What is Suboxone?
Suboxone comes in white, hexagonal shaped, sublingual tablets (i.e. to be dissolved under the tongue). Suboxone contains two active ingredients, buprenorphine and naloxone. Each tablet contains 2 mg of buprenorphine and 0.5 mg of naloxone or 8 mg of buprenorphine and 2 mg of naloxone.
What is Suboxone used for?
Suboxone is used by addicts who have agreed to seek treatment instead of the opioids they normally take. Opioids, also known as narcotics, are drugs such as heroin or morphine. Suboxone should be used for adults and young people over 15 years of age who have already been medically, socially and psychologically trained.
The medicine can only be obtained with a special prescription.
How is Suboxone used?
Suboxone should be used under the supervision of a physician experienced in the management of opioid addiction. Before prescribing the medicine, the patient's liver function should be assessed.
The method of use of Suboxone depends on the patient's condition, ie type of addiction, withdrawal status, any substitution therapy already in progress (eg methadone).
The recommended starting dose is one or two Suboxone 2 mg / 0.5 mg tablets, which will then be adjusted according to the patient's response until stabilized. The daily dosage should not exceed 24 mg of buprenorphine. Once the patient's condition has stabilized, the dosage schedule can be adapted or decreased. For complete dosing instructions please refer to the Summary of Product Characteristics included in the EPAR.
The tablets are placed under the tongue and left to dissolve; this happens in 5-10 minutes.
How does Suboxone work?
Suboxone contains two active substances: buprenorphine, an opioid agonist (a substance that acts like an opioid) and naloxone, an opioid antagonist (a substance that fights the effects of opioids). Buprenorphine, in sublingual tablet form, has been used on its own since the mid-1990s as a substitute treatment for opioid addiction.
However, it was found that the tablets were used improperly, as drug addicts dissolved them in order to inject the solution thus produced. In addition to buprenorphine, Suboxone also contains naloxone, which prevents the drug from being misused.When taken by mouth, naloxone is not absorbed, while if it is injected into an opioid-dependent patient it causes acute withdrawal symptoms.
How has Suboxone been studied?
The effects of Suboxone were first tested in experimental models before being studied in humans.
The main study on the efficacy of Suboxone compared Suboxone with buprenorphine given alone or with placebo (a dummy treatment) in 326 patients with opioid addiction (heroin addicts). The study lasted 4 weeks and measured the proportion of patients whose urine, at the end of the study, did not show traces of opioids. The patients also used a questionnaire specially designed to record the withdrawal crises, after which the change in the score obtained with the questionnaire was measured before the start and after the end of the study.
What benefit has Suboxone shown during the studies?
Suboxone was more effective than placebo: 17.8% of patients treated with the medicine tested negative in urinalysis at the end of the study, compared with 5.8% of patients treated with placebo. abstinence, ranging from 62.4 to 65.6 before treatment, fell to 29.8 after treatment with Suboxone (and to 55.1 with placebo). The study also indicated that there are no differences in efficacy between Suboxone and buprenorphine given alone.
What are the risks associated with Suboxone?
The most common side effects, seen in more than 1 in 10 patients, are insomnia, constipation, nausea, sweating, headache and withdrawal syndrome. For the full list of side effects reported with Suboxone, see the Package Leaflet.
Suboxone should not be used in patients who may be hypersensitive (allergic) to buprenorphine or naloxone or any of the other ingredients. It should also not be used in patients with severe pulmonary insufficiency, severe hepatic insufficiency or acute alcohol intoxication odelirium tremens (a condition induced by alcohol withdrawal).
Why has Suboxone been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that the combination of an opioid analogue substance and an opioid antagonist is an established strategy to reduce the possibility of substance abuse by injection into a vein, and therefore decided that the benefits of Suboxone as a replacement treatment for opioid addiction are greater than the risks, recommending the granting of a marketing authorization.
What are the measures taken to ensure the safe use of Suboxone?
The company that markets Suboxone will develop educational programs for doctors and pharmacists to make them aware of the risk of abuse and to report any specific safety concerns about the medicine, such as liver disorders and effects on infants.
More information about Suboxone
On September 26, 2006, the European Commission granted SP Europe a "Marketing Authorization" for Suboxone, valid throughout the European Union.
For the full version of the Suboxone evaluation (EPAR), click here.
Last update of this summary: 08- 2006.
Suboxone information published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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