Frequently Asked Questions

We gain strength and courage and confidence by each experience in which we really stop to look fear in the face.  We must do that which we cannot!  --Joan Adams

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.

Suboxone is supplied by either a tablet or film.

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 or strips depending on which form of the medication is prescribed by your provider.

      These medications are 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.

    11. Where can I go for more information?

    12. Where can patients get 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.

    13.  Why do I have to feel sick to start the medication for it to work the best? 

              When you take your first dose  of  Suboxone,  if   you 
              already  have  high levels  of  another  opioid  in your
              system, the Suboxone will compete with those opioid
              molecules  and  replace  them  at  the  receptor  sites.
              Because Suboxone has milder opioid effects than full
              agonist  opioids,   you  may  go  into  a  rapid  opioid 
              withdrawal  and   sick,  a  condition   which  is  called  
              "precipitated  withdrawal."  By  already being in mild 
              moderate  withdrawal when you take your first dose
              of   Suboxone,  the  medication  will  make  you feel 
              noticeably better, not worse. 

    14.  How does Suboxone work?

    Suboxone  binds  to  the same receptors  as  other opioid drugs. It mimics the effects of other opioids by alleviating cravings  and  withdrawal  symptoms.  This allows you to address the psychosocial reasons behind your opioid use. 

    15.  When will I start to feel better?  

    Most patients feel a measurable improvement by thirty
    minutes, with  the  full  effects  clearly  noticeable after
    about one hour. 

    16.  How long will Suboxone last?

    After the first hour, many people say they feel pretty good for most of the day.  Responses to Suboxone will vary based on factors such as tolerance and metabolism, so each patient's dosing is individualized.  Your doctor may increase your dose of Suboxone during the first week to help keep you from feeling sick.  

    17.  Can I go to work right after my first dose?

    Suboxone can cause drowsiness and slow reaction time.  These responses are more likely over the first few weeks of treatment, when your dose is being adjusted.  During this time, your ability to drive, operate machinery, and play sports maybe affected.  Some people go to work right after their first Suboxone dose; however, many people prefer to take the first and possibly the second day off until they feel better.

    If you are concerned about missing work, talk with your physician about possible ways to minimize the possibility of your taking time off (eg, scheduling your Induction on a Friday or Saturday). 

    18.  Is it important to take my medication at the same time each day?

    Yes, in order to keep a steady supply of Suboxone in your system it is recommended you take your medication at the same time each day. Taking Suboxone once daily also helps the addicts get out of the routine of taking opiates throughout the day as they did while in active addiction.

    19.  If I have more than one tablet or film, do I need to take them together at the same time?

    Yes and no-you do need to take your dose at one "sitting," but you do not necessarily need to fit all tablets or films under your tongue simultaneously.  Some people prefer totake their tablets this way because it's faster, but this may not be what works best for you.  The most important thing is to be sure to take the full daily dose you were prescribed, so that your body maintains constant levels of Suboxone. 

    20.  Why does SUBOXONE need to be placed under the tongue?

     
    There are two large veins under your tongue (you can see them with a mirror). Placing the medication under your tongue allows Suboxone to be absorbed quickly and safely through these veins as the tablet dissolves. If you chew or swallow your medication, it will not be correctly absorbed as it is extensively metabolized by the liver. Similarly, if the medication is not allowed to dissolve completely, you won't receive the full effect.


        

    21.  Why does it sometimes only take 5 minutes for Suboxone to dissolve and other times it takes much longer? 

    Generally, it takes about 5-10 minutes for a tablet/film to dissolve. However, other factors (eg, the moisture of your mouth) can effect that time. Drinking something before taking your medication is a good way to help the tablet dissolve more quickly.

    22.  Why can't I talk while the medication is dissolving under my tongue?

    When you talk, you move your tongue, which lets the undissolved SUBOXONE "leak" out from underneath, thereby preventing it from being absorbed by the two veins. Entertaining yourself by reading or watching television while your medication dissolves can help the time to pass more quickly.

    23.  If I forget to take my Suboxone for a day will I feel sick?

    SUBOXONE works best when taken every 24 hours; however, due to the long half life of Suboxone it may last longer than 24 hours, so you may not get sick. If you miss your dose, try to take it as soon as possible, unless it is almost time for your next dose. If it is almost time for your next dose, just skip the dose you forgot, and take next dose as prescribed. Do not take two doses at once unless directed to do so by your physician.
    In the future, the best way to help yourself remember to take your medication is to start taking it at the same time that you perform a routine, daily activity, such as when you get dressed in the morning. This way, the daily activity will start to serve as a reminder to take your SUBOXONE*.

    24.  What happens if I still feel sick after taking Suboxone for a while?

    There are some reasons why you may still feel sick. You may not be taking the medication correctly or the dose may not be right for you. It is important to tell your doctor if you still feel sick.

    25.  What happens if I take drugs and then take Suboxone?

    You will probably feel very sick and experience what is called a "precipitated withdrawal."SUBOXONE competes with other opioids and will displace those opioid molecules from the receptors. Because SUBOXONE has less opioid effects than full agonist opioids, you will go into withdrawal and feel sick.

    References: FDA/Buprenorphine Information

      

      Shame Is Not The Same As Guilt

    When we feel guilt - It's about something we did.
    When we feel shame - It's about who we are.
    When we feel quilty
             -We need to learn that it is OK to make mistakes.
     When we feel shame
            -We need to learn that it is OK to be who we are.

    Written and Compiled:  Deborah Shrira    Dated: 7 September 2007

    Asst. Editor: Dee Black                 Updated: July 2012