buprenorphine / naloxone
Suboxone film (buprenorphine / naloxone) is used for treating opioid use disorder (OUD) in adults. This medication-assisted treatment is given along with counseling and social and emotional support. Suboxone film is a combination of two medications: buprenorphine (a partial opioid agonist) and naloxone (an opioid antagonist). The films are dissolved either under the tongue (sublingually) or against the inside of the cheek (buccally). The medication is taken once per day. Side effects include numbness in the mouth and headache. It's a controlled substance because it has a risk of being addictive and being misused.
What is Suboxone film (buprenorphine / naloxone)?
What is Suboxone film (buprenorphine / naloxone) used for?
Treatment of opioid use disorder (OUD) in adults (in addition to counseling and therapy)
How Suboxone film (buprenorphine / naloxone) works
Suboxone film (buprenorphine / naloxone) is a combination of two medications that work together to treat opioid use disorder.
Buprenorphine is a partial opioid agonist. It works by attaching to opioid receptors in the brain similar to other opioid medications. But buprenorphine doesn't turn on these receptors as strongly as other opioids. This helps ease opioid cravings and lessen the risk for withdrawal symptoms in someone with opioid use disorder without causing the same "high" as other opioid medications.
Naloxone is an opioid antagonist. It blocks the opioid receptors in your brain. Naloxone doesn't affect the actions of buprenorphine when Suboxone film (buprenorphine / naloxone) is dissolved on the tongue. But it will block the effects of buprenorphine and cause withdrawal symptoms if Suboxone film (buprenorphine / naloxone) were to be misused by injection or by other ways. This is meant to prevent people from misusing buprenorphine.
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What are the risks and warnings for Suboxone film (buprenorphine / naloxone)?
Suboxone film (buprenorphine / naloxone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Potential for addiction and misuse
Risk factors: History of alcohol or substance use disorder | Taking more Suboxone film (buprenorphine / naloxone) than prescribed
Suboxone is a schedule III controlled substance because it contains the opioid buprenorphine. Buprenorphine has a risk for misuse and dependence. Misusing Suboxone film (buprenorphine / naloxone) can raise the risk for addiction and other serious side effects, such as dangerously slow breathing and overdose. Take Suboxone film (buprenorphine / naloxone) exactly as prescribed. Don't change how much you take or how often you take it without talking to your prescriber first.
Potentially life-threatening slowed breathing (respiratory depression)
Risk factors: Age 65 years or older | Chronic obstructive pulmonary disease (COPD) | Other medical conditions that cause or raise the risk for slow breathing | Taking sedatives or other medications that can slow down breathing | Drinking alcohol
Suboxone contains buprenorphine, which can cause dangerously slow breathing. This can be life-threatening. Your risk is higher if you take other medications that can slow your body down like benzodiazepines and opioids. Drinking alcohol with Suboxone film (buprenorphine / naloxone) also raises your risk for slowed breathing. In addition, people getting treated for opioid use disorder can sometimes relapse, which puts them at high risk for breathing problems from opioid use.
Your prescriber might recommend that you always have naloxone (Narcan) with you in case you need to quickly treat any slowed breathing from Suboxone film (buprenorphine / naloxone) or other opioids. It's important for you and your loved ones to know how to use naloxone (Narcan) if you start breathing extremely slowly. Give naloxone (Narcan) and call 911 right away if you or a loved one notices that you're having trouble breathing or that you have bluish-colored lips.
Risk for opioid overdose
Risk factors: History of opioid use disorder | Previous opioid overdose | Taking high opioid doses | Taking more opioids than prescribed | Taking sedatives or other medications that can cause slowed breathing | Drinking alcohol | Age 65 years and older | Age 18 years and younger
People who are getting treated for opioid use disorder are at risk for relapse, meaning that they can fall back into taking opioids again. In general, opioids have a risk for causing overdose. An opioid overdose can happen at recommended doses of opioids. It can also happen if you take higher doses than prescribed or take the medication more often than prescribed. What's more, a fatal overdose can happen in children if they accidentally take just one dose of an opioid medication like Suboxone film (buprenorphine / naloxone).
Opioid overdoses can be life-threatening if it's not recognized or treated in time. Overdose symptoms include extremely slowed breathing, slow heartbeat, extreme sleepiness, cold or clammy skin, or not responding to sound or touch. Call 911 right away if you think an overdose has happened.
Your prescriber might suggest to always carry naloxone (Narcan), a medication that's used to help reverse life-threatening opioid overdose. It's important for you and your loved ones to know when and how to use naloxone (Narcan) in case an accidental overdose happens. Store your medications out of reach from children, pets, and visitors.
Difficulty concentrating and extreme sleepiness
Risk factors: Age 65 years and older | Taking other medications that make you less alert or slow your body down | Drinking alcohol
Suboxone film (buprenorphine / naloxone) can cause extreme sleepiness. It can also lower your ability to think, react, and focus. Drinking alcohol and taking other medications that slow your body down, like benzodiazepines, sedatives, and muscle relaxants, can worsen these side effects.
Make sure you know how Suboxone film (buprenorphine / naloxone) affects you before driving a car or doing activities that require your concentration. Avoid drinking alcohol or taking medications that make you sleepy while you're taking Suboxone film (buprenorphine / naloxone). Talk to your care team right away if you feel too sleepy from taking Suboxone film (buprenorphine / naloxone).
Harm to newborn babies
Risk factors: Taking Suboxone film (buprenorphine / naloxone) during pregnancy
During pregnancy, opioids can travel through your bloodstream to your unborn baby. Long-term opioid use during pregnancy can cause your unborn baby to become dependent on the medication.
Once your baby is born, they can experience withdrawal symptoms, including high-pitched crying, poor feeding and sucking behavior, trembling, irritability, abnormal sleep patterns, and even seizures. This condition is called neonatal opioid withdrawal syndrome and can be life-threatening if not recognized and treated in time. Let your healthcare team know if you've taken Suboxone film (buprenorphine / naloxone) during pregnancy and if you notice your newborn having these withdrawal symptoms.
Low adrenal hormone levels
Risk factors: Taking Suboxone film (buprenorphine / naloxone) for longer than 1 month
Some people who take medications containing opioids, like Suboxone film (buprenorphine / naloxone), can have a drop in their adrenal hormone levels. This is more likely if people take the medication for longer than 1 month. Let your prescriber know right away if you have symptoms of low adrenal hormones, including nausea, vomiting, not feeling hungry, tiredness, dizziness, and weakness. You might need to work with your prescriber to stop Suboxone film (buprenorphine / naloxone) and then get treated with corticosteroids.
Withdrawal symptoms
Risk factors: Long-term use of Suboxone film (buprenorphine / naloxone) or other opioids | Stopping or lowering the dose of Suboxone film (buprenorphine / naloxone) suddenly | Starting Suboxone film (buprenorphine / naloxone) before the full effect of other opioids have worn off | Liver damage
Taking Suboxone film (buprenorphine / naloxone) for a long period of time can cause physical dependence. This means that your body relies on the medication to function and you can experience withdrawal if you lower the dose too quickly or stop taking the medication suddenly. Withdrawal symptoms include anxiety, restlessness, irritability, cravings, runny nose, yawning, sweating, chills, and body aches.
Withdrawal can also happen if you take Suboxone film (buprenorphine / naloxone) before the effects of any other opioids have worn off. In addition, misusing Suboxone film (buprenorphine / naloxone) by self-injection can lead to withdrawal symptoms in people who are physically dependent on other opioids.
It's important that you take Suboxone film (buprenorphine / naloxone) exactly as prescribed. Don't lower your dose or stop taking the medication suddenly without talking to your prescriber. They will slowly lower your dose to prevent withdrawal symptoms.
Liver damage
Risk factors: History of liver damage | Hepatitis B or C infection | Taking other medications that can cause liver damage | Injection drug use
Some people who've taken buprenorphine-containing medications developed liver damage. This damage can range from mild to severe and life-threatening (liver failure). You'll need to get blood tests done before you start taking Suboxone film (buprenorphine / naloxone) and periodically during treatment to make sure your liver is healthy.
It's not recommended for people with moderate-to-severe liver conditions to take Suboxone film (buprenorphine / naloxone). Liver damage lowers your body's ability to clear naloxone from your system, much more so than buprenorphine. This can make the levels of naloxone in your body to rise and lead to withdrawal symptoms when you first start Suboxone film (buprenorphine / naloxone). Talk to your prescriber about other options that can help with your opioid dependence if you have liver problems.
Dental problems
Some people who took buprenorphine-containing medications that are dissolved in the mouth have had dental problems. These problems included cavities, tooth infections, damaged teeth, and even tooth loss.
Be sure to get regular dental cleanings and check-ups with your dentist. Practice good oral hygiene, and brush your teeth and floss every day. After Suboxone film (buprenorphine / naloxone) dissolves under the tongue, swish some water around in your mouth and then swallow. Make sure to wait at least 1 hour after you take Suboxone film (buprenorphine / naloxone) before you brush your teeth.
Life-threatening heart rhythm problem (QT prolongation)
Risk factors: Heart rhythm problems | Heart failure | Electrolyte levels that aren't balanced in the body
Suboxone contains buprenorphine, which can cause QT prolongation (the time it takes for the heart to relax and contract again is longer than usual). This can potentially lead to a dangerous heart rhythm problem.
Tell your prescriber about your full medical history before you start taking Suboxone film (buprenorphine / naloxone). Your risk for QT prolongation might be higher if you already have heart problems or if you have abnormal electrolyte levels in your body. Contact your prescriber if you have symptoms of heart problems, such as pounding chest, trouble breathing, feeling faint or lightheaded, or chest pain, while you're taking this medication.
Low blood pressure
Suboxone film (buprenorphine / naloxone) can cause extremely low blood pressure. Your blood pressure might drop when you stand from a sitting or lying down position. This can lead to dizziness and fainting. To avoid falling, get up slowly if you've been sitting or lying down. Talk to your HCP if any dizziness or lightheadedness doesn't go away.
Not for use for pain or for people who haven't taken opioids before
Fatal overdoses have happened when people who haven't taken opioids before took a buprenorphine tablet for pain. Suboxone film (buprenorphine / naloxone) is only for people who've taken opioids before. Suboxone film (buprenorphine / naloxone) isn't meant to be taken as a pain reliever.
What are the side effects of Suboxone film (buprenorphine / naloxone)?
Common Side Effects
- Headache (36%)
- Withdrawal symptoms, such as anxiety, goosebumps, stomach discomfort, irritability, cold sweat, joint pain, and watery eyes (25%)
- General pain (22%)
- Nausea (15%)
- Sweating (14%)
- Trouble sleeping (14%)
- Constipation (12%)
- Stomach pain (11%)
Other Side Effects
- Dizziness or lightheadedness
- Mouth numbness
- Burning sensation in the mouth or tongue
- Reddening or swelling inside the mouth
- Swelling in the hands or ankles
- Body weakness
- Back pain
- Chills
- Runny nose
- Blurry vision
- Diarrhea
- Vomiting
- A racing heart
- Infection
Serious Side Effects
- Opioid withdrawal: anxiety, restlessness, irritability, muscle or joint aches, nausea, vomiting, sweating, chills, shaking, sleep problems
- Dangerously slow breathing: trouble breathing; bluish-colored lips, fingers, or toes
- Heart rhythm problems: chest pounding, chest pain, fluttering in the chest, trouble breathing, feeling faint or lightheaded
- Serious allergic reaction: rash; hives; itchiness; fast heartbeat; dizziness; trouble breathing; swelling of lips, mouth, or around the eyes
Source: DailyMed
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The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Constipation
- Dizziness
- Drowsiness
- Dry mouth
- Headache
- Nausea
- Vomiting
Pros and cons of Suboxone film (buprenorphine / naloxone)
Pros
Comes as a film that's placed under the tongue or against the inside of the cheek and dissolved
Available as a lower-cost generic
Cons
Has a risk of addiction and misuse (even though it helps treat opioid use disorder)
Is a controlled substance, so there are special requirements for filling a prescription
Pharmacist tips for Suboxone film (buprenorphine / naloxone)
Suboxone film (buprenorphine / naloxone) is typically given as part of a treatment plan with counseling and therapy for the best results. Discuss with your healthcare team about additional resources to help with your opioid dependence.
Take Suboxone film (buprenorphine / naloxone) exactly as prescribed. Never lower your dose or stop taking the medication suddenly without talking to your prescriber first. Your prescriber will need to lower your dose over a period of time to prevent withdrawal symptoms like shaking, nausea, muscle aches, irritability, and anxiety.
Practice good oral hygiene and go to your dental cleanings as recommended. Since Suboxone film (buprenorphine / naloxone) is placed under your tongue or against the inside of your cheek, the medication can cause problems with your teeth.
Let your care team know about all of the medications you're taking so they can check that your medications are safe to take together. Taking Suboxone film (buprenorphine / naloxone) together with benzodiazepines, sedatives, or alcohol can make side effects like slow breathing and severe sleepiness more intense. This can be life-threatening.
If you need to take pain medications, make sure to tell your prescriber that you're taking Suboxone film (buprenorphine / naloxone) so they can choose a safe treatment option for you. It's recommended that you first try non-opioid medications to relieve pain. Taking an opioid medication with Suboxone film (buprenorphine / naloxone) can put you at risk for serious side effects, such as sleepiness and breathing problems.
To lower the risk for an accidental overdose and to help prevent misuse, keep Suboxone film (buprenorphine / naloxone) in a safe place out of reach from children, pets, and visitors. If you don't need to take the medication anymore, get rid of it through a take-back program or flush it down the toilet after you remove the films from the package.
Never cut, chew, or swallow Suboxone film (buprenorphine / naloxone).
Drink a little water before you take the medication to help the film dissolve.
Taking Suboxone films under the tongue (sublingually): Place 1 film under the tongue, close to the back on the left or right side. If you need 2 films at the same time, place the second film under the tongue on the opposite side from the first. Avoid overlapping the films as much as possible. Keep the film(s) in place until it's completely dissolved. If you need 3 films at the same time, place the third film under the tongue on either side after the first 2 films have dissolved.
Taking Suboxone films against the cheek (buccally): Place 1 film against the inside of the left or right cheek. If you need 2 films at the same time, place the second film on the opposite cheek from the first. Keep the film against the inside of the cheek until it completely dissolves. If you need 3 films at the same time, place the third film against the inside of the cheek on either side after the first 2 films have dissolved.
As the film dissolves, don't chew or swallow the medication. Also avoid talking or eating or drinking anything until the film completely dissolves. This makes sure that all the medication gets absorbed and that it works as best as it can.
Once the film has dissolved all the way, gently rinse your water with some water and swallow to lower the risk for damage to your teeth.
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Suboxone film (buprenorphine / naloxone) dosage forms
Typical dosing for Suboxone film (buprenorphine / naloxone)
In general, your prescriber will work with you to adjust the dose of your medications for opioid use disorder based on your individual needs.
Suboxone film (buprenorphine / naloxone) is placed under the tongue (sublingual) or against the inside of the cheek (buccal). The film dissolves on its own.
Day 1: You'll typically start with films that contain either 2 mg/0.5 mg (buprenorphine/naloxone) or 4 mg/1 mg (buprenorphine/naloxone). The typical starting dose is 1 film as a single dose, then 1 to 2 films every 2 hours until you reach a total dose of 8 mg/2 mg (buprenorphine/naloxone) for day 1.
Day 2: The typical dose is up to 16 mg/4 mg (buprenorphine/naloxone) as a single dose.
Day 3 and onwards: Your prescriber will continue to adjust your dose until you reach a maintenance dose. The recommended target dose for maintenance is 16 mg/4 mg (buprenorphine/naloxone) once per day.
How much does Suboxone film (buprenorphine / naloxone) cost?
Suboxone film (buprenorphine / naloxone) contraindications
Severe allergy to buprenorphine or naloxone
What are alternatives to Suboxone film (buprenorphine / naloxone)?
Treatment of opioid use disorder (OUD) in adults (in addition to counseling and therapy)
Treatment of opioid use disorder (OUD) in adults (in addition to counseling and therapy)
Maintenance treatment for opioid use disorder (OUD) in adults (together with counseling and therapy)
What is the latest news about Suboxone film (buprenorphine / naloxone)?
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References
Best studies we foundCenters for Disease Control and Prevention. (2024). About opioid use during pregnancy.
Centers for Disease Control and Prevention. (2024). Oral health tips for adults.
Gunderson, E. W., et al. (2016). Efficacy of buprenorphine/naloxone rapidly dissolving sublingual tablets (BNX-RDT) after switching from BNX sublingual film. Journal of Addiction Medicine.
Indivior Inc. (2023). Suboxone- buprenorphine hydrochloride, naloxone hydrochloride film, soluble [package insert]. DailyMed.
MedlinePlus. (2023). Drug use and addiction.
MedlinePlus. (2023). Prescription drug misuse.
MedlinePlus. (2024). Opiate and opioid withdrawal.
National Institute of Dental and Craniofacial Research. (2024). Oral hygiene.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Symptoms & causes of adrenal insufficiency & Addison's disease.
U.S. Food and Drug Administration. (2022). FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain.
U.S. Food and Drug Administration. (2024). Drug disposal: Drug take-back options.
U.S. Food and Drug Administration. (2022). Medication guide: Suboxone (Sub-OX-own) buprenorphine and naloxone) sublingual film, CIII.
Velander, J. R. (2018). Suboxone: Rationale, science, misconceptions. Ochsner Journal.
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