Skip to Content

buprenorphine and naloxone (oral/sublingual)

Generic Name: buprenorphine and naloxone (oral/sublingual) (BUE pre NOR feen and nal OX one (OR al / sub LIN gwal))
Brand Name: Bunavail, Suboxone, Zubsolv

What is buprenorphine and naloxone?

Buprenorphine is an opioid medication, sometimes called a narcotic. Naloxone blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse.

Buprenorphine and naloxone is a combination medicine used to treat narcotic (opiate) addiction. Buprenorphine and naloxone is not for use as a pain medication.

Buprenorphine and naloxone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about buprenorphine and naloxone?

This medicine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Taking buprenorphine and naloxone during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

What should I discuss with my healthcare provider before taking buprenorphine and naloxone?

You should not use this medicine if you are allergic to buprenorphine or naloxone (Narcan).

Some medicines can interact with buprenorphine and naloxone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure this medicine is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • enlarged prostate, urination problems;

  • liver or kidney disease;

  • abnormal curvature of the spine that affects breathing;

  • problems with your gallbladder, adrenal gland, or thyroid;

  • a history of drug abuse, alcohol addiction, or mental illness;

  • a history of head injury, brain tumor, or seizures; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

It is not known whether this medicine will harm an unborn baby. If you use buprenorphine and naloxone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Buprenorphine and naloxone can pass into breast milk and may cause drowsiness or breathing problems in the nursing baby. Tell your doctor if you are breast-feeding.

How should I take buprenorphine and naloxone?

Follow all directions on your prescription label. This medicine can slow or stop your breathing. Never use buprenorphine and naloxone in larger amounts, or for longer than prescribed.

This medicine may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away buprenorphine and naloxone is against the law.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use dry hands when handling the tablet or film. Drink a glass of water to moisten your mouth. Place the sublingual tablet or sublingual film under the tongue and allow it to dissolve. Place the buccal film in your mouth against the inside of your cheek and allow it to dissolve. Do not chew or cut a tablet or film, and do not swallow it whole.

If you switch between medicines containing buprenorphine, you may not use the same dose for each one. Follow all directions carefully.

Do not stop using buprenorphine and naloxone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

You will need frequent blood tests to check your liver function.

Wear a medical alert tag or carry an ID card stating that you take this medicine. Any medical care provider who treats you should know that you are being treated for narcotic addiction. Make sure your family members know you are using this medicine in case they need to speak for you during an emergency.

Never crush or break a buprenorphine and naloxone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death.

Store at room temperature away from moisture and heat. Keep this medicine in the foil pouch until ready to use. Discard the empty pouch in a place children and pets cannot get to.

Keep track of the amount of medicine used from each new bottle. Buprenorphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep unused buprenorphine and naloxone that is no longer needed. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused medicine down the toilet.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A buprenorphine and naloxone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include severe drowsiness, fainting, and slow breathing (breathing may stop).

What should I avoid while taking buprenorphine and naloxone?

Do not drink alcohol. Dangerous side effects or death could occur.

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how the medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Buprenorphine and naloxone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Like other narcotic medicines, buprenorphine and naloxone can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once or seek emergency medical attention if you have:

  • weak or shallow breathing, feeling like you might pass out;

  • confusion, loss of coordination, extreme weakness;

  • blurred vision, slurred speech;

  • adrenal gland problems--nausea, vomiting, loss of appetite, dizziness, feeling weak or tired;

  • high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  • liver problems--nausea, upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • withdrawal symptoms--diarrhea, vomiting, shaking or shivering, runny nose, watery eyes, muscle pain, and feeling very hot or cold.

Common side effects may include:

  • dizziness, drowsiness, blurred vision, feeling drunk;

  • tongue pain, redness or numbness inside your mouth;

  • constipation, mild nausea, vomiting;

  • headache, back pain, swelling in your hands or feet;

  • fast or pounding heartbeats, increased sweating; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Buprenorphine and naloxone dosing information

Usual Adult Dose for Opiate Dependence:

Buprenorphine monotherapy is generally used for induction; buprenorphine/naloxone sublingual film, Bunavail(R) buccal film and Zubsolv(R) sublingual tablet may be used for induction in patients dependent on heroin or short-acting opioid products.

All doses expressed as BUPRENORPHINE/NALOXONE

Sublingual Film:
INDUCTION dose:
-Day 1: Initial dose: 2 mg/0.5 mg or 4 mg/1 mg sublingually; followed in intervals of approximately 2 hours with additional doses of 2 mg/0.5 mg or 4 mg/1 mg to control acute withdrawal symptoms up to a total day 1 dose of 8 mg/2 mg
-Day 2: 16 mg/4 mg sublingually

Bunavail(R) Buccal Film:
INDUCTION dose:
-Day 1: Initial dose: 2.1 mg/0.3 mg buccally; followed in intervals of approximately 2 hours with additional doses to a total dose of 4.2 mg/0.7 mg to control acute withdrawal symptoms
-Day 2: a single dose up to 8.4 mg/1.4 mg buccally

Zubsolv(R) Sublingual Tablets:
INDUCTION dose:
-Day 1: Initial dose: 1.4 mg/0.36 mg sublingually; followed in intervals of 1.5 to 2 hours with additional doses of 1.4 mg/0.36 mg or 2.8 mg/0.72 mg to control acute withdrawal symptoms up to a total day 1 dose of 5.7 mg/1.4 mg (some patients with recent exposure to buprenorphine may tolerate up to 4.2 mg/1.08 mg as a single, second dose)
-Day 2: 11.4 mg/2.9 mg sublingually

Comments:
-To avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear, and no sooner than 6 hours after last use of heroin or other short-acting opioid.
-For patients dependent on methadone or long-acting opioid products, the presence of naloxone which may be absorbed in small amounts by the sublingual route, could precipitate or prolong withdrawal during the induction; buprenorphine monotherapy should be used during induction phase.
-Maintenance treatment begins on day 3.

MAINTENANCE Treatment:
-Doses of buprenorphine/naloxone should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.
-The following buprenorphine/naloxone products are available for maintenance treatment; these products are not bioequivalent and dose adjustments may be necessary when switching products:

SUBOXONE(R) Sublingual Film and Sublingual Tablets:
-Progressively adjust in increments/decrements of 2 mg/0.5 mg or 4 mg/1 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 16 mg/4 mg sublingually once a day; dose range 4 mg/1 mg to 24 mg/6 mg
-Maximum dose: 24 mg/6 mg sublingually once a day

ZUBSOLV(R) Sublingual Tablets:
-Progressively adjust in increments/decrements of 1.4 mg/0.36 mg or 2.9 mg/0.71 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 11.4 mg/2.9 mg sublingually once a day; dose range 2.9 mg/0.71 mg to 17.2 mg/4.2 mg
-Maximum dose: 17.2 mg/4.2 mg sublingually once a day

BUNAVAIL(R) Buccal Film: Bunavail(R) 4.2 mg/0.7 mg buccal film provides equivalent buprenorphine exposure as Suboxone(R) 8 mg/2 mg sublingual tablet.
-Progressively adjust in increments/decrements of 2.1 mg/0.3 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 8.4 mg/1.4 mg buccally once a day; range 2.1 mg/0.3 mg to 12.6 mg/2.1 mg
Maximum dose: 12.6 mg/ 2.1 mg buccally once a day

Use: For the treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

Usual Pediatric Dose for Opiate Dependence:

16 years or older:
Buprenorphine monotherapy is generally used for induction; buprenorphine/naloxone sublingual film and Zubsolv(R) sublingual tablet may be used for induction in patients dependent on heroin or short-acting opioid products.

All doses expressed as BUPRENORPHINE/NALOXONE

Sublingual Film:
INDUCTION dose:
-Day 1: Initial dose: 2 mg/0.5 mg or 4 mg/1 mg sublingually; followed in intervals of approximately 2 hours with additional doses of 2 mg/0.5 mg or 4 mg/1 mg to control acute withdrawal symptoms up to a total day 1 dose of 8 mg/2 mg
-Day 2: 16 mg/4 mg sublingually

Zubsolv(R) Sublingual Tablets:
INDUCTION dose:
-Day 1: Initial dose: 1.4 mg/0.36 mg sublingually; followed in intervals of 1.5 to 2 hours with additional doses of 1.4 mg/0.36 mg or 2.8 mg/0.72 mg to control acute withdrawal symptoms up to a total day 1 dose of 5.7 mg/1.4 mg (some patients with recent exposure to buprenorphine may tolerate up to 4.2 mg/1.08 mg as a single, second dose)
-Day 2: 11.4 mg/2.9 mg sublingually

Comments:
-To avoid precipitating withdrawal during induction, initiation should occur when clear signs of withdrawal are evident, preferably when moderate objective signs of opioid withdrawal appear, and no sooner than 6 hours after last use of heroin or other short-acting opioid.
-For patients dependent on methadone or long-acting opioid products, the presence of naloxone which may be absorbed in small amounts by the sublingual route, could precipitate or prolong withdrawal during the induction; buprenorphine monotherapy should be used during induction phase.
-Maintenance treatment begins on day 3.

MAINTENANCE Treatment:
-Doses of buprenorphine/naloxone should be adjusted to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms; doses should be titrated to clinical effectiveness as rapidly as possible as gradual titration may lead to higher drop-out rates.
-The following buprenorphine/naloxone products are available for maintenance treatment; these products are not bioequivalent and dose adjustments may be necessary when switching products:
SUBOXONE(R) Sublingual Film and Sublingual Tablets:
-Progressively adjust in increments/decrements of 2 mg/0.5 mg or 4 mg/1 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 16 mg/4 mg sublingually once a day; dose range 4 mg/1 mg to 24 mg/6 mg
-Maximum dose: 24 mg/6 mg sublingually once a day

ZUBSOLV(R) Sublingual Tablets:
-Progressively adjust in increments/decrements of 1.4 mg/0.36 mg or 2.9 mg/0.71 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 11.4 mg/2.9 mg sublingually once a day; dose range 2.9 mg/0.71 mg to 17.2 mg/4.2 mg
-Maximum dose: 17.2 mg/4.2 mg sublingually once a day

BUNAVAIL(R) Buccal Film: Bunavail(R) 4.2 mg/0.7 mg buccal film provides equivalent buprenorphine exposure as Suboxone(R) 8 mg/2 mg sublingual tablet.
-Progressively adjust in increments/decrements of 2.1 mg/0.3 mg to a level that holds the patient in treatment and suppresses opioid withdrawal signs and symptoms
-Recommended target dose: 8.4 mg/1.4 mg buccally once a day; range 2.1 mg/0.3 mg to 12.6 mg/2.1 mg
Maximum dose: 12.6 mg/ 2.1 mg buccally once a day

Use: For the treatment of opioid dependence as part of a complete treatment plan to include counseling and psychosocial support.

What other drugs will affect buprenorphine and naloxone?

Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

  • other narcotic medications--opioid pain medicine or prescription cough medicine;

  • drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or

  • drugs that affect serotonin levels in your body--medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

This list is not complete and many other drugs can interact with buprenorphine and naloxone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using. Give a list of all your medicines to any healthcare provider who treats you.

See also: Side effects (in more detail)

Where can I get more information?

  • Your pharmacist can provide more information about buprenorphine and naloxone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.12.

Date modified: September 05, 2017
Last reviewed: April 25, 2017

Hide