SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII)

Frequently
asked questions

Find a doctor who can provide treatment

Some questions you may have about treatment with SUBOXONE Film are answered below.

About treatment
What is the goal of treatment?

The overall goal of treatment is to end the abuse or misuse of opioids, and to try to help patients manage their condition. Each person’s case is different, and the doctor who treats your opioid dependence should work with you to create a treatment plan that fits your specific needs.

What is SUBOXONE Film?

SUBOXONE Film is a prescription medicine that contains the active ingredients buprenorphine and naloxone. It is used to treat adults who are dependent on (addicted to) opioids (either prescription or illegal).

SUBOXONE Film is indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.

Treatment should begin under the supervision of a doctor. The doctor must be qualified under the Drug Addiction Treatment Act of 2000 (DATA 2000). In appropriate patients, treatment may continue at home with follow-up visits to a doctor at reasonable intervals.

How may SUBOXONE Film treatment help?

Medication-assisted treatment with buprenorphine, one of the active ingredients in SUBOXONE Film, may help reduce the craving for opioids.

You can work with a doctor who is qualified to treat opioid dependence with FDA-approved medications to create a comprehensive treatment plan that includes SUBOXONE Film, counseling, and psychosocial support.

Getting ready for treatment
How do the ingredients in SUBOXONE Film work?

Watch this video for an overview.

SUBOXONE Film contains buprenorphine and naloxone.

When SUBOXONE Film is taken under the tongue or inside the cheek, buprenorphine travels through the bloodstream to the brain where it attaches to receptors called “mu opioid receptors.” The buprenorphine in SUBOXONE Film has a stronger bond with these receptors than most full opioid agonists (eg, heroin, hydrocodone, methadone, morphine, and oxycodone) at an equivalent dose. Because of its stronger bond, buprenorphine cannot be disturbed or moved by most full opioid agonists. Buprenorphine may help to suppress withdrawal symptoms.

The naloxone in SUBOXONE Film is called an “opioid antagonist” and it is included to help prevent misuse. If you are opioid dependent and attempt to take SUBOXONE Film other than per administration instructions, the naloxone may produce withdrawal symptoms.

Selected Safety Information:

Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE Film 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 drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

Am I just substituting one drug for another?

Medication-assisted treatment allows patients to receive prescription medication that may help suppress withdrawal symptoms and reduce cravings.

Medication-assisted treatment with buprenorphine, one of the active ingredients in SUBOXONE Film, may help reduce the craving for opioids. SUBOXONE Film along with counseling and psychosocial support may help you—or someone you care about—manage opioid dependence.

Selected Safety Information:

Before taking SUBOXONE Film, tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant or become pregnant while taking SUBOXONE Film, alert your doctor immediately and you should report it to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

What is Induction?

Induction, or starting treatment, is the first phase of medication-assisted treatment.

SUBOXONE Film is approved for use in both induction and maintenance treatment of opioid dependence in appropriate patients.*

  • For dependence on short-acting opioids, like heroin or prescription painkillers, SUBOXONE Film, which contains buprenorphine and naloxone, may be recommended to help you begin and maintain continuity of treatment
  • When transitioning from dependence on long-acting opioids, like methadone, a buprenorphine-only medication may be recommended

For your first dose, you must be in a moderate state of withdrawal. Your doctor will give you your first dose of SUBOXONE Film, which can be adjusted if you are still not feeling relief. Your doctor may give you instructions and a prescription that will last until your next appointment, usually within the next few days. Your doctor may also want to discuss counseling or behavioral therapy as part of your complete treatment plan.

You work with your doctor to reach a dose of SUBOXONE Film that works for you. Your doctor may transition you to the maintenance phase of treatment when you:

  • Are no longer experiencing withdrawal symptoms
  • Have minimal to no side effects
  • Do not have uncontrollable cravings

Please see the "Stages of treatment" section for more details about induction.

Selected Safety Information:

Your doctor may monitor liver function before and during treatment.

*SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Film may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone.

How do I know when I am taking the right dose?

Your doctor should monitor your progress. It’s important to let your doctor know about any withdrawal symptoms or cravings you experience, so you can work together to determine whether you may benefit from a change in your dose or from additional counseling services. Please see the Medication Guide for more information.

SUBOXONE Film comes in 4 dosage strengths: 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg doses.

What are some of the possible side effects?

Contact your doctor if you have or may have:

  • Trouble breathing. You have a higher risk of death and coma if you take SUBOXONE with other medicines, such as benzodiazepines.
  • Sleepiness, dizziness, and problems with coordination
  • Dependency or abuse
  • Liver problems. Call your doctor right away if you notice any of these signs of liver problems: Your skin or the white part of your eyes turning yellow (jaundice), urine turning dark, stools turning light in color, you have less of an appetite, or you have stomach (abdominal) pain or nausea. Your doctor should do tests before you start taking and while you take SUBOXONE.
  • Allergic reaction. You may have a rash, hives, swelling of the face, wheezing, or a loss of blood pressure and consciousness. Call a doctor or get emergency help right away.
  • Opioid withdrawal. This can include: shaking, sweating more than normal, feeling hot or cold more than normal, runny nose, watery eyes, goose bumps, diarrhea, vomiting, and muscle aches. Tell your doctor if you develop any of these symptoms.
  • Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.

Common side effects of SUBOXONE Sublingual Film include:

  • Nausea
  • Vomiting
  • Drug withdrawal syndrome
  • Headache
  • Sweating
  • Numb mouth
  • Constipation
  • Painful tongue
  • The inside of your mouth is redder than normal
  • Intoxication (feeling lightheaded or drunk)
  • Disturbance in attention
  • Irregular heartbeat (palpitations)
  • Trouble sleeping (insomnia)
  • Blurred vision
  • Back pain
  • Fainting
  • Dizziness
  • Sleepiness

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of SUBOXONE Sublingual Film. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see Full Prescribing Information and Medication Guide for SUBOXONE Film.

For more information on adverse events click here.

What happens if someone takes SUBOXONE Film at the same time as another opioid?

It depends on which was taken first. If someone who is taking SUBOXONE Film as prescribed takes another opioid, then, at the right dose, the buprenorphine in the SUBOXONE Film may help block the effect of the other opioid.

If someone who is actively using other opioids takes SUBOXONE Film, the SUBOXONE Film may cause sudden and severe ("precipitated") withdrawal. (See "Why do I need to be in withdrawal when I start my treatment?" for more information).

Selected Safety Information:

SUBOXONE Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Film.

Can people become addicted to buprenorphine?

Yes. Buprenorphine—one of the active ingredients in SUBOXONE Film—is an opioid, and all opioids have the potential to cause physical dependence or addiction. Unlike opioid prescription painkillers and heroin, which are "full opioid agonists," buprenorphine is a "partial opioid agonist." That means that the buprenorphine in SUBOXONE Film attaches to the same receptors in the brain that the other opioids attach to, but it produces less euphoria than a full opioid agonist. Even though it only produces a partial effect, it should be sufficient to suppress withdrawal symptoms including cravings.

Selected Safety Information

SUBOXONE Film 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 drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

What is the Here to Help® Program and how do I sign up?

The Here to Help® Program is another resource for people in treatment with SUBOXONE Film. These brief emails will provide information about treatment and other occasional updates.

Treatment with SUBOXONE Film
What happens during maintenance treatment?

During the maintenance phase of treatment you should be taking your medication as prescribed. Your complete treatment plan should include counseling and behavioral therapy.

The recommended target dosage of SUBOXONE Film during maintenance is 16 mg/4 mg as a single daily dose. The maintenance dose may range from 4 mg/1 mg to 24 mg/6 mg depending on the individual patient and clinical response.

How should I take SUBOXONE Film?

Always take your medication exactly as prescribed by your doctor. See the Medication Guide that accompanies your prescription for full instructions. Call your doctor’s office with any questions.

Watch the video or see the Medication Guide to see how to take SUBOXONE Film. If you have any questions, talk with your doctor.

Do not stop taking SUBOXONE Film suddenly. You could become sick and have withdrawal symptoms because your body has become used to the medicine. Ask your doctor how to stop using SUBOXONE Film the right way.

If you take too much SUBOXONE Film or overdose, get emergency medical help right away.

Selected Safety Information
Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe breathing problems and death.

Please see Full Prescribing Information and Medication Guide for SUBOXONE Film.

Can I take too much SUBOXONE Film?

Yes. It is important to take SUBOXONE Film exactly as prescribed by your doctor. If you take too much SUBOXONE Film or overdose, get emergency medical help right away.

Patients who feel that they need a higher or lower dose than prescribed should talk with their doctor about their concern, and should follow their doctor's instructions.

Sometimes the doses of certain medications and SUBOXONE Film may need to be changed if used together. Do not take any medicine while using SUBOXONE Film until you have talked with your doctor.

Selected Safety Information:
SUBOXONE Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Film.

What's the best time to take SUBOXONE Film?

You should take SUBOXONE Film once-daily at the same time every day. If you miss a dose of SUBOXONE Film, you should take it as soon as you remember. If it is almost time for the next dose, you should skip the missed dose and take the next dose at the regular time.

How should I dispose of unused SUBOXONE Film?

Dispose of unused SUBOXONE Films as soon as you no longer need them.

Unused films should be removed from the foil pouch and flushed down the toilet.

Selected Safety Information:
Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe breathing problems and death.

What happens if I stop taking SUBOXONE Film?

Do not stop taking SUBOXONE Film 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.

What if I've relapsed?

Get in touch with your doctor right away. Your counselor may also be able to help.

Relapse does not have to mean treatment failure. The chronic nature of opioid dependence means that relapsing to drug use may occur. The most important thing is to seek treatment.

When should I stop treatment?

The length of treatment can vary from patient to patient. The decision to discontinue therapy with SUBOXONE Film after a period of maintenance should be made as part of a comprehensive treatment plan. It is up to you, your doctor, and your therapist or counselor to decide on the appropriate length of treatment. If you and your treatment team agree that the time is right, your doctor has the option either to lower your dose over time, or to abruptly discontinue SUBOXONE Film under medical supervision.

Selected Safety Information:
SUBOXONE Film 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 drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

What happens if a child puts SUBOXONE Film in his or her mouth by accident?

Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe, possibly fatal, respiratory depression. Emergency medical care is critical. Get emergency help right away.

Selected Safety Information:
Keep SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe breathing problems and death.

What happens if an adult takes SUBOXONE Film by accident?

Buprenorphine, one of the active ingredients in SUBOXONE Film, has been associated with significant respiratory depression and death.

Buprenorphine can cause adverse reactions similar to other opioids, including slowed breathing and other symptoms that need to be assessed and monitored medically. Seek medical attention immediately.

It's important to know that combining buprenorphine with other drugs or medications, such as benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol can be fatal.

You should know: There have been reported deaths of opioid naive individuals who received a 2 mg/0.5 mg dose of buprenorphine as a sublingual tablet for analgesia.

Please see Full Prescribing Information and Medication Guide for SUBOXONE Film

Find a doctor who
can provide treatment.

Important Safety Information

Indication

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of physicians qualified under the Drug Addiction Treatment Act.

Important Safety Information

Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone as serious negative effects, including anaphylactic shock, have been reported.

SUBOXONE Film can be abused in a manner similar to other opioids, legal or illicit.

SUBOXONE Film 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 drug addiction. Do not stop taking SUBOXONE Film suddenly without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

SUBOXONE Film can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines or other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is extremely dangerous to take nonprescribed benzodiazepines or other medications that act on the nervous system while taking SUBOXONE Film.

You should not drink alcohol while taking SUBOXONE Film, as this can lead to loss of consciousness or even death.

Death has been reported in those who are not opioid dependent.

Your doctor may monitor liver function before and during treatment.

SUBOXONE Film is not recommended in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, SUBOXONE Film 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 SUBOXONE Film out of the sight and reach of children. Accidental or deliberate ingestion of SUBOXONE Film by a child can cause severe breathing problems and death.

Do not take SUBOXONE Film before the effects of other opioids (eg, heroin, hydrocodone, methadone, morphine, oxycodone) have subsided as you may experience withdrawal symptoms.

Injecting the SUBOXONE Film product may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

Before taking SUBOXONE Film, tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant or become pregnant while taking SUBOXONE Film, alert your doctor immediately and you should report it using the contact information provided below.*

Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit. Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized and treated in the neonate. Healthcare professionals should observe newborns for signs of NOWS and manage accordingly.

Before taking SUBOXONE Film, talk to your doctor if you are breastfeeding or plan to breastfeed your baby. The active ingredients of SUBOXONE Film can pass into your breast milk. You and your doctor should consider the development and health benefits of breastfeeding along with your clinical need for SUBOXONE Film and should also consider any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how SUBOXONE Film affects you. Buprenorphine in SUBOXONE Film can cause drowsiness and slow reaction times during dose-adjustment periods.

Common side effects of SUBOXONE Film include nausea, vomiting, drug withdrawal syndrome, headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth, intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat, decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.

This is not a complete list of potential adverse events associated with SUBOXONE Film. Please see full Prescribing Information for a complete list.

*To report negative side effects associated with taking SUBOXONE Film, please call 1-877-782-6966. 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 SUBOXONE Film, SUBOXONE® (buprenorphine and naloxone) Sublingual Tablets (CIII), or SUBUTEX® (buprenorphine) Sublingual Tablets (CIII), please see the respective full Prescribing Information and Medication Guide at www.suboxoneREMS.com.

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IMPORTANT SAFETY INFORMATION AND INDICATION

SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine indicated for treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.