What is Zubsolv®?

Zubsolv is a brand-name prescription medication that’s used to treat opioid dependence in adults. Opioid dependence is now called opioid use disorder by healthcare professionals. Zubsolv is meant to be used in combination with other forms of treatment, such as behavioral therapy or counseling.

Zubsolv contains two active drugs: buprenorphine and naloxone. It comes as a sublingual tablet, which dissolves when it’s placed under your tongue.

Zubsolv was approved by the Food and Drug Administration (FDA) based on how similar it is to another drug called Suboxone. Suboxone also contains buprenorphine and naloxone, and it’s also used to treat opioid dependence. However, Suboxone comes as a film you take by mouth.

The FDA found that Zubsolv provides similar blood levels of buprenorphine as Suboxone provides. The combination of buprenorphine and naloxone is recommended as an effective treatment option in current treatment guidelines.

In clinical studies, Zubsolv was tested in people with opioid dependence. The drug was found effective for three days of treatment. By the third day of treatment, 85% to 93% of people taking Zubsolv were still in treatment. Of people taking the generic form of buprenorphine, 92% to 95% were still in treatment.

As stated above, Zubsolv contains buprenorphine and naloxone.

Buprenorphine is a partial agonist at the mu-opioid receptor and a weak antagonist at the kappa-opioid receptor. Partial agonism at the mu-opioid receptor causes a plateau for analgesia at higher doses, at which point it begins to act as an antagonist. This also causes a ceiling effect for respiratory depression.

Buprenorphine’s role in Zubsolv is to prevent withdrawal symptoms and reduce cravings by providing typical opioid agonist effects, but with a ceiling effect. Because it is a partial agonist, buprenorphine can reduce the pleasurable effects of other opioids that may be taken with it.

Naloxone is a competitive antagonist with high affinity for the mu-opioid receptor, causing it to reverse the effects of opioids already bound to these receptors. This activity is only seen if it is administered parenterally or intranasally, but not orally or sublingually (as in the case of Zubsolv). Naloxone’s role in Zubsolv is as an abuse deterrent.

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Important Safety Information

If I take Zubsolv, will I become addicted to the drug?

It’s possible that you can become dependent on Zubsolv, but it’s unlikely that you’ll become addicted to the drug.

Physical dependency is different from addiction. When someone is physically dependent on a drug, their body needs to keep taking that drug in order to feel normal. Being dependent on a drug doesn’t necessarily mean that the drug causes bad outcomes in your life.

Addiction is a disease in your brain’s reward pathways. This disease leads someone to continue using a drug even though it is causing serious problems in their life. Over time, someone with addiction needs more and more of a drug to feel its effects. They may engage in risky behavior in order to keep taking the drug.

Zubsolv is used to treat physical dependency on opioids. While Zubsolv contains an opioid (called buprenorphine), it’s much less likely to make someone feel “high” or cause addiction-like behaviors. When taken as directed by your doctor, it will help prevent opioid cravings and opioid withdrawal symptoms.

If you’re concerned about the effects of Zubsolv treatment, talk with your doctor before you start taking the drug.

Zubsolv precautions

Before taking Zubsolv, talk with your doctor about your health history. Zubsolv may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

Breathing problems. Zubsolv can cause respiratory depression (slow and weak breathing). This condition can prevent your brain and other organs from getting enough oxygen. If you have breathing problems such as COPD or other lung conditions, you may have a higher risk for life-threatening respiratory depression. Talk with your doctor to find out if Zubsolv is safe for you.
History of serious allergic reaction. You shouldn’t take Zubsolv if you’ve had a serious allergic reaction to either buprenorphine or naloxone, the two active drugs in Zubsolv. If you’re unsure whether you’ve had a serious allergic reaction to either drug, talk with your doctor before you take Zubsolv.
Liver damage or liver disease. You shouldn’t take Zubsolv if you have severe liver damage or liver disease. This is because your liver clears naloxone (one of the active drugs in Zubsolv) out of your body. If your liver isn’t working properly, naloxone won’t be cleared from your body quickly enough. This can lead to high levels of naloxone and an increased risk of opioid withdrawal symptoms. Buprenorphine (one of the active drugs in Zubsolv) can also cause serious liver problems, such as hepatitis. Zubsolv may not be right for people with moderate liver damage or liver disease either. Talk with your doctor about your liver health to find out if Zubsolv is safe for you.
Head injury or brain tissue damage. Buprenorphine (one of the active drugs in Zubsolv) can increase pressure inside of your head. This can cause serious and permanent brain damage. If you have a history of head injury or brain tissue damage, talk to your doctor about whether Zubsolv is safe for you.
Bile duct damage or bile duct disease. Buprenorphine (one of the active drugs in Zubsolv) can increase pressure in your bile duct tract (an area of your body that includes your liver, gallbladder, and bile ducts). If you have bile duct damage or bile duct disease, talk to your doctor about whether Zubsolv is safe for you.
Intestinal damage or intestinal disease. Buprenorphine (one of the active drugs in Zubsolv) can have intestinal side effects, especially constipation. These side effects in your intestines can make it harder for your healthcare providers to treat intestinal damage or intestinal disease. If you have intestinal conditions, talk with your doctor about whether Zubsolv is safe for you.
Pregnancy. All opioids, including the buprenorphine contained in Zubsolv, can cause neonatal opioid withdrawal syndrome (NOWS). With this syndrome, babies who are born to mothers who took opioids during their pregnancy have opioid withdrawal symptoms. For more information, please see the “Zubsolv and pregnancy” section above.

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