Subutex is a brand-name version of buprenorphine that was prescribed as a Medication for Addiction Treatment (MAT) in the U.S. until 2011. It is available by prescription in other countries.
Generic forms of buprenorphine are available in the U.S., but most MAT programs prescribe Suboxone or a generic combination of buprenorphine and naloxone instead.
Subutex is a sublingual tablet that eases withdrawal symptoms in people who are overcoming opioid use disorder.
Subutex: What Is It & What Was It Used For?
Subutex is one of the first brand-name formulas of buprenorphine as a MAT. Buprenorphine is a partial opioid agonist that binds to the brain’s opioid receptors for several hours, providing long-lasting relief from pain or withdrawal symptoms.
Subutex contains only buprenorphine as the active ingredient, in contrast to the more familiar Suboxone, which contains both buprenorphine and naloxone. The naloxone renders Suboxone less easily abusable than Subutex, but Subutex was not removed from the market due to safety or efficacy problems.
Buprenorphine is a partial agonist at the opioid receptor and has a ceiling effect. This makes it safer than other opioids, because it has a lower risk of leading to overdose and death if taken in excessive quantities. It is a safe and effective medication commonly used for outpatient treatment of opioid use disorder (OUD).
Although physicians need to undergo specific training to prescribe buprenorphine-based drugs, they do not need to manage a clinic dedicated only to opioid addiction treatment, as is necessary for the prescription of methadone for opioid use disorder, for example. This makes buprenorphine based treatments more accessible for people struggling to overcome an opioid problem.
Although Subutex is still available by prescription in many parts of the world, it is no longer available in the United States.
How Does Subutex Work?
Subutex comes in 0.4 mg, 2 mg, and 8 mg sublingual tablets. Sublingual means that the medication is placed under the tongue to dissolve. The medication enters the bloodstream quickly through the mucous membrane in the mouth, so it binds to receptors in the brain in about an hour.
Your doctor will give you specific information on how to take your dose of Subutex, so your treatment is personalized to your needs. In general, however, you can expect this process when you take Subutex:
- Place your dose beneath your tongue.
- Allow the tablet to dissolve for 5 to 10 minutes.
- If you struggle with the taste of the tablet or feel your mouth is dry or chalky after the medication dissolves, you can sip water before taking Subutex. You may also swish water in your mouth after taking it, if the medicine has fully dissolved.
- Do not chew, swallow, or otherwise tamper with Subutex tablets, as they will not work.
- Do not eat, drink, or smoke cigarettes for 15 minutes before and after taking Subutex.
- Avoid alcohol while taking Subutex.
Most people will take Subutex once per day, but your physician may prescribe that you take it every other day or schedule smaller doses twice per day. Buprenorphine is active in your body for at least 12 hours, so you should experience full-day relief from cravings and withdrawal symptoms.
If you forget to take Subutex, take your dose as soon as you remember it. If you forget to take it for a full day, do not “double up” to replace your missed dose. Just take one dose as normal.
If you experience withdrawal symptoms after missing a dose, talk to your prescribing physician to see if they recommend taking a partial dose or finding another way to manage the sensations.
Potential Subutex Side Effects
Like all medications, there are some potential side effects associated with Subutex. They may include the following:
- Mild withdrawal symptoms, which you should report to your physician
- Agitation or restlessness
- Excessive sweating
- Muscle or joint discomfort
- Physical pain
If your pain is serious, let your doctor know, as there could be an underlying issue. Since buprenorphine can alleviate pain, taking it may mask pain associated with other conditions that need different medical treatment. Be sure to discuss this with your general practitioner and determine if you have any risk factors for other diseases or health issues.
You may experience sudden low blood pressure, which may make you feel dizzy if you stand up from sitting or lying down. Dizziness and sleepiness from taking Subutex can also impair driving.
More serious side effects include liver damage, although this is more frequently associated with people who already have liver damage due to alcohol abuse, prescription medications that can damage the liver, or hepatitis C infection. Buprenorphine can interact with this underlying condition and make it worse.
Severe side effects from Subutex are very rare. They may include the following:
- Trouble urinating
- Skin reactions
If you have any symptoms of an allergic reaction, call 911 for help immediately. Then, inform your physician as soon as possible. Allergic reactions are very serious and warrant emergency medical attention. You will need to immediately stop taking Subutex.
Recently, the U.S. Food and Drug Administration (FDA) announced that dental problems had been associated with medications like Subutex or Suboxone, which are dissolved in the mouth. Visit your dentist at least once per year, and let them know that you take Subutex, so they can monitor for signs of tooth decay, gum disease, or other dental issues. The risk of dental issues can be mitigated with proper oral hygiene.
Can You Get Subutex in the US?
Subutex is not available by prescription in the United States, as of 2011. The pharmaceutical manufacturer, Reckitt Benckiser Pharmaceuticals, Inc., discontinued production for the U.S. market after concerns were raised about the potential for diversion, misuse, and abuse of buprenorphine medications.
Generic buprenorphine is still regularly prescribed in the U.S. While combinations of buprenorphine and naloxone like Suboxone are more popular as MAT, buprenorphine sublingual or buccal (cheek-dissolving) tablets and films are also prescribed to manage chronic pain.
Bicycle Health provides Suboxone therapy for opioid use disorder. Bicycle offers educational resources on Belbuca, Subutex and Sublocade, but does not currently offer those therapies.
Medically Reviewed By Claire Wilcox, MD
Claire Wilcox, MD, is a general and addiction psychiatrist in private practice and an associate professor of translational neuroscience at the Mind Research Network in New Mexico; and has completed an addictions fellowship, psychiatry residency, and internal ... Read More
- Highlights of Prescribing Information: Subutex. Access Data FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020732s018lbl.pdf. February 2018. Accessed February 2022.
- Buprenorphine. Substance Abuse and Mental Health Services Administration (SAMHSA). https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/buprenorphine. January 2022. February 2022.
- Package Leaflet: Information for the User. Medicines UK. https://www.medicines.org.uk/emc/files/pil.4088.pdf. October 2020. Accessed February 2022.
- Buprenorphine Sublingual and Buccal (opioid dependence). MedlinePlus. https://medlineplus.gov/druginfo/meds/a605002.html. December 2020. Accessed February 2022.
- FDA Warns About Dental Problems with Buprenorphine Medicines Dissolved in the Mouth to Treat Opioid Use Disorder and Pain. U.S. Food and Drug Administration (FDA). https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-dental-problems-buprenorphine-medicines-dissolved-mouth-treat-opioid-use-disorder. January 2022. Accessed February 2022.
- Why Was Subutex Discontinued? Drugs.com. https://www.drugs.com/medical-answers/subutex-discontinued-3558340/. May 2021. Accessed February 2022.