An advanced formulation for the treatment of opioid dependence
ZUBSOLV (buprenorphine and naloxone) sublingual tablets (CIII)
- ZUBSOLV is a medication for adults with opioid dependence
- ZUBSOLV should be used as part of a complete treatment plan that also includes counseling and behavioral therapy
ZUBSOLV® delivers a comparable concentration of active medication to previously approved Suboxone® tablets.1
But ZUBSOLV is different—in a study of 758 people with opioid dependence who experienced both ZUBSOLV and Suboxone film, more than 70% of patients preferred the attributes of ZUBSOLV overall:2
- Menthol taste
- Ease of administration
Only your healthcare provider can prescribe ZUBSOLV. See the full study results.
1. Fischer A, Jönsson M, Hjelmström P. Pharmaceutical and pharmacokinetic characterization of a novel sublingual buprenorphine/naloxone tablet formulation in healthy volunteers. Drug Dev Ind Pharm. 2013;1-6. DOI: 10.3109/03639045.2013.846365.
2. Data on file. Orexo US, Inc.
What is ZUBSOLV®?
ZUBSOLV® (buprenorphine and naloxone) sublingual tablet (CIII) is a prescription medicine used to treat adults who are addicted to opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
IMPORTANT SAFETY INFORMATION
Do not take ZUBSOLV if you are allergic to buprenorphine or naloxone as serious negative side effects, including anaphylactic shock, have been reported.
ZUBSOLV can cause serious and life-threatening breathing problems. Call your healthcare provider right away or get emergency help if (a) you feel faint, dizzy, or confused; (b) your breathing gets much slower than is normal for you; (c) you feel sleepy and uncoordinated; (d) you have blurred vision; (e) you have slurred speech; (f) you cannot think well or clearly; or (g) you have slowed reflexes and breathing. In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with ZUBSOLV.
ZUBSOLV contains buprenorphine, an opioid that can cause physical dependence with chronic use. Physical dependence is not the same as addiction. Your healthcare provider can tell you more about the difference between physical dependence and addiction. Do not stop taking ZUBSOLV without talking to your healthcare provider. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
Your healthcare provider may monitor liver function before and during treatment with ZUBSOLV.
Keep ZUBSOLV in a secure place away from children. If a child accidentally takes ZUBSOLV, this is a medical emergency and can result in death. Get emergency help right away.
The most common side effects of ZUBSOLV include: headache, drug withdrawal syndrome, nausea, decrease in sleep (insomnia), vomiting, pain, increased sweating, swelling of the extremities, and constipation. Tell your healthcare provider about any side effect that bothers you or that does not go away.
Do not switch from ZUBSOLV to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of ZUBSOLV is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of buprenorphine that may be different than other buprenorphine-containing medicines you may have been taking.
ZUBSOLV is not for occasional or “as needed” use. An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using ZUBSOLV. Ask your healthcare provider what you should do if you are taking one of these. You should not drink alcohol while taking ZUBSOLV, as this can lead to loss of consciousness or even death.
Do not inject (“shoot-up”) ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections and other serious health problems. Injecting ZUBSOLV may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
Before taking ZUBSOLV, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before taking ZUBSOLV, tell your healthcare provider if you are pregnant or plan to become pregnant. If you take ZUBSOLV while pregnant, your baby may have signs of withdrawal at birth and that withdrawal is treatable. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
Before taking ZUBSOLV, tell your healthcare provider if you are breastfeeding or plan to breastfeed. ZUBSOLV can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take ZUBSOLV. Monitor your baby for increased sleepiness and breathing problems.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how ZUBSOLV affects you. Buprenorphine can cause drowsiness and slow reaction times. This may happen more often in the first few weeks of treatment when your dose is being changed, but can also happen if you drink alcohol or take other sedative drugs when you take ZUBSOLV.
ZUBSOLV is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your ZUBSOLV in a safe place to protect it from theft. Never give your ZUBSOLV to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.
This is not a complete list of negative side effects associated with ZUBSOLV. For a complete list please see full Prescribing Information.
To report negative side effects associated with taking ZUBSOLV, please call 1-888-982-7658. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.