Subutex and Suboxone: Questions and Answers By The FDA

Introduction By Terence T. Gorski: I have been receiving many questions about my opinion about the use of Suboxone and Subutex in the treatment of opiate addiction. I have mixed feelings, depending upon how it is used.

When Suboxone was originally developed as a joint effort between SAMHSA its subsidiary NIDA and Reckitt Benckiser Pharmaceuticals Inc. The motivations was to find a more effective maintenance medication for opiate addicts that could replace methadone maintenance and be administered and managed by physicians in their offices. Subutex and Suboxone are the first narcotic drugs available under the Drug Abuse Treatment Act (DATA) of 2000 for the treatment of opiate dependence that can be prescribed in a doctor’s office. This change will provide more patients the opportunity to access treatment.

Suboxone can be used as a part of multi-modality treatment, but it was developed to be a stand-alone treatment managed by physicians. With the implementation of the Affordable Care Act (ACA), Suboxone fits in perfectly with the government’s agenda to integrate addiction treatment into routine medical practice.

I am pleased to so the government recognize opiate addiction as a medical problem that requires treatment within the general health care system. I am disappointed that physicians are being trained to be the sole providers of Suboxone Treatment and that a comprehensive biopsychosocial assessment and multimodality treatment be strongly recommended or required as part of the treatment.

I have heard many reports from opiate addicts that Suboxone has helped them because it reduces or eliminates craving and does not produce a state of euphoria if it more is taken the prescribed. I might add, that most opiate addicts recovering with only Suboxone that  have talked to have experimented on “bad days” to see if they can get high by taking ore than prescribed. Most report that they can’t. Some, however, have had a relapse when they went out and get some other drug to get them through the bad period.

Subutex and Suboxone are also used a opiate detox medications in some programs.

I believe that any new medication that can help people addicted to opiates and other drugs is a good thing. It is short sighted, however, to build the use of any addiction medication around a purely medical model that does not encourage of require a brief course (about 90 days) of addiction counseling. This addiction-counseling program include:

(1) A biopsychosocial evaluation determines the severity of addiction and related problems

(2) Develops a sober social support to help patients to develop a new set of sober and responsible friends.

(3) Teaches life, a recovery, and relapse prevention skills;

(4) Helps to rebuild relationships on the job, at home, with extended family members, and friends.

These addiction-counseling programs can be delivered flexibly on an outpatient basis. Many addiction professionals offer services n ear many Suboxone Doctors and they could form a valuable collaboration for the benefit of the patient. It is also possible for Suboxone Doctors you include addiction professionals in the practice. This would expand services, increases patient retention, and add an additional revenue stream.

With these comments in mind, here are some of the FAQ questions about Suboxone on Subutex developed by NIDA.

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 dependence.

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 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 dependence 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. 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.

12.      Where can I go for more information?

Go to the Subutex/Suboxone webpage

Contact the CSAT Buprenorphine Information Center at 866-BUP-CSAT, or via email atinfo@buprenorphine.samhsa.gov or http://buprenorphine.samhsa.gov/

 

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25 Responses to Subutex and Suboxone: Questions and Answers By The FDA

  1. Guy Lamunyon says:

    Clients on these drugs continue both their physiological psychological addictions. When they have insisted on Suboxone I have advised if it doesn’t work your way we will try it my way next time. One young combat veterans was not so fortunate to make it back for a second trial – death due to overdosage. I prefer a DRUG FREE approach.

    • Terry Gorski says:

      Dear Guy, This is a tragic story of how when treatment fails addition can kill. s I said in the blog, I have mixed feelings about Suboxone, every similar to he feelings I have about methadone. As you said, the down side is that patients say physically dependent upon on opiate-like drug.I have seen Subxone used successfully for detoxification of long-term heavy-using opiate addicts. Long-term maintenance can be a transitional step to abstinence if it is accompanied by addiction counseling services. Unfortunately, Suboxone is usually viewed as something outside of the continuum of addiction treatment services. This creates the false belief that it is either Suboxone Treatment or Traditional Addiction Treatment. This false view is promoted by the Government in approving Suboxone Qualified Doctors without emphasizing the need to integrate Suboxone with other forms of addiction treatment.

      On the bright side, I have met many people who are treated with Suboxone for a year or more, and slowly developed the skills and the desire to brome drug free. I also believe that their are sever long-term opiate addicts who have such severe brain chemistry dysfunction that they experience severe anguish that does not seem to go away with long-term absence that takes away all quality of sobriety.

      I believe that abstinence with appropriate up-front detoxification needs to be the first line of treatment for most addicts. Long-term Suboxone Treatment should only be considered if abstinence-based treatment fails or if Suboxone or methadone maintenance is the only initial treatment a patient will accept. In my opinion, many doctors are too quick in using Suboxone maintenance because they don’t understand to appreciate the effectiveness of short-term Suboxone detox coupled with addiction treatment.

  2. inri13151 says:

    Terry/Guy,
    I have MOSTLY worked with the “DRUG FREE” approach ..yet I can see what Terry is bringing out in his detoxification…gradual dissapearenc of drug abuse by a more gentle withdrawel approach
    .
    .

    “I believe that any new medication that can help people addicted to opiates and other drugs is a good thing. It is short sighted, however, to build the use of any addiction medication around a purely medical model that does not encourage of require a brief course (about 90 days) of addiction counseling. This addiction-counseling program include”:

    I will add my ALWAYS LOGO..The ONLY LONG TERM APPROACH-
    LET GO LET GOD approach..

    I am still a HUGE “SURRENDER” fan

    Thanks to both Terry and Guy for being candid and effective in the HEALING PROCESS… we need ALL the assistance we can muster ..(anywhere and everywhere )…amen?
    Blessings to you both my well respected and admired brothers
    Your servant in Christ
    Steven J Taormina

  3. inri13151 says:

    Terry,
    Thanks EVER SO MUCH for all your research!
    (experiences and devotion)
    Steven

  4. dwamp says:

    Reblogged this on dwamp and commented:
    Great article !

  5. chucksigler says:

    My knee jerk reaction when I first heard that the treatment facility i worked for was permitting Suboxone patients was to say I’d quit. instead, i did some serious research and a paper titled: “Just a New Head for the Hydra of Opiate Addiction?” Here is an excerpt:

    The International Narcotics Control Board (INCB) 2006 annual report indicated that buprenorphine is one of the psychotropic medications most frequently diverted into the illicit drug market worldwide. Anecdotal evidence indicates that despite the cautions taken for dispensing buprenorphine, some maintenance patients manipulate their physicians in order to get high from buprenorphine. There is even a website to exchange information on how to get the most from your buprenorphine high.

    The only reasonable approach to this drug in addiction treatment, in my opinion, is as a medium or long term detoxification drug with treatment support. My thought is that post acute withdrawal is more protracted for buprenorphine users, making it more difficult for a person using it long term to successfully step down and stay abstinent.

    By the way, drugs.com lists Suboxone as the 39th best selling drug of the 4th quarter of 2013; making Reckitt Benckiser $1,403,762,000 in 2013.

    • Terry Gorski says:

      Drugs, both legal and illegal, are big business. The biggest revenue generators are the drugs that people need to take every day. It is a sad world — not so uch because companies sell drugs, but because people are so dumbed down they don’t research what they bare taking before they start taking it.

  6. Guy Lamunyon says:

    Opioid detoxification with mood stabilizers and antipsychotics, both in large doses can be accomplished in three days. Every time the addict wakes up they are given a prn and go back to sleep. At one place, we put the mattresses on the floor for these detox patients to prevent them from falling out of bed. After the three days the detox drugs are gradually withdrawn. The addicts wake up with mostly positive comments about the withdrawal procedure. This is much better than a six week gradual withdrawal on suboxone.

  7. Thanks for posting this Terry. I’m seeing that how successful Suboxone is depends on how it’s used. When used along with CBT and social support and being tapered correctly people benefit. When not used in this way people suffer.
    Onward & Upward
    Steve G.

  8. Along with the whole thing which appears to be building throughout this particular subject matter, all your perspectives are
    generally quite stimulating. On the other hand, I appologize, because I can not subscribe
    to your entire strategy, all be it radical none the less.
    It appears to me that your remarks are actually not completely justified and in simple fact you are generally your self not really totally confident of the point.
    In any event I did enjoy reading it.
    I do like the manner in which you have presented this particular

    • Terry Gorski says:

      Thank you for your opinion. If two people agree about everything, at least one of them is unnecessary. I am just sharing my best understanding at the time. I might be wrong.

      • inri13151 says:

        ” If two people agree about everything, at least one of them is”
        knowing …as Christ has said IF two or more are gathered in my name I am with you

        . Blessings brother Terry and thanks for gettingback-into the fray.. I do Hope that your health is much better and your feeling like your old self.. ( these posts are evidence) we have you back
        Your friend and willing servant
        Steven
        .

      • Terry Gorski says:

        Thank you. It is important to keep on keeping on and work at bouncing back. I will die when the Good Lord calls me. Until then, there is no retirement. spreading this knowledge is my mission. I don’t even know how to do much if anything else. I’ve never be one to stop midstream.
        A sponsor once told me: “You know when God is done with you — your heart is no longer beating.”

  9. erik0simmons says:

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    It is awesome information about heroin treatment..,

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  11. Kelli Kingston says:

    I have struggled with opiate and cocaine addiction for 32 years, here is my take on Suboxone.

    I used Suboxone as a miracle drug to avoid withdrawal symptoms for years. I went to the doctor, get my opiate scripts, and start taking Suboxone, 24mgs daily. Then I would use cocaine.

    I have kicked many different opiate drugs in my life-time, all of them in fact, Suboxone was the worst. Doctors play a tragic and dark joke on their patients when they prescribe it.

    It is irrational for an opiate addict who wants to get clean and sober to believe they can stop and feel no withdraw pain. The only way this is possible is to substitute the long-term use of another addictive opiate — like Suboxone. To think amy other way is to stat locked into denial and irrational beliefs about addiction. This addictive mindset, that a drug is the only thing that is going to make everything ok is, in my opinion, at the heart of addiction.

    I have been to detox over 17 times. I have experienced clean time also. The driving force that keeps me clean is remembering the pain and agony of the withdrawal process. If I forget what it was like to run out of my opiate of choice I am surely and without a doubt in DANGER of taking another one!!

    Kelli

    • Terry Gorski says:

      I believe that you are essentially correct. Suboxone may be useful to ease the pain of withdrawal. Without learning other recovery skills, however, the addiction comes back stronger than ever. An addictive drug cannot cure anyone from addiction to another addictive drug.
      Suboxone is very addictive for some people. Those who become addicted to it often reports that it is the worst addiction they ever experienced.

  12. barb b says:

    In 2009 the treatment center I work for instituted a Suboxone program (we closed that program about a year and a half later), we had a tight program, meeting the standards of care. Unfortunately, we found a huge diversion rate. Whether people get high, which patients have told me they have, or they are using it to keep from getting dope sick off the street, there is a market for it. Where there is a market, there is diversion. Patients told us that they only needed about 1/4 tab of 8 mg to keep from getting dope sick and for it to show up in the drug test (and not every day either). They would sell the rest. For these folks, figuring out what to show up with for a pill count is no problem….. Patients have told us, with a few exceptions, that Suboxone is the devil!!

  13. Davis Shryer says:

    What is troubling is that demand for prescribers outstrips the number of licensed physicians. This is because the MDs are limited to 100 patients total, making treatment limited in many areas. In Minneapolis, it is difficult to find available suboxone prescribers on short notice.

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      I am glad that the information is helpful. Please spread the word by reviewing or reposting the most helpful blogs. This is a grass roots effort and I need your help and support getting the word out. It makes a difference. Keep up the good work.

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