Basic Suboxone Information
Here is some general information about Suboxone from the Food and Drug Administration.
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.
The FDA approved 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.
Suboxone is the formulation used in the majority of patients.
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 provides more patients the opportunity to access treatment.
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.
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.
Both medications come in 2 mg and 8 mg strengths as sublingual (placed under the tongue to dissolve) tablets.
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.
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 and surveillance.
Preventive Measures include:
- tailored distribution
- Schedule III control under the Controlled Substances Act (CSA)
- child resistant packaging
- supervised dose induction
- 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.
- 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.
The NIH announced results from first large scale study on treatment of prescription opioid addiction in 2011.
("Painkiller Abuse Treated by Sustained Buprenorphine/Naloxone. NIH. http://nih.gov/news/health/nov2011/nida-08a.htm. November 8, 2011)
People addicted to prescription painkillers reduce their opioid abuse when given sustained treatment with the medication buprenorphine plus naloxone (Suboxone), according to research published in the Archives of General Psychiatry and conducted by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health.
The study, which was the first randomized large scale clinical trial using a medication for the treatment of prescription opioid abuse, also showed that the addition of intensive opioid dependence counseling provided no added benefit.
"The study suggests that patients addicted to prescription opioid painkillers can be effectively treated in primary care settings using Suboxone," said NIDA Director Nora D. Volkow, M.D. "However, once the medication was discontinued, patients had a high rate of relapse — so, more research is needed to determine how to sustain recovery among patients addicted to opioid medications."
Pain medications are beneficial when used as prescribed, but they have significant abuse liability, especially when taken for non-medical reasons. This study examined whether the FDA-approved medication Suboxone could help combat this growing problem.
Suboxone is a combination of buprenorphine to reduce opioid craving plus naloxone, which causes withdrawal symptoms in someone addicted to opioids if Suboxone were taken by a route other than orally, as prescribed. This combination was specifically designed to prevent abuse and diversion of buprenorphine and was one of the first to be eligible for prescribing under the Drug Addiction Treatment Act, which permits specially trained physicians to prescribe certain FDA approved medications for the treatment of opioid addiction.
According to the Substance Abuse and Mental Health Services Administration's National Survey on Drug Use and Health, an estimated 1.9 million people in the United States meet abuse or dependence criteria for prescription pain relievers. In addition, the Centers for Disease Control and Prevention report that annually, more people die from prescription painkiller overdoses than from heroin and cocaine combined.
Suboxone just prevents withdrawal symptoms. It does nothing to help a person stop craving the high of opiate abuse, or desiring the oblivion of the opiate euphoria. The only way to stop the desire to abuse drugs is with honest and effective drug rehabilitation.
(Narconon International. http://www.narconon.org/drug-abuse/effects-of-suboxone.html 2014)
According to market research firm Wolters Kluwer, in 2011, sales of Suboxone in the U.S. exceeded $1.3 billion dollars and continues to steadily grow.
Dangers of Using Suboxone
There is no major risk of overdose for people who take Suboxone for medium-to-long-term maintenance, as long as the drug is used as prescribed. The problem with treating an opiate addiction with an opiate is that patients must then be weaned from the replacement drug.
Research continues into the use, effectiveness and dangers associated with Suboxone as deaths have been reported in patients using the drug. These deaths are generally the result of improper or illegal use of the drug. But, the risk of severe negative effects, including overdose, is higher if the patient does not receive enough buprenorphine and continues to take other drugs.
Suboxone overdose can be fatal, particularly if the patient injects this drug while also taking sedatives, tranquilizers or alcohol. Unconsciousness, severe respiratory depression and death can occur. Life-threatening overdose also can result from taking excessive amounts of Suboxone orally or combining oral Suboxone with alcohol, sedatives, tranquilizers, certain antidepressants and other opioid medications.
Opponents argue that it should have been more controlled and blame the FDA and the NIDA for allowing it to emerge on the streets. The system is imperfect, however, and any drug, no matter the control, can still get into the wrong hands and be used improperly.
The editors of CESAR FAX, a weekly update on substance abuse research, wrote, "While research indicates that buprenorphine is an effective drug for treating opioid dependence, we feel that the potential for its nonmedical use and related unintended consequences may be going unnoticed."
As buprenorphine is more widely prescribed, there may be increasing problems with diversion and misuse.
In the study, researchers at Brown University analyzed patterns of buprenorphine abuse by intravenous (IV) and non-IV opioid users in Providence, Rhode Island. They found that about three-fourths of these opioid users were obtaining buprenorphine-containing medications illicitly.
(Wolters Kluwer. Journal of Addiction Medicine.2012)
Suboxone is particularly attractive to recreational abusers because there is a built-in safety factor with pharmaceutical grade prescription drugs when compared to street drugs. Prescription drugs are manufactured in sterile environments with highly calibrated instruments that measure each dose to a finite amount and guarantee potency. Potency will not be less than stated, ensuring that abuser will not get “ripped-off”, and likewise, potency will not be greater than stated, thereby “mitigating” the risk of overdose. Such finite measurements also facilitate crushing and mixing of pills of different classes to enhance euphoric effects.
The euphoric effects of Suboxone are attractive to these adolescents who lack the developed tolerance for opiates which the experienced veteran abuser has. Suboxone is about 20-30 times more potent than morphine as an analgesic; and like morphine it produces dose-related euphoria, drug-liking, papillary constriction, respiratory depression and sedation. As noted above, it is also addictive.
Adolescent non-drug addicts can quite easily get “high” from a single Suboxone pill (the euphoric effect can be further enhanced by crushing and snorting the pill). In this group, experts predict a future generation of addiction-challenged individuals as their tolerance and experiences increase and their needs are met by increased intake or by combining with different classes of drugs or alcohol.
Doctors are permitted to prescribe as many as 30 take-home pills per visit, so federal regulators now acknowledge that some users seem to be injecting the crushed tablets to get high, that there exists a thriving street market for the drug and that certain doctors seem to be prescribing the drugs outside of the bounds of good medical practices.
Dr. Charles R. Schuster, former director of NIDA, explains that, "A small minority of doctors are not practicing good medicine." He contends that although it may be legal for a doctor to prescribe a full 30 day supply after a first visit, it is neither expedient nor good care, and contends that doctors should get to know patients prior to prescribing full dosage quantities.
("Getting High on Suboxone? The FDA Says It's Happening - Ex NIDA Director Blames Doctors." http://www.choosehelp.com/news/addiction-treatment/getting-high-on-suboxone-the-fda-says-its-happening-ex-nida-director-blames-doctors.html. February 24, 2008)
Nationally, at least 1,350 of 12,780 buprenorphine doctors have been sanctioned for offenses that include excessive narcotics prescribing, insurance fraud, sexual misconduct and practicing medicine while impaired. Some have been suspended or arrested, leaving patients in the lurch.
In Ohio, 449 doctors were authorized to prescribe buprenorphine (2013), and around 16% had been disciplined.
The New York Times says the addiction drug was a “primary suspect” in 420 deaths in the United States reported to the Food and Drug Administration since it reached the market in 2003, according to a Times analysis of federal data.
But buprenorphine is not being monitored systematically enough to gauge the full scope of its misuse, some experts say. The Centers for Disease Control and Prevention does not track buprenorphine deaths, most medical examiners do not routinely test for it, and neither do most emergency rooms, prisons, jails and drug courts.
Still, Dr. John Mendelson of San Francisco, a consultant for the company that manufactures Suboxone (Reckitt Benckiser), said it could be proud of its management of a difficult product. “Their biggest success so far,” he said, “is that the whole system has not imploded, that enough doctors have prescribed the drug appropriately that there has been no move to withdraw it from the market.”
(Deborah Sontag. "Addiction Treatment With a Dark Side." http://www.nytimes.com/2013/11/17/health/in-demand-in-clinics-and-on-the-street-bupe-can-be-savior-or-menace.html?hpw&rref=us&_r=1& The New York Times. November 16, 2013)
The general consensus, however, is that even with a certain level of abuse, Suboxone therapy remains one of the most promising treatments for opiate addiction.
An estimated 2.5 million Americans were dependent on or abused opioids in 2012, mostly painkillers, although heroin dependence has skyrocketed, with the number of addicts doubling over a decade to 467,000, government data indicate. In 2010, the last year studied, 19,154 people died of opioid overdoses.
“Had buprenorphine never been released and all we had was methadone, that number would be much higher,” said Dr. Andrew Kolodny, the president of Physicians for Responsible Opioid Prescribing.