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.

Is Zubsolv a controlled substance?

Yes, Zubsolv is a controlled substance. It’s classified as a Schedule III prescription drug. This means that Zubsolv has an accepted medical use but may cause physical or psychological (mental) dependence. It’s possible for Zubsolv to be misused.

The Drug Enforcement Agency (DEA) has created special rules for how Schedule III drugs can be prescribed by a doctor and dispensed by a pharmacist. Your doctor or pharmacist can tell you more about these rules.

Doctors can only prescribe Zubsolv after they’ve had special training and have been certified by the U.S. federal government.

Effectiveness

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 opioid use disorder 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.

However, treatment for opioid dependence usually lasts longer than three days. The results of this study may not reflect what will happen over a usual course of treatment for opioid dependence.

The Zubsolv dosage your doctor prescribes will depend on several factors. These include:

  • the severity of the opioid dependence (opioid use disorder) you’re using Zubsolv to treat
  • the type of opioid (long-acting or short-acting) you’d been using before starting treatment for opioid dependence
  • whether you’re switching to Zubsolv from a different treatment for opioid use disorder
  • other medications you may be taking

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Zubsolv comes as a tablet that’s placed under your tongue (a sublingual tablet). After you’ve placed Zubsolv under your tongue, the tablet dissolves and releases its active drug ingredients.

Zubsolv contains two active drugs: buprenorphine and naloxone.

Zubsolv sublingual tablets are available in six strengths, which contain these amounts (in milligrams) of the drugs:

  • 0.7 mg of buprenorphine and 0.18 mg of naloxone
  • 1.4 mg of buprenorphine and 0.36 mg of naloxone
  • 2.9 mg of buprenorphine and 0.71 mg of naloxone
  • 5.7 mg of buprenorphine and 1.4 mg of naloxone
  • 8.6 mg of buprenorphine and 2.1 mg of naloxone
  • 11.4 mg of buprenorphine and 2.9 mg of naloxone

Dosage for opioid dependence

The usual dosage of Zubsolv is prescribed in two phases: the induction (beginning) phase and the maintenance (ongoing) phase.

You’ll begin Zubsolv treatment once you start having moderate opioid withdrawal symptoms. Your doctor will determine how severe your withdrawal symptoms are and will recommend when you should start taking Zubsolv.

You’ll take your first dose of Zubsolv at least six hours after you last took any opioids. Allowing this time to pass before you take Zubsolv will help prevent you from having severe opioid withdrawal symptoms.

Zubsolv is taken by placing the tablet under your tongue. If your doctor prescribes a dose that requires more than one tablet, you should take all your tablets at the same time. You’ll do this by placing the tablets in different areas underneath your tongue at one time. See “How to take Zubsolv” below for details.

Induction phase

During the induction phase, your doctor will prescribe your Zubsolv dosage based on several factors (see those factors listed above). You’ll take Zubsolv doses during this phase at a clinic or doctor’s office. This allows your doctor or another healthcare professional to monitor you after you’ve taken the drug and to treat any side effects if needed.

Your treatment during the induction phase depends on what type of opioids you had used prior to starting Zubsolv:

  • If you were dependent on short-acting opioids (such as heroin or immediate-release forms of morphine, hydrocodone, oxycodone, and hydromorphone):
    • You’ll start taking Zubsolv on day 1. Your maximum total dose on day 1 will be 5.7 mg buprenorphine and 1.4 mg naloxone. Zubsolv will be given to you in one to four doses over the course of the day. If your doctor prescribes more than one dose on day 1, you’ll likely take Zubsolv every 1.5 to 2 hours.
    • On day 2, your doctor will prescribe one dose of Zubsolv. The maximum dose on this day is 11.4 mg buprenorphine/2.9 mg naloxone.
  • If you were dependent on long-acting opioids (such as fentanyl, methadone, and extended-release forms of morphine, oxycodone, oxymorphone, and hydromorphone):
    • You might not start taking Zubsolv during the induction phase. Your doctor may prescribe a different drug for you to take during this phase.
    • Your treatment will typically be a drug that only contains buprenorphine and doesn’t contain naloxone. This is because long-acting opioids and methadone can stay in your body for a long time. Taking naloxone while these other drugs are still in your body can cause severe opioid withdrawal symptoms.

Maintenance phase

The maintenance phase of Zubsolv begins on day 3 of treatment. You will likely take your daily dose of Zubsolv at home during the maintenance phase.

In this phase, your doctor will prescribe the lowest dosage of Zubsolv that prevents your opioid withdrawal symptoms. Your starting dosage for this phase depends on how your body responded to treatment during the induction phase (days 1 and 2 of treatment).

The usual daily dosage range of Zubsolv is 2.9 mg buprenorphine/0.71 mg naloxone to 17.2 mg buprenorphine/4.2 mg naloxone. The recommended target dosage (the dosage that is most effective and causes acceptable side effects for the majority of people) is 11.4 mg buprenorphine/2.9 mg naloxone once a day.

However, your doctor will prescribe the dosage that’s best for you based on your treatment progress. They‘ll change your dosage according to your individual needs.

During the maintenance phase, your doctor will advise that you come into the office or clinic on a regular basis. Your appointments could be every day, every week, or every month, depending on what your doctor recommends. These appointments will allow your doctor to help you meet your treatment goals.

The length of the maintenance phase for Zubsolv treatment is unique for each person who is taking the drug.

What if I miss a dose?

If you miss a dose of Zubsolv, take it as soon as you remember. If it’s almost time for your next dose, just skip the missed dose. Take your next dose at the regular time. Do not take two doses to make up for the missed dose. This can increase your risk of serious side effects.

To help make sure that you don’t miss a dose, try setting a reminder in your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Possibly. Zubsolv is meant to be used as a long-term treatment. If you and your doctor determine that Zubsolv is helping you meet your treatment goals, you’ll likely take it long term.

You may wonder how Zubsolv compares to other medications that are prescribed for similar uses. Here we look at how Zubsolv and Suboxone are alike and different.

About

Zubsolv and Suboxone both contain the same two active drugs: buprenorphine and naloxone. However, Zubsolv and Suboxone come as different forms.

Uses

Zubsolv and Suboxone are both approved by the Food and Drug Administration (FDA) to treat opioid dependence (now called opioid use disorder).

These drugs are both approved for use in combination with counseling and behavioral therapy.

Drug forms and administration

Zubsolv comes as a tablet that you place under your tongue (a sublingual tablet). It’s available in six strengths:

  • 0.7 mg of buprenorphine and 0.18 mg of naloxone
  • 1.4 mg of buprenorphine and 0.36 mg of naloxone
  • 2.9 mg of buprenorphine and 0.71 mg of naloxone
  • 5.7 mg of buprenorphine and 1.4 mg of naloxone
  • 8.6 mg of buprenorphine and 2.1 mg of naloxone
  • 11.4 mg of buprenorphine and 2.9 mg of naloxone

Suboxone comes as a film that you place either on the inside of your cheek (called buccal administration) or under your tongue (called sublingual administration). Suboxone is available in four strengths:

  • 2 mg of buprenorphine and 0.5 mg of naloxone
  • 4 mg of buprenorphine and 1 mg of naloxone
  • 8 mg of buprenorphine and 2 mg of naloxone
  • 12 mg of buprenorphine and 3 mg of naloxone

Zubsolv and Suboxone are both given in these two phases:

  • induction (beginning) phase:
    • days 1 and 2 of treatment are called the induction phase
    • on day 1, either Zubsolv or Suboxone is taken up to several times, depending on the dosage your doctor prescribes for you
    • on day 2, either Zubsolv or Suboxone is taken once a day
  • maintenance (ongoing) phase:
    • day 3 of treatment is the start of the maintenance phase
    • either Zubsolv or Suboxone is taken once a day
    • the length of treatment with either drug will be unique to each person

Side effects and risks

Zubsolv and Suboxone both contain buprenorphine and naloxone. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

Common side effects can occur with both Zubsolv and Suboxone (when they’re taken individually). Examples of these side effects include:

  • headache
  • nausea
  • vomiting
  • constipation
  • sweating
  • insomnia (trouble sleeping)
  • peripheral edema (swelling in your lower legs and hands)
  • belly pain
  • opioid withdrawal symptoms (such as body aches, belly cramps, and fast heart rate)
  • a numb feeling inside your mouth
  • pain in your mouth or throat, or on your tongue
  • redness inside your mouth

Serious side effects

Serious side effects can occur with both Zubsolv and Suboxone (when they’re taken individually). Examples of these side effects include:

  • central nervous system depression (slowed brain function), including respiratory depression (very slow breathing)
  • adrenal gland problems
  • liver damage, including hepatitis
  • severe opioid withdrawal symptoms
  • orthostatic hypotension (low blood pressure when you stand up quickly)
  • increased blood pressure in your brain
  • increased blood pressure in your biliary tract (area of your body that includes your liver and gallbladder)
  • severe allergic reaction
  • trouble driving or using heavy machinery

Effectiveness

Zubsolv and Suboxone are both used to treat opioid use disorder. They’re used in combination with counseling and behavioral therapy.

In a clinical study, Zubsolv was compared to Suboxone in people with opioid dependence. Both drugs were found effective for 15 days of treatment. By day 15 of treatment, 75% of people taking Zubsolv were still in treatment. Of people taking Suboxone, 74% were still in treatment. Researchers concluded that Zubsolv and Suboxone had similar effectiveness overall.

According to the American Society of Addiction Medicine (ASAM), the combination of buprenorphine and naloxone is effective in treating opioid use disorder. ASAM doesn’t recommend one medication (either Zubsolv or Suboxone) over the other. Instead, they recommend that you discuss the pros and cons of each drug with your doctor and choose the one that’s best for you.

Costs

Zubsolv and Suboxone are both brand-name drugs. There are currently no generic forms of Zubsolv, but there are generic forms of Suboxone. Brand-name medications usually cost more than generics.

Zubsolv and Suboxone generally cost about the same. The generic forms of Suboxone may cost less than either brand-name drug. The actual price you’ll pay for either drug depends on your dose, your insurance plan, your location, and the pharmacy you use.

You may wonder how Zubsolv compares with other medications that are prescribed for similar uses. Here we look at how Zubsolv and Subutex are alike and different.

Suboxone contains two active drugs: buprenorphine and naloxone. Subutex was a brand-name drug that contained buprenorphine, one of Suboxone’s active drugs. Subutex is no longer available as a brand-name drug, but buprenorphine is available as a generic medication.

Buprenorphine and Zubsolv are both FDA-approved for treating opioid dependence (now called opioid use disorder). They’re both approved for use in combination with counseling and behavioral therapy.

Zubsolv comes as a tablet that you place under your tongue (a sublingual tablet). When used for opioid use disorder, buprenorphine is available as an oral film, a sublingual tablet, and an implant for under your skin.

Zubsolv and buprenorphine are both considered to be effective for treating opioid use disorder. Your doctor or pharmacist can provide more information about how these two drugs compare.

Zubsolv can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Zubsolv. These lists do not include all possible side effects. For more information, you can refer to Zubsolv’s prescribing information.

For more information on the possible side effects of Zubsolv, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be bothersome.

More common side effects

The more common side effects of Zubsolv can include:

  • headache
  • nausea
  • vomiting
  • constipation
  • sweating
  • insomnia (trouble sleeping)
  • peripheral edema (swelling in your lower legs and hands)
  • pain, such as pain in your belly
  • opioid withdrawal symptoms, such as body aches, belly cramps, and fast heart rate (see the “Side effect details” section below for more information)

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Zubsolv and want to tell the FDA about it, visit MedWatch.

Serious side effects

Serious side effects from Zubsolv aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include the following:

  • Respiratory depression (very slow breathing). Symptoms can include:
    • sleepiness
    • shortness of breath
    • slow and shallow breathing
    • bluish-colored lips, toes, and fingers
    • confusion
    • seizures
    • coma
    • death
  • Central nervous system depression (slowed brain function). Symptoms can include:
    • respiratory depression
    • slow or slurred speech
    • blurred vision
    • slow reflexes
    • excessive sleepiness
    • slowed heart rate
    • confusion
    • lack of energy
    • coma
  • Adrenal gland problems. Symptoms can include:
    • nausea
    • vomiting
    • weakness
    • fatigue (lack of energy)
    • dizziness
    • low blood pressure
  • Liver damage, including hepatitis. Symptoms can include:
    • loss of appetite
    • weight loss
    • belly pain
    • dark-colored urine
    • yellowing of your skin or the whites of your eyes
    • itchy skin
    • nausea
  • Severe opioid withdrawal symptoms. These can include:
    • sweating
    • shakiness
    • goose bumps
    • diarrhea
    • vomiting
    • runny nose
    • watery eyes
    • muscle aches
  • Orthostatic hypotension (low blood pressure when you stand up quickly). Symptoms can include:
    • feeling dizzy when you stand up or sit up too fast
  • Increased blood pressure in your brain. Symptoms can include:
    • pinpoint pupils (pupils, the part of your eye that lets light inside, that are abnormally small)
    • headache
    • confusion
  • Increased blood pressure in your biliary tract (an area of your body that includes your liver and gallbladder). Symptoms can include:
    • belly pain
    • itchy skin
    • dark-colored urine
    • loss of appetite
    • nausea
  • Dental problems, which can include:
    • tooth decay
    • infection
    • tooth loss, in severe cases
  • Severe allergic reaction. (See the “Side effect details” section below.)

Many of the common and serious side effects of Zubsolv can make driving unsafe. Don’t drive or operate heavy machinery until you know how Zubsolv will affect your body.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Zubsolv. It’s not known for sure how often people taking Zubsolv have an allergic reaction. Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Zubsolv. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Constipation

You may have constipation while you’re using Zubsolv.

It’s not known for sure how often people taking Zubsolv have constipation. But constipation is an expected side effect from opioids (such as buprenorphine, which is an active drug in Zubsolv).

The American Gastroenterological Association recommends using laxatives to relieve constipation caused by opioids. Examples of laxatives that may be used to treat constipation include:

  • bisacodyl (Dulcolax)
  • senna (Senokot, Ex-Lax)
  • polyethylene glycol (MiraLAX)
  • magnesium citrate
  • magnesium hydroxide (Phillips’ Milk of Magnesia)

Prescription medications are also available to treat constipation caused by opioids. Examples of these drugs include:

  • naloxegol (Movantik)
  • lubiprostone (Amitiza)
  • methylnaltrexone (Relistor)

If you’re having constipation while taking Zubsolv, talk with your doctor. They can recommend safe and effective ways to help you maintain healthy bowel movements.

Headaches

You may have headaches while you’re using Zubsolv. These are one of the most common side effects of the drug. In a clinical study, 7% of people who took Zubsolv for two days had headaches. Of those taking only buprenorphine (one of the active drugs in Zubsolv), 7% of people had headaches.

If you have headaches while taking Zubsolv, talk with your doctor. They can recommend safe and effective ways to prevent and treat headaches.

Withdrawal symptoms

You may have opioid withdrawal symptoms while you’re using Zubsolv. It’s not known for sure how many people taking Zubsolv have withdrawal symptoms. But this is a common side effect of treatment with buprenorphine (one of the active drugs in Zubsolv).

Symptoms of opioid withdrawal may feel similar to symptoms of a severe influenza infection. Symptoms of withdrawal can include:

  • fast heart rate
  • feeling irritable or anxious
  • sweating
  • runny nose
  • pain in your joints
  • tremor (shakiness)
  • stomach cramps
  • nausea
  • vomiting
  • diarrhea

Withdrawal symptoms can occur when you first start taking Zubsolv. This is because naloxone, one of the drugs in Zubsolv, can block the effects of the opioid in your body. This can put your body into withdrawal right away.

Your risk of having severe withdrawal symptoms when you start taking Zubsolv can be lowered. To do this, your doctor will have you wait at least six hours between your last opioid dose and your first Zubsolv dose. Letting this time pass will allow the opioids to be cleared from your body as much as possible.

Risk of addiction and misuse

There is a risk of drug addiction and misuse (also called abuse) while you’re using Zubsolv. This is because one of the drugs contained in Zubsolv, called buprenorphine, is an opioid (strong pain reliever).

All opioids have the potential to be misused. Misuse is when someone takes a drug at doses higher than what their doctor prescribes or takes the drug more often than their doctor prescribes. Misusing buprenorphine increases your risk of serious side effects, overdose, and even death.

Buprenorphine can also cause physical dependence. With physical dependence on a drug, your body needs to have the drug in order to feel normal. If you stop taking the drug without slowly weaning off of it, you can have withdrawal symptoms. You may have some opioid withdrawal symptoms when you stop taking Zubsolv. However, the symptoms caused by stopping Zubsolv are typically less severe than symptoms caused by stopping other opioid drugs.

Because Zubsolv contains an opioid, some people may try to get the medication even when it’s not prescribed for them. You should take Zubsolv only if your doctor prescribes it for you. You shouldn’t share this drug with anyone else. Doing so is against the law.

Talk with your doctor if you have any concerns about how to safely use Zubsolv. They will work with you to lower your risk of addiction, abuse, misuse, and dependence.

Zubsolv is available as a brand-name medication. There is currently no generic form available.

Zubsolv contains two active drug ingredients: buprenorphine and naloxone.

The Food and Drug Administration (FDA) approves prescription drugs such as Zubsolv to treat certain conditions. Zubsolv may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

Zubsolv for opioid dependence

Zubsolv is FDA-approved to treat opioid dependence. This condition is now called opioid use disorder by healthcare professionals. Zubsolv is approved for use in combination with counseling and other forms of support, such as behavioral therapy.

Opioid use disorder is a chronic (ongoing) disorder. It can be caused by using opioids on a regular basis.

When someone is physically dependent on opioids, their body needs to have opioids in order to feel normal. When someone who is dependent on opioids stops taking them, they will have withdrawal symptoms, such as anxiety, sweating, and diarrhea.

During studies, Zubsolv had similar effects in people with opioid use disorder as did buprenorphine (one of the active drugs in Zubsolv). Based on the results of two clinical studies, the FDA determined that Zubsolv was effective at treating opioid use disorder.

The American Society of Addiction Medicine (ASAM) recommends the combination of buprenorphine and naloxone as an effective option to treat opioid use disorder. This combination of drugs comes in different forms and brands. ASAM doesn’t recommend any particular form of these drugs over the other. You and your doctor should discuss the pros and cons of each form and choose the option that’s best for you.

Zubsolv for other conditions

In addition to the use listed above, Zubsolv may be used off-label. Off-label drug use is when a drug that’s approved for a specific purpose is prescribed for a different one that’s not approved.

Zubsolv for pain (may be an off-label use)

Zubsolv is not approved to treat pain, but it may be prescribed off-label for this purpose.

Both ASAM and the American Pain Society recommend using buprenorphine (one of the active drugs in Zubsolv) in people with opioid use disorder and pain. However, ASAM states that buprenorphine may not provide enough pain relief for people with severe pain.

Zubsolv is approved by the Food and Drug Administration (FDA) to treat opioid dependence (opioid use disorder). It’s approved for use in combination with counseling and behavioral therapy.

Several types of support are available that can be used to help treat opioid use disorder. These include:

  • individual therapy
  • group therapy
  • family therapy
  • group homes
  • inpatient hospital treatment programs

Talk with your doctor about which types of counseling and behavioral therapies will help you meet your treatment goals.

You should not drink alcohol while you’re taking Zubsolv. Drinking alcohol while taking Zubsolv increases your risk of serious, life-threatening side effects. These side effects include central nervous system depression (slowed brain function), which can cause:

  • respiratory depression (very slow breathing)
  • sedation (sleepiness, loss of coordination, and trouble thinking clearly)
  • coma
  • death

If you are considering using Zubsolv and you have trouble avoiding alcohol, talk with your doctor about whether Zubsolv treatment is safe for you.

Zubsolv can interact with several other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Zubsolv and other medications

Below are lists of medications that can interact with Zubsolv. These lists do not contain all the drugs that may interact with Zubsolv.

Before taking Zubsolv, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Zubsolv and other opioids

Taking Zubsolv with other opioids (strong pain relievers) can increase your risk of serious side effects, such as slowed breathing, trouble staying awake, coma, and even death.

You shouldn’t take other opioids with Zubsolv. Examples of other opioids include:

  • hydrocodone (Zohydro ER)
  • oxycodone (Roxicodone, Xtampza ER)
  • hydromorphone (Dilaudid)
  • fentanyl (Abstral, Actiq, Duragesic, Subsys)
  • methadone (Dolophine, Methadose)
  • morphine (Kadian, MS Contin)
  • tramadol (ConZip, Ultram)

Many combination medications (medications made from more than one drug) also contain opioids. Be sure to tell your doctor about all pain medications that you’re taking.

Zubsolv and certain anxiety medications

Taking Zubsolv with certain anxiety medications can increase your risk for serious side effects, including slowed breathing, trouble staying awake, coma, and even death.

To avoid these serious side effects, you shouldn’t take Zubsolv with certain anxiety medications unless you don’t have any other treatment option for your anxiety. If you need to take an anxiety medication with Zubsolv, your doctor will likely prescribe the lowest dosage of each drug that’s effective for you. Your doctor will also monitor you more closely for side effects while you’re taking the drugs together.

Examples of anxiety medications that can cause serious side effects if taken with Zubsolv include:

Zubsolv and certain insomnia medications

Taking Zubsolv with certain medications used to treat insomnia (trouble sleeping) can increase your risk for slowed breathing, trouble staying awake, coma, and even death.

You shouldn’t take Zubsolv with insomnia medications unless there aren’t any other treatment options for your insomnia. If you need to take medication for insomnia while you’re using Zubsolv, your doctor will likely prescribe the lowest dosage of each drug that’s effective for you. Your doctor will also monitor you more closely for serious side effects while you’re taking the drugs together.

Examples of insomnia medications that can cause serious side effects if taken with Zubsolv include:

  • zolpidem (Ambien and Ambien CR, Edluar, Zolpimist)
  • eszopiclone (Lunesta)
  • ramelteon (Rozerem)
  • zaleplon (Sonata)
  • trazodone

Zubsolv and certain muscle relaxants

Taking certain muscle relaxants with Zubsolv can increase your risk for serious side effects. These side effects include slowed breathing, trouble staying awake, coma, and even death.

You shouldn’t take certain muscle relaxants with Zubsolv unless there aren’t any other treatment options for your muscle condition. If you need to take a muscle relaxant with Zubsolv, your doctor will likely prescribe the lowest dosage of each drug that’s effective for you. Your doctor will also monitor you more closely for serious side effects while you’re taking the drugs together.

Examples of muscle relaxants that can increase your risk for serious side effects if taken with Zubsolv include:

  • carisoprodol (Soma)
  • cyclobenzaprine (Amrix)
  • metaxalone (Skelaxin)
  • methocarbamol (Robaxin)
  • tizanidine (Zanaflex)

Zubsolv and certain antibiotics and antifungals

Taking Zubsolv with certain antibiotics and antifungals can increase the levels of buprenorphine (one of the drugs in Zubsolv) in your body. This happens because certain antibiotics and antifungals prevent your body from breaking down the drugs contained in Zubsolv.

This interaction can lead to high levels of buprenorphine in your body, which increases your risk for serious side effects. Serious side effects that can occur include slowed breathing, trouble staying awake, coma, and even death.

If you need to take certain antibiotics or antifungals while you’re taking Zubsolv, your doctor will likely decrease your Zubsolv dosage until you’ve finished taking the other medication. This will help prevent serious side effects from occurring.

Examples of certain antibiotics that can increase your risk for serious side effects if taken with Zubsolv include:

  • erythromycin (Ery-Tab, Eryped, many others)
  • clarithromycin (Biaxin XL)

Examples of certain antifungals that can increase your risk for serious side effects if taken with Zubsolv include:

  • fluconazole (Diflucan)
  • itraconazole (Omnel, Sporanox, Tolsura)
  • ketoconazole (Extina, Xolegel)
  • voriconazole (Vfend)

Zubsolv and certain seizure medications

Taking Zubsolv with certain seizure medications can decrease Zubsolv levels in your body. This can make Zubsolv less effective for you. It can also cause your body to have opioid withdrawal symptoms.

If you need to take Zubsolv while you’re using a seizure medication, your doctor may increase your dose of Zubsolv for a while. They will also monitor you more closely for signs of opioid withdrawal.

Examples of seizure medications that can make Zubsolv less effective include:

  • carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
  • phenytoin (Dilantin, Phenytek)

Zubsolv and certain antidepressants

Taking Zubsolv with certain antidepressants can increase your risk of a serious condition called serotonin syndrome. With this syndrome, high levels of serotonin build up inside your body. This can cause severe effects, including anxiety, tremors, diarrhea, fast heartbeat, fever, and seizures.

If you need to take certain antidepressants with Zubsolv, your doctor will monitor you more closely for signs of serotonin syndrome. If you develop serotonin syndrome, your doctor will stop your Zubsolv treatment until your symptoms are treated. Your doctor may also recommend a different type of treatment for you.

There are many antidepressants that can cause serotonin syndrome if taken with Zubsolv. Some examples of these medications include:

Zubsolv and certain diuretics

Taking certain diuretics (also called water pills) with Zubsolv can decrease the effectiveness of the diuretics. This can increase your blood pressure or lead to swelling.

If you need to take a diuretic with Zubsolv, your doctor may increase the dosage of the diuretic.

Examples of diuretics that can be less effective if taken with Zubsolv include:

  • hydrochlorothiazide
  • furosemide (Lasix)
  • torsemide (Demadex)
  • bumetanide (Bumex)
  • triamterene (Dyrenium)
  • spironolactone (Aldactone, CaroSpir)

Not much is known about the safety of Zubsolv use during pregnancy. In animal studies, buprenorphine (one of the drugs in Zubsolv) given to pregnant animals caused fetal harm. However, animal studies don’t always predict what will happen in humans.

Treatment guidelines for opioid dependency during pregnancy

The American College of Obstetricians and Gynecologists (ACOG) provides treatment recommendations for opioid dependency (opioid use disorder) during pregnancy. ACOG states that all pregnant people with opioid use disorder should be treated with medication for the condition.

ACOG adds that taking medications like Zubsolv to treat opioid use disorder is safer than using illegal or prescription opioids without your doctor’s supervision.

Treating opioid use disorder during pregnancy can be beneficial in many ways, including:

  • preventing opioid withdrawal symptoms that could harm the fetus
  • reducing your risk of relapse (return to using drugs after attempting to stop using them)
  • helping you keep regular appointments with your doctor for prenatal care and medical advice
  • reducing the risk of certain problems in your pregnancy

According to ACOG, the combination of buprenorphine and naloxone (the active drugs in Zubsolv) is a safe treatment option for opioid use disorder during pregnancy.

Risks of Zubsolv treatment during pregnancy

One risk of using Zubsolv treatment during pregnancy is neonatal opioid withdrawal syndrome (NOWS). This is a serious, but expected, withdrawal syndrome that occurs in babies whose female* parent took opioids during pregnancy.

Symptoms of NOWS can include:

  • poor feeding
  • irritability
  • excessive crying
  • diarrhea

Babies born with NOWS are monitored and treated in the hospital for a while before they can safely go home. There is very little known about the long-term effects of NOWS on these babies.

The benefits of treating opioid use disorder in pregnancy with Zubsolv should be weighed against the risks of NOWS. The benefits should also be compared to the risks of not treating opioid use disorder.

If you have opioid use disorder, and you’re pregnant or considering becoming pregnant, talk with your doctor about treatment options. They can discuss the treatment options available. They‘ll also discuss the benefits and risks of treating this disorder during pregnancy.

If you’re already taking Zubsolv, and you have an unplanned pregnancy, don’t stop taking Zubsolv unless your doctor tells you to. Also, your dosage of Zubsolv may need to be changed during pregnancy. This is because your body clears the drug faster when you’re pregnant than it does when you’re not pregnant.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

Not much is known about how safe it is to use Zubsolv during pregnancy. If you or your sexual partner are able to become pregnant, talk with your doctor about your birth control needs while you’re using Zubsolv.

Zubsolv is probably safe to use as directed by your doctor while you’re breastfeeding.

The American College of Obstetricians and Gynecologists (ACOG) recommends that most females* who are on stable treatment for opioid use disorder with a medication like Zubsolv should breastfeed their children. Very small amounts of the drug will pass into your breast milk. If you breastfeed while you’re taking Zubsolv, watch your child closely for increased sleepiness or trouble breathing. If you notice these side effects in your child, call 911 right away.

However, it’s important that you have other options available to feed your child, such as formula milk or baby food. These can be used to feed your child in case you have a relapse (return to using or misusing a drug after you’ve attempted to stop using it). Feeding your child with these alternatives if you relapse will prevent your child from being exposed to drugs other than Zubsolv.

There are some exceptions to ACOG’s recommendation for breastfeeding. It’s important to talk with your doctor about whether it’s safe for you to breastfeed while you’re taking Zubsolv.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

As with all medications, the cost of Zubsolv can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance

If you need financial support to pay for Zubsolv, or if you need help understanding your insurance coverage, help is available.

Programs are available that may help lower the cost of Zubsolv, or even provide a certain number of tablets free of charge. For more information and to find out if you’re eligible for support, call 855-982-7658 or visit the program website.

Other drugs are available that can treat opioid dependence (opioid use disorder). Some may be better suited for you than others. If you’re interested in finding an alternative to Zubsolv, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of other drugs that can be used to treat opioid use disorder include:

You may wonder how Zubsolv compares with other medications that are prescribed for similar uses, such as Bunavail. Bunavail is no longer available as a brand-name drug. But a generic version of Bunavail is available, which is a buprenorphine/naloxone film. In this section, we discuss how these two drugs compare.

About

Buprenorphine and naloxone are the active drugs in Zubsolv. The generic buprenorphine/naloxone film discussed here comes in a different form and different strengths than Zubsolv. There’s not currently a generic version of Zubsolv available.

Uses

Zubsolv and buprenorphine/naloxone film are both approved by the Food and Drug Administration (FDA) to treat opioid dependence (now called opioid use disorder). Both drugs are approved for use in combination with counseling and behavioral therapy.

Drug forms and administration

Zubsolv comes as a tablet that you place under your tongue (a sublingual tablet). It’s available in six strengths:

  • 0.7 milligrams (mg) of buprenorphine and 0.18 mg of naloxone
  • 1.4 mg of buprenorphine and 0.36 mg of naloxone
  • 2.9 mg of buprenorphine and 0.71 mg of naloxone
  • 5.7 mg of buprenorphine and 1.4 mg of naloxone
  • 8.6 mg of buprenorphine and 2.1 mg of naloxone
  • 11.4 mg of buprenorphine and 2.9 mg of naloxone

Buprenorphine/naloxone comes as a sublingual film that can be placed under your tongue or on the inside of your cheek. The film dissolves in your mouth. This drug is available in three strengths:

  • 2 mg of buprenorphine and 0.5 mg of naloxone
  • 8 mg of buprenorphine and 2 mg of naloxone
  • 12 mg of buprenorphine and 3 mg of naloxone

Zubsolv and buprenorphine/naloxone film are each given in these two phases:

  • induction (beginning) phase:
    • days 1 and 2 of treatment are called the induction phase
    • on day 1, either Zubsolv or buprenorphine/naloxone film is taken up to several times, depending on the dosage your doctor prescribes for you
    • on day 2, either Zubsolv or buprenorphine/naloxone film is taken once a day
  • maintenance (ongoing) phase:
    • day 3 of treatment is the start of the maintenance phase
    • either Zubsolv or buprenorphine/naloxone film is each taken once a day
    • the length of treatment with either drug will be unique to each person

Side effects and risks

Zubsolv and buprenorphine/naloxone film (the generic form of the discontinued drug Bunavail) both contain buprenorphine and naloxone. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

Common side effects can occur with both Zubsolv and buprenorphine/naloxone film (when they’re taken individually). Examples of these side effects include:

  • headache
  • nausea
  • vomiting
  • constipation
  • sweating
  • insomnia (trouble sleeping)
  • peripheral edema (swelling in your lower legs and hands)
  • belly pain
  • opioid withdrawal symptoms, such as body aches, belly cramps, and fast heart rate

Serious side effects

Serious side effects can occur with both Zubsolv and buprenorphine/naloxone film (when they’re taken individually). Examples of these side effects include:

  • central nervous system depression (slowed brain function), including respiratory depression (very slow breathing)
  • adrenal gland problems
  • liver damage, including hepatitis
  • severe opioid withdrawal symptoms
  • orthostatic hypotension (low blood pressure when you stand up quickly)
  • increased blood pressure in your brain
  • increased blood pressure in your biliary tract (an area in your body which includes your liver and gallbladder)
  • severe allergic reaction
  • trouble driving or operating heavy machinery

Effectiveness

Zubsolv and buprenorphine/naloxone film are both FDA-approved to treat opioid use disorder. They’re both approved for use in combination with counseling and behavioral therapy.

These medications haven’t been directly compared in clinical studies. However, studies have found that both Zubsolv and buprenorphine/naloxone film provided amounts of buprenorphine that are similar to the amount provided by a drug called Suboxone.

The FDA approved Zubsolv and Bunavail based on clinical studies that showed that both drugs were highly similar to Suboxone. Suboxone has been found effective for treating opioid use disorder, as has generic buprenorphine/naloxone film.

In current treatment guidelines, the American Society of Addiction Medicine (ASAM) recommends the combination of buprenorphine and naloxone to treat opioid use disorder. This combination of drugs comes in different forms and brands. Your doctor will discuss the pros and cons of each drug with you.

Costs

Zubsolv is a brand-name drug, and buprenorphine/naloxone film is a generic drug. Brand-name medications usually cost more than generics. There are currently no generic forms of Zubsolv available.

The actual price you’ll pay for either drug depends on your dose, your insurance plan, your location, and the pharmacy you use.

You should take Zubsolv according to your doctor or healthcare professional’s instructions.

You’ll take Zubsolv by placing a tablet (called a sublingual tablet) under your tongue. Once there, the tablet will dissolve within a few minutes.

If you need to take more than one tablet for your dose, you should place the tablets in different areas under your tongue, all at the same time.

After you take each dose of Zubsolv, gently swish some water around in your mouth and swallow it. Be sure to swish around your teeth and gums. And avoid brushing your teeth for at least 1 hour after taking Zubsolv. Doing these things helps ensure that you get your full dose.

You can see these step-by-step instructions for taking Zubsolv. Be sure to follow your doctor’s exact instructions.

When to take

Zubsolv should be taken once a day during the maintenance phase of treatment. It can be taken at any time of the day.

To help make sure that you don’t miss a dose, try setting a reminder in your phone. A medication timer may be useful, too.

Taking Zubsolv with food

You shouldn’t eat food or drink anything while you’re taking your dose of Zubsolv. Wait until the tablet has completely dissolved in your mouth before you have anything to eat or drink. This will help make sure that you get your full dose of Zubsolv.

If your mouth is dry before you take your Zubsolv tablet, drink a sip of water first to moisten your mouth. But make sure your hands aren’t wet when you touch your Zubsolv tablet. This could make the tablet start to dissolve before you place it under your tongue.

Can Zubsolv be crushed, split, or chewed?

Zubsolv should be taken whole. Do not crush, split, or chew Zubsolv tablets. Doing so could make Zubsolv less effective and raise your risk of serious side effects.

Zubsolv is approved to treat opioid dependence (now called opioid use disorder).

What is opioid use disorder?

Opioid use disorder is a chronic (long-term) condition that can cause you to be physically dependent on opioids. When someone is physically dependent on opioids, their body needs to have opioids in order to feel normal. If the person stops taking opioids, they will have withdrawal symptoms such as anxiety, sweating, diarrhea, and others.

Dependence on opioids can be caused by using opioids on a regular basis. Dependence can also be caused by misusing opioids. Misusing opioids means that you’re taking them at a higher dose or using them more often than prescribed by your doctor.

What does Zubsolv do?

Zubsolv contains two active drugs: buprenorphine and naloxone. Here we review how these drugs work together to treat opioid use disorder.

Buprenorphine

Buprenorphine is a weak opioid drug. It’s considered an opioid partial agonist-antagonist.

It’s considered a partial agonist because it activates (turns on) the same nerve pathways in your brain as other opioids do. However, buprenorphine has a “ceiling effect.” This means that its effects don’t keep increasing after you’ve had a certain dose of the drug.

Buprenorphine is called an antagonist because it also blocks certain effects of opioids.

Buprenorphine provides some of the effects of opioids that a person’s body was dependent on. By doing this, the drug helps reduce withdrawal symptoms and opioid cravings. However, it’s unlikely that taking buprenorphine will make you feel “high” or lead to misusing the drug.

Naloxone

Naloxone is considered an opioid antagonist. This is because it blocks the effects of opioids in your body. It’s added to Zubsolv to prevent misuse of Zubsolv.

If you were to misuse Zubsolv (including taking it a different way than how your doctor prescribes it), the naloxone may replace any opioids that may be active in your body. This can cause immediate opioid withdrawal symptoms, such as anxiety, sweating, diarrhea, vomiting, and others. However, if you take Zubsolv tablets under your tongue as directed, you’re less likely to have opioid withdrawal symptoms.

How long does it take to work?

Zubsolv starts working to reduce opioid withdrawal and opioid cravings on your first day of treatment.

Here are answers to some frequently asked questions about Zubsolv.

What do Zubsolv tablets taste like?

Zubsolv tablets have a menthol (minty) taste.

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.

Will I have withdrawal symptoms if I stop using Zubsolv?

You may have withdrawal symptoms if you stop taking Zubsolv. This is more likely to happen if you stop taking it abruptly, rather than slowly weaning off of the drug. However, the withdrawal symptoms that can occur after abruptly stopping Zubsolv tend to be less severe than those that occur after stopping other opioids (strong pain relievers).

In order to decrease your risk of withdrawal symptoms, your doctor will prescribe lower dosages of Zubsolv over time. This is called a drug taper (slow weaning off of the drug). By taking lower dosages every few days, weeks, or months, your body has time to adjust to the lower drug levels. Eventually, you may be able to stop taking Zubsolv completely.

Don’t stop taking Zubsolv or lowering your dosages of Zubsolv unless your doctor tells you to do so. Trying to taper off of Zubsolv on your own may be less effective than if you taper off with your doctor’s help.

Will I gain weight while I’m using Zubsolv?

You might gain weight while you’re using Zubsolv.

Weight gain may happen for some people taking Zubsolv, but it’s not clear if this is caused by the medication itself. Instead, it might result from diet and lifestyle improvements these people may have experienced after they started treatment for opioid dependence.

One small study found that people who took a combination of buprenorphine and naloxone (the active drugs in Zubsolv) gained about 10 pounds after four months of treatment.

It’s also possible that for some people, weight gain is related to peripheral edema (swelling in your lower legs and hands). This type of swelling causes your body to hold more fluid than usual. This fluid can increase your body weight for a short time.

If you’re concerned about maintaining a weight that is healthy for you during Zubsolv treatment, talk with your doctor.

Can I switch from methadone to Zubsolv?

You possibly could, but that depends on your doctor’s recommendation. Switching from methadone to Zubsolv is an option for some people.

Both Zubsolv and methadone are used to treat opioid dependence, when they’re used in combination with counseling and behavioral therapy. However, there are important differences with how your body processes these two drugs. Switching from one drug to the other requires your doctor’s supervision. Having medical supervision will help you avoid serious side effects and opioid withdrawal symptoms.

Talk with your doctor about whether switching from methadone to Zubsolv is right for you. Don’t change your current treatment unless your doctor tells you to do so.

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 can increase the 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 with your doctor about whether Zubsolv is safe for you.
  • Bile duct damage or bile duct disease. Buprenorphine can increase the 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 with your doctor about whether Zubsolv is safe for you.
  • Intestinal damage or intestinal disease. Buprenorphine can have intestinal side effects, especially constipation. These side effects in your intestines can make it harder for your doctor to treat intestinal damage or intestinal disease. If you have intestinal conditions, talk with your doctor about whether Zubsolv is safe for you.
  • Heart problems or risk factors for heart problems. If you have heart problems or an increased risk of heart problems, buprenorphine may increase your risk of long QT syndrome. Long QT syndrome, also called QT prolongation, refers to abnormal electrical activity in your heart. Examples of heart problems and other conditions that increase your risk of long QT syndrome include hypokalemia, bradycardia, atrial fibrillation, and heart failure. If your doctor prescribes Zubsolv, they may monitor you more closely than usual during treatment. Be sure to talk with your doctor about your health history before starting Zubsolv treatment.
  • 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.

Note: For more information about the potential negative effects of Zubsolv, see the “Zubsolv side effects” section above.

Using more than the recommended dosage of Zubsolv can lead to serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

  • sedation (sleepiness, loss of coordination, and trouble thinking clearly)
  • low blood pressure
  • pinpoint pupils (pupils, the part of your eye that lets light inside, that are abnormally small)
  • respiratory depression (very slow breathing)
  • death

There is a serious risk of overdose in people who are opioid-naïve (people who’ve never taken opioids before). An overdose can happen in opioid-naïve people even if they take a low dose of Zubsolv.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Naloxone: A lifesaver

Naloxone (Narcan, Evzio) is a drug that can be injected to quickly reverse overdoses from opioids, including heroin. An opioid overdose can make it hard to breathe. This can be fatal if not treated in time.

If you or someone you love is at risk for an opioid overdose, talk with your doctor or pharmacist about naloxone. Ask them to explain the signs of an overdose and show you and your loved ones how to use naloxone.

In most states, you can get naloxone at a pharmacy without a prescription. Keep the drug on hand so you can easily access it in case of an overdose.

When you get Zubsolv from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Zubsolv tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C) in a tightly sealed container. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.

Keep Zubsolv tablets stored out of sight and out of reach of children and pets.

Disposal

If you no longer need to take Zubsolv and have leftover medication, it’s important to dispose of it safely.

You can search for an authorized location where you can dispose of drugs like Zubsolv on this website. If you’re unable to go to an authorized take-back location, Zubsolv tablets can be flushed down the toilet.

Disposing of Zubsolv safely helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Zubsolv (buprenorphine and naloxone) is approved by the Food and Drug Administration to treat opioid dependence.

It’s approved for use as part of a treatment plan that includes psychosocial support and counseling.

Mechanism of action

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 a misuse deterrent.

Pharmacokinetics and metabolism

Absorption following sublingual administration of buprenorphine and naloxone varies widely among those taking the drug. Buprenorphine is approximately 96% protein-bound, while naloxone is approximately 45% protein-bound.

Buprenorphine is metabolized primarily by CYP3A4. Naloxone is metabolized by glucuronidation, N-dealkylation, and reduction.

Mean elimination half-life ranges from 24 hours to 42 hours for buprenorphine, and 2 hours to 12 hours for naloxone.

Contraindications

Zubsolv is contraindicated in patients with a history of serious hypersensitivity to either buprenorphine or naloxone.

Misuse and dependence

Zubsolv is a Schedule III medication that can be misused, similar to other opioid drugs. The use of Zubsolv over time can lead to physical and psychological dependence. Misuse of Zubsolv can lead to overdose and death, particularly if used in combination with other central nervous system depressants (such as alcohol or benzodiazepines).

Risk of criminal diversion of Zubsolv tablets may be minimized by requiring frequent office visits in order for patients to obtain prescriptions, particularly in the beginning. Zubsolv treatment should be undertaken in combination with counseling and behavioral therapy.

Physical and psychological dependence upon Zubsolv can occur following long-term use of the drug. Abrupt discontinuation of Zubsolv is likely to cause withdrawal symptoms. Appropriate tapering is recommended.

Storage

Zubsolv tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C). It should be stored out of sight and reach of children and pets. Any unused Zubsolv tablets or Zubsolv tablets that are no longer needed should be flushed down the toilet.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.