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
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
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
- sleeping difficulties
- 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.
can be done if they are?
8. What are the key components of the risk-management plan?
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.
The main components of the risk-management plan are preventive measures
Preventive Measures include:
- 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
- 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.
- 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.
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?
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