours and understands this, and is eager to help at any time of the day or night. Our goal is to enable each person who enters our doors walk the road to a healthy and happy recovery.

Pat Moore Foundation's drug & alcohol detox and alcohol & drug addiction treatment programs are licensed and certified by The State of California. We provide non-medical and medically managed detoxification (using Suboxone, Subutex, and Buprenorphine when appropriate) and primary residential treatment. Our individual homes are on a unique co-ed campus where we offer gender specific treatment. We are located in Costa Mesa, in Orange County, Southern California, close to Newport Beach and Huntington Beach, and only an hour's drive from Los Angeles and San Diego. To speak with a counselor, please call us 24-hours at (888) 426-6086 or if you'd like us to contact you, send a confidential message online by filling out our online form.

Note: All medical services are administered by medical professionals, which are facilitated and operated solely under the jurisdiction of a separate medical corporation.

Source: U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment, see http://www.fda.gov/cder/drug/infopage/subutex_suboxone/subutex-qa.htm.