asked questions about BUNAVAIL

BUNAVAIL contains buprenorphine, the same medicine found in other medications designed for the treatment of opioid dependence.

Unlike some medications patients may take for opioid dependence, BUNAVAIL is not administered under the tongue. It is the only medication that uses special film technology to stick to the inside of the cheek to deliver buprenorphine. It’s discreet so no one knows your patients are taking it, and they can speak and swallow normally as it dissolves.

The unique technology in BUNAVAIL includes a backing layer, which helps to direct medication into the bloodstream and stop it from flowing back into the mouth where it could be swallowed. In fact, with BUNAVAIL, patients get the same amount of medication as they do with Suboxone but from a smaller total dose.

BUNAVAIL is called a buccal film because it adheres to the buccal mucosa. So, rather than your patients holding BUNAVAIL under the tongue, it sticks to the inside of the cheek.

BUNAVAIL buccal film is made of 2 layers: the top layer and the backing layer. The top layer contains the dose of buprenorphine. It sticks to the inside of the cheek and begins to deliver medication right away. The backing layer helps direct the flow of buprenorphine into the bloodstream and stops some of it from flowing back into the mouth where it might be swallowed.

The 2 layers in BUNAVAIL buccal film allow for a more efficient delivery of medication. In the end, patients get the same effect as they would from Suboxone from half the amount of buprenorphine.

As the BUNAVAIL film dissolves, it will remain fixed to the cheek so patients can speak and swallow normally.

BUNAVAIL has about half the overall dose of Suboxone because its unique route of administration and 2-layer design allows it to deliver buprenorphine more efficiently. The same amount of buprenorphine gets into the bloodstream through the cheek and less flows back into the mouth where it could be swallowed.

As a result, BUNAVAIL can be given as a lower dose while giving patients the same amount of buprenorphine as Suboxone.

The side of the film with the dose strength, eg, BN4, printed on it should be placed against their cheek. This side of the film is designed to stick to the cheek when it comes into contact with moisture and delivers buprenorphine as it dissolves.

If your patients encounter any problems while applying BUNAVAIL, don’t panic. First, tell them to readjust the film on their finger and try to reapply the film to the inside of their cheek. If the film won’t adhere, properly dispose of it and try again with a new film. Remember to make sure their mouth is moist.

Tell your patients to try to not get frustrated if their first few attempts at applying BUNAVAIL feel awkward; they’ll get used to it with some practice. They should try it with the practice films included in their starter kit, and ask you for more practice films as needed.

Some patients say that BUNAVAIL film feels sticky or gummy as it dissolves. This can be considered normal and is due to the materials in BUNAVAIL that cause it to stick to the inside of the cheek and efficiently deliver buprenorphine into the bloodstream.

BUNAVAIL begins to dissolve as soon as it’s placed against the inside of the cheek. The time it takes to dissolve varies by person. Patients should leave the BUNAVAIL film in their mouth until it is fully dissolved.

During this time, they can speak and swallow normally and interact with others without them knowing they’re taking their medication.

The BUNAVAIL film is made of 2 layers, each with a different thickness. The backing layer is thicker than the top layer and since it’s thicker, it will take more time to dissolve. This design allows the backing layer to stop some of the buprenorphine from flowing back into the mouth where it can be swallowed.

Patients can speak and swallow normally while taking BUNAVAIL. However, they shouldn’t eat or drink as that may cause the film to come off their cheek before it’s fully dissolved.

Patients should not drink alcohol while using BUNAVAIL, as this can lead to loss of consciousness or even death.

There are no restrictions regarding smoking when taking BUNAVAIL.

BUNAVAIL should be applied comfortably to the middle of the inside of the cheek. Once BUNAVAIL adheres, patients should try to not play with it with their tongue as this can cause the film to move. As they continue to apply BUNAVAIL, they’ll find a spot that works best for them.

If your patient is applying more than one film at a time, make sure they put them on opposite cheeks.

BUNAVAIL is a maintenance medication. That means it should be taken on a regular basis for the treatment of opioid dependence. Patients should work with you on coming up with a treatment plan that’s right for them. Make sure they take BUNAVAIL as prescribed.

Your patient should continue to take their medication as prescribed and call you to discuss their symptoms.

In a scientific study, 249 people who took Suboxone switched to BUNAVAIL for 12 weeks. Before they switched to BUNAVAIL, up to 6.8% of people had oral abnormalities over 2 examinations. During the 12 weeks of the study, researchers conducted more than 1000 examinations of people’s mouths. They found that 2.4% of people had an oral abnormality, but no abnormalities were seen in the last 4 weeks of the study.

If your patients do experience any side effects, they should call you right away.

The BUNAVAIL Savings Program is available to help eligible patients pay for their medication. Whether they have commercial insurance or are paying out of pocket for their medication, the BUNAVAIL Savings Program can help reduce the cost of their medication.

Visit for more information and to print a savings card.

Relative bioavailability determined with Suboxone tablets.

If your patient places the wrong side of the film against their cheek, BUNAVAIL will not adhere.

  1. BUNAVAIL® [prescribing information]. Raleigh, NC: BioDelivery Sciences International, Inc; 2015.
  2. Vasisht N, Stark J, Bai SA, Finn A. Buprenorphine/naloxone buccal film has a relative buprenorphine bioavailability approximately twice that of buprenorphine/naloxone sublingual tablet. Poster presented at: 45th Annual American Society of Addiction Medicine (ASAM); April 10-13, 2014; Orlando, FL.



BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is a prescription medicine indicated for the maintenance treatment of opioid dependence. BUNAVAIL should be used as part of a complete treatment plan to include counseling and psychosocial support.

Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).


Keep BUNAVAIL (buprenorphine and naloxone) buccal film (CIII) out of the sight and reach of children. Ingestion of BUNAVAIL by a child may cause severe breathing problems and death. If a child takes BUNAVAIL, get emergency help right away.

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

Do not take BUNAVAIL before the effects of other opioids (e.g., heroin, methadone, oxycodone, morphine) have lessened as you may experience withdrawal symptoms.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how BUNAVAIL affects you.

BUNAVAIL contains buprenorphine, an opioid that can cause physical dependence. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking BUNAVAIL without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

Do not switch from BUNAVAIL to other medicines that contain buprenorphine without talking with your doctor. The amount of buprenorphine in a dose of BUNAVAIL is not the same as the amount of buprenorphine in other medicines. Your doctor will prescribe a dose of BUNAVAIL that may be different than other buprenorphine-containing medicines you may have been taking.

BUNAVAIL can cause serious life-threatening breathing problems, overdose and death, particularly when taken by the intravenous (IV) route in combination with benzodiazepines, sedatives, tranquilizers or alcohol. You should not drink alcohol while taking BUNAVAIL, as this can lead to loss of consciousness or even death.

Like other opioids (e.g., heroin, methadone, oxycodone, morphine), BUNAVAIL may produce orthostatic hypotension ('dizzy spells') in ambulatory individuals.

Common side effects of BUNAVAIL include headache, drug withdrawal syndrome, lethargy (lack of energy), sweating, constipation, decrease in sleep (insomnia), fatigue and sleepiness.

Because BUNAVAIL contains naloxone, injecting BUNAVAIL may cause serious withdrawal symptoms such as pain, cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.

BUNAVAIL can be abused in a manner similar to other opioids, legal or illicit. Keep BUNAVAIL in a safe place. Do not give your BUNAVAIL to other people, it can cause them harm or even death. Selling or giving away this medicine is against the law.

BUNAVAIL is not recommended in patients with severe hepatic impairment. BUNAVAIL may be used with caution for maintenance treatment in patients with moderate hepatic impairment.

Before taking BUNAVAIL, tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking BUNAVAIL, tell your doctor immediately as there may be significant risks to you and your baby; your baby may have symptoms of withdrawal at birth.

Before taking BUNAVAIL, talk to your doctor if you are breast-feeding or plan to breast-feed your baby. BUNAVAIL can pass into your breast milk and may harm your baby. Monitor your baby for increased sleepiness and breathing problems. Your doctor should tell you about the best way to feed your baby if you are taking BUNAVAIL.

This is not a complete list of potential adverse events associated with BUNAVAIL buccal film. Please see full Prescribing Information for a complete list.

To report negative side effects associated with taking BUNAVAIL buccal film, please call 1-800-469-0261. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.

For more information, please see full Prescribing Information and Medication Guide for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII).



BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII) is a prescription medicine indicated for the maintenance treatment of opioid dependence. BUNAVAIL should be used as part of a complete treatment plan to include counseling and psychosocial support.