The Discontinuation of a Brand Name
The brand name Subutex was officially discontinued by its manufacturer in 2011 [1.3.1, 1.3.5]. The primary reason for this decision was the development and promotion of a formulation considered to be safer: Suboxone [1.3.2]. Subutex contained only one active ingredient, buprenorphine, which is a partial opioid agonist. While effective for managing opioid withdrawal and cravings, its formulation as a single-ingredient tablet raised concerns about potential misuse, such as crushing and injecting the medication [1.3.1, 1.3.4].
To address these concerns, Suboxone was created. It combines buprenorphine with another medication called naloxone [1.5.1]. Naloxone is an opioid antagonist, meaning it blocks the effects of opioids. When Suboxone is taken as prescribed (dissolved under the tongue), the naloxone has minimal effect because it is poorly absorbed [1.9.4]. However, if someone attempts to inject the medication, the naloxone becomes active and can trigger immediate and unpleasant withdrawal symptoms [1.9.1, 1.9.4]. This mechanism acts as a significant deterrent to misuse [1.3.2]. Although the Subutex brand is gone, the FDA declared in 2015 that it was not withdrawn for safety or effectiveness reasons, which permitted other companies to produce generic versions of buprenorphine-only tablets [1.3.3].
Understanding Buprenorphine: The Active Ingredient
Buprenorphine is a semi-synthetic opioid used to treat opioid use disorder (OUD), as well as acute and chronic pain [1.2.4]. As a partial opioid agonist, it binds to and activates opioid receptors in the brain but to a lesser degree than full agonists like heroin, fentanyl, or methadone [1.7.1, 1.7.4]. This action is key to its effectiveness in treatment:
- Reduces Cravings and Withdrawal: By partially activating opioid receptors, buprenorphine alleviates the physical symptoms of withdrawal and reduces cravings, allowing individuals to focus on their recovery [1.7.1, 1.7.3].
- Blocks Other Opioids: Buprenorphine binds very strongly to opioid receptors. This high affinity means it can block other opioids, like heroin, from binding and producing a high [1.5.3].
- Ceiling Effect: Unlike full agonists, buprenorphine has a "ceiling effect." This means that beyond a certain dose, its opioid effects plateau, which lowers the risk of respiratory depression and overdose compared to other opioids [1.7.3, 1.2.4].
Buprenorphine is a Schedule III controlled substance in the United States, indicating it has accepted medical use but also a potential for misuse and dependence [1.2.4].
Modern Alternatives: Suboxone and Other Formulations
Today, patients seeking treatment have several options. The most common medication prescribed for at-home use is Suboxone or its generic equivalents [1.3.2]. However, buprenorphine-only (monotherapy) products, often still colloquially called "Subutex," are used in specific situations [1.3.2].
- During Pregnancy: Buprenorphine monotherapy has historically been preferred for pregnant patients, although recent studies suggest Suboxone is also safe [1.5.4, 1.3.2].
- Allergy to Naloxone: In rare cases where a patient is allergic to naloxone, a buprenorphine-only product is necessary [1.3.2].
- Initial Detox: Some clinicians may start a patient on a buprenorphine-only product during the initial, highly supervised phase of detoxification before transitioning them to a combination product for long-term maintenance [1.2.3, 1.3.2].
Beyond sublingual (under the tongue) tablets and films, buprenorphine is available in other forms:
- Injectables: Extended-release injections like Sublocade (monthly) and Brixadi (weekly or monthly) provide a steady dose of medication [1.4.2].
- Buccal Films: Belbuca is a film placed on the inside of the cheek for pain management [1.4.2].
- Transdermal Patches: Butrans is a patch applied to the skin for the treatment of severe pain [1.4.2].
Comparison: Subutex (Generic) vs. Suboxone
| Feature | Generic Buprenorphine (like Subutex) | Suboxone |
|---|---|---|
| Active Ingredients | Buprenorphine only [1.3.2] | Buprenorphine and Naloxone [1.3.2] |
| Misuse Deterrent | No [1.3.2] | Yes (Naloxone) [1.3.2] |
| Common Use Case | Supervised detox, pregnancy, naloxone allergy [1.3.2] | Long-term outpatient maintenance [1.3.2] |
| Formulations | Sublingual tablets [1.3.2] | Sublingual films or tablets [1.5.5, 1.3.2] |
| Availability | Generic available [1.3.3] | Brand and generic available [1.3.3] |
Common Side Effects
As with any medication, buprenorphine can cause side effects. Common ones include:
- Headache [1.8.1, 1.8.3]
- Nausea and vomiting [1.8.1, 1.8.2]
- Constipation [1.8.2]
- Drowsiness [1.8.1]
- Sweating [1.8.1]
- Mouth numbness or irritation [1.8.4]
- Trouble sleeping [1.8.1]
More serious side effects can occur, including dental problems, liver issues, respiratory depression (especially when mixed with other depressants like alcohol or benzodiazepines), and physical dependence [1.8.3, 1.7.1]. It is crucial to take the medication exactly as prescribed and maintain regular contact with a healthcare provider.
Conclusion
To answer the question, "What is Subutex called now?", the brand name itself is no longer on the market [1.3.1]. It has been largely replaced by the safer formulation, Suboxone, which includes naloxone to deter misuse [1.3.2]. However, the core of what Subutex was—a buprenorphine-only medication—still exists in the form of generic buprenorphine tablets. These are prescribed in specific clinical situations, but for most people undergoing medication-assisted treatment for opioid use disorder, a combination product like Suboxone is the current standard of care [1.3.2].
Disclaimer: This article is for informational purposes only and does not constitute medical advice. Consult with a qualified healthcare professional for diagnosis and treatment. An authoritative source for locating treatment is the SAMHSA Treatment Locator.
