Suboxone has had a tremendously positive impact on opioid addiction recovery. It has a much lower potential for illicit use than other medications for opioid use disorder (MOUD). It also makes it harder to get high on other opioids. When people who currently use or formerly used opioids take Suboxone without a prescription, it’s usually to prevent withdrawal symptoms. So why is this medication still highly regulated?
Opioids and people who use them were major targets of the war on drugs. In the 1970s and ’80s, this campaign criminalized opioid use. It also created a negative image that persists today. It shaped public policy and influenced both public and professional opinions about opioid use. As a result, many users received punishment instead of treatment. The impact was especially devastating to Black and low-income communities. Today, medical experts and care providers recognize opioid use disorder (OUD) as a health condition. It’s not a choice or a moral failing.
Suboxone is classified as a Schedule III drug by the Drug Enforcement Agency (DEA). When Suboxone was first introduced, there were many limits to access and use. As of recently, more care providers are allowed to prescribe Suboxone so they can help people recover from OUD. Access is increasing, but there are still significant barriers for many people.
In this blog post, we’ll talk about why Suboxone is a Schedule III drug and what this means.
Why is Suboxone a controlled substance?
Suboxone is a controlled substance because it has both medical uses and potential for “misuse.” Misuse means taking medication not as prescribed or using it without a prescription. However, the perceived potential for misusing Suboxone is clouded by the long history of stigma and criminalization associated with opioids.
Compared to other MOUD, Suboxone is very safe. It has a lower potential for nonprescription use by those who are dependent on opioids. People who aren’t already taking other opioids may use Suboxone to get high, though this is uncommon. Its effects are much milder than other opioids, including methadone.
What is a Schedule III controlled substance?
By definition, Schedule III substances have a recognized medical use and also carry some potential for misuse. They’re considered to have a lower potential for misuse compared to Schedule I and II substances, which is why Suboxone is a safe treatment for OUD despite historical stigma and strict regulation. The government passed the Controlled Substances Act (CSA) in 1970. It groups drugs together based on laws that apply to them. This may not always reflect clinical data or the opinions of medical professionals. For instance, drugs can be scheduled by an act of Congress. There are more detailed processes that enable government agencies to schedule drugs as well.
The goal of this system is to regulate the production, distribution, and use of drugs seen as high risk or dangerous. It protects people who take potentially addictive medication for medical purposes. Prescribers must be aware of each medication’s potential for misuse and exercise appropriate caution to prevent overprescribing or duplicate prescriptions. In some cases, they need a DEA license to prescribe certain medications. The CSA penalizes unregulated production and distribution of potentially addictive medications. It’s also a major reason why some people are punished for drug use and addiction. The government considered opioids to be a major threat to public well-being when these laws were created. Any medication with a potential for illicit use is still treated with suspicion. They can only be prescribed by health care providers who have a DEA license.
What’s the history of the approval and regulation of Suboxone?
Suboxone was approved by the FDA for OUD treatment in 2002. Researchers had identified the active ingredient, buprenorphine, as a potential solution for OUD recovery more than 30 years prior. However, there were several barriers to approval for this purpose. Again, stigma and potential for misuse worried policymakers and drug manufacturers.
Even after Suboxone was approved, few prescribers had the certification to prescribe it. To prescribe the active ingredient buprenorphine for OUD, they needed to complete special training and sign an X-waiver. This discouraged many from offering this treatment. Those who received training had strict limits on the number of patients they could treat at one time. It also fed into the stigma that painted opioids and recreational users as dangerous. As of 2023, qualified providers no longer need an X-waiver to prescribe Suboxone.
In 2018, the SUPPORT for Patients and Communities Act further increased access to Suboxone. This law allows physician’s assistants, nurse practitioners, and other care providers to prescribe it. It also increased the number of patients that certain qualified prescribers can treat for OUD.
What are the risks and benefits of Suboxone treatment?
Suboxone reduces cravings and withdrawal symptoms during recovery from OUD. As mentioned, it has a lower potential for misuse than other options like methadone. This is partly because buprenorphine has a ceiling effect. This means that higher doses don’t cause increased euphoria or an increased risk of death by overdose. It also blocks the effects of other opioids, making it harder to get high in general. Suboxone also includes naloxone, known as Narcan. It works much differently in Suboxone than the emergency overdose reversal medication. Its dose is lower and it’s intended to discourage people from misusing their medication. The ingredient is inactive unless a person injects or snorts their medication or takes another type of opioid. When this happens, the naloxone triggers precipitated withdrawal symptoms.
Suboxone can cause some side effects. People can stop breathing when taking Suboxone, though the risk is low when taken in therapeutic doses because of the ceiling effect. Combining Suboxone with benzodiazepines or other respiratory depressants may cause overdose, so people who take these medications should tell their prescriber about their other prescriptions and the dosage they’re taking.
Some potential side effects of Suboxone include:
- Headache
- Sweating
- Nausea
- Vomiting
- Constipation
- Swelling in arms and legs
- Insomnia
- Mouth or tongue numbness, burning, and redness if you use the orally dissolvable film
At Groups, we believe people who use opioids deserve the same dignity and respect as everyone else. There is no right or wrong path to recovery, only what works best for you. When people have the knowledge, resources, and support they need, they’re more likely to achieve their recovery goals.
Our treatment program combines three types of treatment for a comprehensive approach. Members receive access to MOUD, one-on-one counseling, and support from their peers. We don’t shame people for using, and we won’t kick members out if they get off track from their goals.
Are you looking for access to Suboxone treatment? We can help. Give our Recovery Support Specialists a call today for more information or to begin your recovery.
If Groups doesn’t offer treatment in your state, you can locate other treatment options here.