Opioid Dependence

What is opioid dependence?

Opioid dependence is a chronic relapsing disorder—similar to diabetes or high blood pressure. Both legitimate use and misuse of opioids can lead to dependence. Opioids can physically change the brain. After a while, the brain starts to think that it needs opioids to function normally. This causes the cravings and symptoms of withdrawal that someone with opioid dependence often experiences when the effects of opioids begin to wear off.1

Like other chronic disorders2:

  • There is no known cure for opioid dependence
  • Some people are more likely to develop opioid dependence than others
  • Relapse is common and may be successfully addressed with the right treatment plan, which may include a combination of support and/or counseling and medication
  • You can still live a healthy, productive life with the right treatment plan

People who take opioids recreationally without a valid prescription may get or take opioids from a friend or family member. Others may buy them on the street or from a mail-order company. Dependence can make people do things they wouldn’t ordinarily do to acquire opioids.2

How do I know if I am opioid dependent?

If you are a frequent user of opioids, you should speak to a doctor for an evaluation. He or she will determine whether you have opioid dependence and the best course of treatment for you.

Is there a cure for opioid dependence?

There is no known cure for opioid dependence. However, studies have shown that it can be managed successfully over the long term with an appropriate treatment plan that includes medication, support, and counseling/ behavioral therapy.1

Why do people become dependent on opioids?

The frequent and long-term use of opioids changes nerve cells in the brain such that normal brain function begins to require the presence of opioids. That is why people with opioid dependence develop cravings for opioids. Additionally, the parts of the brain that process learning, memory, and emotions are affected, thereby influencing an individual’s experience of the world around him or her.1

What is a relapse?

Relapse is a part of this chronic disorder of opioid dependence, just like symptom breakthrough is with other chronic conditions. Relapse happens when someone with opioid dependence who had stopped taking opioids begins taking opioids again.1

Long-term use of opioids causes physical changes in the brain that make people with opioid dependence feel like they need opioids in order to function properly. Because of this, people are at risk of having cravings or encountering triggers that can lead to relapse even if it’s been a long time since they stopped taking opioids.1

When people relapse, they sometimes feel like they have failed. But that isn’t always the case. Everyone has different needs, and a relapse can simply mean that a person isn’t getting the support and/or counseling he or she needs or that they may need to try a different medication. A comprehensive treatment plan can help people achieve their treatment goals.1

What can I do to help avoid a relapse?

To help avoid a relapse, it is important that you continue the treatment plan that your doctor prescribed for you. In addition, you should also avoid triggers that can lead to relapse, including1:

  • Stress at work or home
  • Relationship problems
  • Emotional pain or difficult situations
  • Pain from an injury or medical procedure
  • Certain people from your past
What if I have a relapse?

If you have a relapse, first understand that it is common and is nothing to be ashamed about. It’s important to call someone like a doctor, counselor, friend, or a loved one right away.


About RISE™

What is RISE?

RISE is an online support program for opioid dependence. Developed with the help of people with opioid dependence, RISE was designed to meet the needs of you and your support network. Choose from a selection of online tools and resources and build the plan you feel is most helpful to your recovery. Learn more.

Are there other kinds of support available to me?

An active support network and counseling are a key part of an effective treatment plan. There are a number of different kinds of counseling available for treating opioid dependence. Visit RISE or check our Helpful Links page to find additional support available to you.


About ZUBSOLV®

What is ZUBSOLV?

ZUBSOLV 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.

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.

What is different about ZUBSOLV?

ZUBSOLV has an advanced formulation and dissolves sublingually, or under the tongue. Because more of the medication in the tablet gets into the bloodstream, a lower dose of ZUBSOLV is equivalent to a higher dose of other buprenorphine/naloxone tablets, in which less medication from the tablet gets into the bloodstream. This means that ZUBSOLV delivers the same amount of active drug as compared to Suboxone tablets but with a lower starting dose.

ZUBSOLV has the same active ingredients as the previously approved buprenorphine/naloxone sublingual formulations. Naloxone blocks the “high” effect if the medication is injected. This helps to discourage intravenous misuse.4

How should ZUBSOLV be taken?

ZUBSOLV is a small sublingual tablet—meaning that it dissolves under the tongue. Because of its advanced formulation, ZUBSOLV dissolves within minutes. Chewing or swallowing the tablet or talking while the tablet is dissolving will prevent the medication from working as it should. Dosage & Administration

For more important information about how to take ZUBSOLV sublingual tablets, please see the Medication Guide.1

Do not stop taking ZUBSOLV suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using ZUBSOLV the right way.

What happens if I forget to take ZUBSOLV?

If you miss a dose of ZUBSOLV, take your medicine when you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regular time. Do not take 2 doses at the same time unless your doctor tells you to. If you are not sure about your dosing, call your doctor.

For more information on the safe use of ZUBSOLV, please see the Medication Guide.1

What are the side effects of taking ZUBSOLV?
  • ZUBSOLV can cause serious and life-threatening breathing problems. Call your doctor right away or get emergency help if:
  • You feel faint, dizzy, or confused
  • Your breathing gets much slower than is normal for you

These can be signs of an overdose or other serious problems.

An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using ZUBSOLV. Ask your doctor what you should do if you are taking one of these.

How long will I have to take ZUBSOLV?

How long you stay on treatment is an individual decision that can only be made with the guidance of your doctor and/or counselor or other support services.

Because opioid dependence is a chronic disorder, it is never really cured. Maintenance medications, like ZUBSOLV, allow you to manage your opioid dependence over the long term so that you can ultimately regain control of your life.1

  • ZUBSOLV contains an opioid that can cause physical dependence.
  • Do not stop taking ZUBSOLV without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.
  • Physical dependence is not the same as drug addiction.
  • ZUBSOLV is not for occasional or “as needed” use.
What happens if I stop taking ZUBSOLV?

Do not stop taking ZUBSOLV suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. To have fewer withdrawal symptoms, ask your doctor how to stop using ZUBSOLV the right way.

If you take too much ZUBSOLV go to the nearest hospital emergency room right away.

For more information on the safe use of ZUBSOLV, please see the Medication Guide.

How may treatment that includes ZUBSOLV help me?

Maintenance medications like ZUBSOLV, along with counseling/behavioral therapy, can help reduce cravings without making the person feel “high.”  This helps give people a chance to change their habits and to stop taking opioids. Maintenance medication, in combination with support and/or counseling, is critical to preventing relapse.1

Where can I find a doctor that can prescribe ZUBSOLV?

Some medications for opioid dependence, such as ZUBSOLV, are controlled substances; therefore, doctors have to become eligible to prescribe them.

To find a doctor that treats opioid dependence in your area, use the doctor locator.

How do I transition from Suboxone® to ZUBSOLV?

Your doctor will prescribe the right approach for you to transition from Suboxone to ZUBSOLV, determining the correct dose of ZUBSOLV. Depending on where you are in treatment, your doctor may supervise your transition to ZUBSOLV.

Do not switch from ZUBSOLV to other medicines that contain buprenorphine without talking with your doctor. 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 doctor will prescribe a starting dose of buprenorphine that may be different than other buprenorphine containing medicines you may have been taking.

What is the difference between ZUBSOLV and buprenorphine?

ZUBSOLV is a combination medication that contains buprenorphine as well as naloxone. ZUBSOLV has an advanced formulation and needs less buprenorphine to achieve the same effects as other available formulations of buprenorphine/naloxone.3

Do not inject (“shoot-up”) ZUBSOLV. Injecting ZUBSOLV may cause life-threatening infections and other serious health problems.

What happens if I take a benzodiazepine while taking ZUBSOLV?

Tell your doctor about all the medications you take. ZUBSOLV should be prescribed with caution to patients taking benzodiazepines or other drugs that act on the central nervous system, regardless of whether these drugs are prescribed by a physician or are being abused/misused. It is extremely dangerous to self-administer non-prescribed benzodiazepines while taking ZUBSOLV. There have been reports regarding coma and death associated with the concomitant use of buprenorphine and benzodiazepines. It is extremely dangerous to self-administer non-prescribed benzodiazepines while taking ZUBSOLV sublingual.

An overdose, and even death, can happen if you take benzodiazepines, sedatives, tranquilizers, or alcohol while using ZUBSOLV. Ask your doctor what you should do if you are taking one of these.3

Am I just substituting “one drug for another” when I take ZUBSOLV?

No. Although buprenorphine and naloxone, the active ingredients in ZUBSOLV, are also opioids, they work differently from opioid pain medications. Most opioid pain medications work by attaching to receptors in the brain to produce the effects of pain relief as well as euphoria, or the feeling of being “high.” ZUBSOLV contains an opioid that can cause physical dependence.

How is ZUBSOLV different?

ZUBSOLV has the same active ingredients as other buprenorphine and naloxone-containing formulations; however, ZUBSOLV has an advanced formulation. Because most of the medication in ZUBSOLV tablets gets into the bloodstream, a lower dose of ZUBSOLV is similar to a higher dose of Suboxone. The advanced formulation of ZUBSOLV also offers several more advantages:4

  • Menthol flavor
  • Fast dissolve time
  • Small tablet size, lower dose

Medication Guide

References:

  1. National Institute on Drug Abuse. Principles of drug addiction treatment: a research-based guide, 3rd edition. NIH Publication No. 12-4180 http://www.drugabuse.gov/sites/default/files/podat_1.pdf. Accessed May 11, 2013.
  2. US Department of Health and Human Services. Medication-assisted treatment for opioid addiction facts for families and friends. 2009; HHS Publication No. (SMA) 09-4443.
  3. Full Prescribing Information
  4. 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.

Ask your doctor about ZUBSOLV!

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 doctor 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 doctor can tell you more about the difference between physical dependence and addiction. Do not stop taking ZUBSOLV without talking to your doctor. You could become sick with uncomfortable withdrawal signs and symptoms because your body has become used to this medicine.

  • Your doctor may monitor liver function before and during treatment with ZUBSOLV.

  • ZUBSOLV is not recommended for initiation of treatment in patients with moderate hepatic impairment due to the increased risk of precipitated withdrawal. However, ZUBSOLV may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

  • 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 doctor about any side effect that bothers you or that does not go away.

  • Opioid use may cause adrenal insufficiency, a potentially life-threatening condition. Seek immediate medical attention if you experience nausea, vomiting, anorexia, fatigue, weakness, dizziness, or low blood pressure as these are signs and symptoms that may be associated with adrenal insufficiency.

  • Do not switch from ZUBSOLV to other medicines that contain buprenorphine without talking with your doctor. 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 doctor 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 doctor 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 doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

  • Cases of serotonin syndrome, a rare but potentially life-threatening condition, have been reported when opioids are used along with serotonergic drugs (such as medications used to treat depression and migraines). Be sure to inform your doctor if you are taking or plan to take any serotonergic medications while taking ZUBSOLV.

  • Before taking ZUBSOLV, tell your doctor 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 doctor if you are pregnant or plan to become pregnant.

  • Before taking ZUBSOLV, tell your doctor if you are breastfeeding or plan to breastfeed. Nursing mothers: Caution should be exercised when buprenorphine-containing products are administered to a nursing woman. Talk to your doctor about the best way to feed your baby. If you take ZUBSOLV, monitor your baby for drowsiness and difficulty breathing.

  • Chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.

  • 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.

For more information about ZUBSOLV (buprenorphine and naloxone) Sublingual Tablet (CIII), please see the respective full Prescribing Information and Medication Guide.