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Description

Generic Name

Buprenorphine and naloxone

Active Ingredients

• Buprenorphine (as buprenorphine hydrochloride) – a partial opioid agonist
• Naloxone (as naloxone hydrochloride dihydrate) – an opioid antagonist

Chemical Composition

Buprenorphine hydrochloride is chemically described as 17-(cyclopropylmethyl)-α-(1,1-dimethylethyl)-4,5-epoxy-18,19-dihydro-3-hydroxy-6-methoxy-α-methyl-6,14-ethenomorphinan-7-methanol hydrochloride. It is a white to off-white crystalline powder that is sparingly soluble in water. It is a semisynthetic opioid derived from thebaine.

Naloxone hydrochloride dihydrate is chemically described as 17-allyl-4,5α-epoxy-3,14-dihydroxymorphinan-6-one hydrochloride dihydrate. It is a white to slightly off-white powder that is soluble in water. Naloxone is a semisynthetic opioid antagonist.

The two ingredients are combined in a fixed 4:1 ratio of buprenorphine to naloxone.

Medication Classification

Suboxone is a combination opioid medication used to treat opioid dependence.

• Buprenorphine is a partial opioid agonist. It binds tightly to opioid receptors in the brain but activates them only partially. This reduces cravings and withdrawal symptoms while producing a "ceiling effect," meaning its opioid effects level off at higher doses. This ceiling helps lower the risk of misuse and respiratory depression compared with full opioid agonists.
• Naloxone is an opioid antagonist. When the film or tablet is taken as directed (dissolved under the tongue or in the cheek), very little naloxone reaches the bloodstream. Naloxone is included to discourage misuse. If the product is dissolved and injected, the naloxone can trigger withdrawal symptoms in people who are dependent on opioids.

Suboxone is a Schedule III (CIII) controlled substance under U.S. federal law.

Indication

Suboxone is indicated for the treatment of opioid use disorder (OUD). It should be used as part of a complete treatment program that includes counseling and psychosocial support.

Suboxone is generally used for maintenance treatment. Products containing only buprenorphine are often preferred for the induction (starting) phase, though treatment approaches vary based on your provider's judgment.

Dosage Forms and Available Strengths

• Dosage Forms:
• • Sublingual film (for placement under the tongue or against the inside of the cheek)
  • Sublingual tablets
• Route of Administration: Sublingual (under the tongue) or buccal (inside the cheek), depending on the product
• Available Strengths (buprenorphine / naloxone per unit):
• • Sublingual film: 2 mg / 0.5 mg, 4 mg / 1 mg, 8 mg / 2 mg, and 12 mg / 3 mg
  • Sublingual tablets: 2 mg / 0.5 mg and 8 mg / 2 mg

Formulations and strengths may vary by manufacturer. Confirm the exact product and strength on your label.

Inactive Ingredients

Inactive ingredients vary by dosage form and manufacturer. The sublingual film may contain polyethylene oxide, hydroxypropyl methylcellulose, maltitol, acesulfame potassium, lime flavor, citric acid, sodium citrate, and colorants such as FD&C Yellow No. 6. Sublingual tablets may contain lactose monohydrate, mannitol, corn starch, povidone, citric acid, sodium citrate, magnesium stearate, acesulfame potassium, and flavoring. Refer to the specific product packaging or your pharmacist for exact ingredient details, especially if you have allergies or intolerances.

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Dosage & Administration

Important: Take Suboxone exactly as prescribed by your healthcare provider. Your provider will set your dose based on your condition, your response, and your treatment plan. Do not change your dose on your own.

How to Take Suboxone

Sublingual film:

• Drink water to moisten your mouth before placing the film. This helps it stick and dissolve.
• Place the film under your tongue, close to the base on the left or right side. If more than one film is needed, place them so they do not overlap. Your provider may direct you to place a film against the inside of your cheek instead.
• Keep the film in place until it fully dissolves. Do not chew, swallow, or move the film after placing it, as this can reduce how well it works.
• Do not eat, drink, or talk while the film is dissolving.

Sublingual tablets:

• Place the tablet under your tongue and let it dissolve completely.
• If you need more than one tablet, you may place them all under your tongue at once or in two portions. Keep them under the tongue until fully dissolved.
• Do not chew or swallow the tablets whole, as this makes the medicine much less effective.
• Do not eat, drink, or talk while the tablet is dissolving.

Induction (Starting Treatment)

• The first dose should be taken only when you are showing signs of mild-to-moderate opioid withdrawal, and generally not less than a set number of hours after your last opioid use, as directed by your provider.
• Starting Suboxone too soon, before enough withdrawal has begun, can cause precipitated withdrawal, where withdrawal symptoms come on suddenly and severely.
• Your provider will guide the exact timing based on the type of opioid you were using (short-acting or long-acting).

Maintenance Dosing

• After induction, your provider will adjust your dose to a level that controls cravings and withdrawal without excessive side effects.
• Suboxone is usually taken once daily.
• Use the lowest dose that keeps you stable in your recovery.

Food Considerations

Do not eat or drink until the film or tablet has fully dissolved. Food and drink do not otherwise change how the medicine works, but avoid anything in your mouth during dissolution. Avoid alcohol entirely while taking Suboxone, as the combination can cause dangerous drowsiness and slowed breathing.

Missed Dose Instructions

• If you miss a dose, take it as soon as you remember on the same day.
• If it is almost time for your next dose, skip the missed dose and continue your regular schedule.
• Do not take two doses at once to make up for a missed dose.
• If you miss several doses, contact your provider, as you may be at higher risk of withdrawal or of losing your tolerance.

Storage

• Store at 20° to 25°C (68° to 77°F), with brief excursions permitted between 15° to 30°C (59° to 86°F).
• Keep the film or tablets in their original sealed packaging until you are ready to use them.
• Keep in a dry place, away from moisture, heat, and light.
• Keep out of the reach of children. Accidental use by a child can cause fatal breathing problems.

Disposal

Because Suboxone is a controlled substance, store and dispose of it carefully to prevent theft, misuse, or accidental exposure. Dispose of unused or expired medication through a drug take-back program when possible. If no take-back program is available, the FDA recommends flushing certain buprenorphine-containing products down the toilet to prevent accidental exposure, especially to children. Follow the disposal instructions on your product label or ask your pharmacist. Accidental exposure, especially in children, can cause serious harm or death.

Special Instructions

Children: Suboxone is not for use in children. Accidental exposure to even one dose can cause fatal respiratory depression in a child. If a child is exposed to or swallows this medication, seek emergency care immediately and consider giving naloxone if available.

Elderly or Debilitated Patients: Older patients may be more sensitive to the effects of Suboxone, including drowsiness, dizziness, confusion, and breathing problems. A provider may start at a lower dose and monitor closely, given the higher risk of falls and possible reduced liver, kidney, or lung function.

Patients with Liver Problems: Use with caution. Buprenorphine and naloxone levels can rise in patients with moderate or severe liver problems. Suboxone is not recommended for starting treatment in patients with severe liver impairment. Your provider may choose a different product or adjust your dose and monitor liver function.

Caregivers: Give the medication exactly as prescribed. Watch for excessive sleepiness, slowed or shallow breathing, confusion, or trouble waking the patient, and seek emergency care right away if these occur. Keep the medication secured and out of sight.

Tapering and Discontinuation

• Do not stop taking Suboxone suddenly. Stopping can cause opioid withdrawal symptoms.
• Any decision to stop treatment should involve a gradual, supervised dose reduction planned by your provider.
• Withdrawal symptoms may include restlessness, watery eyes, runny nose, yawning, sweating, chills, muscle aches, widened pupils, irritability, anxiety, backache, joint pain, stomach cramps, trouble sleeping, nausea, vomiting, and diarrhea.
• The length of treatment varies. Many people benefit from long-term maintenance. Do not rush to stop, as leaving treatment early raises the risk of relapse and overdose.

Overdose Warning

An overdose of Suboxone can be serious and may be fatal, especially when combined with benzodiazepines, alcohol, or other CNS depressants. Symptoms of overdose may include:

• Slowed, shallow, or stopped breathing
• Extreme drowsiness or difficulty staying awake
• Loss of consciousness or coma
• Pinpoint pupils
• Cold, clammy skin
• Slow heartbeat or low blood pressure
• Trouble thinking, talking, or walking

In case of a suspected overdose, call the Poison Control Center at 1-800-222-1222 or seek emergency medical care immediately. Naloxone may be used to reverse an opioid overdose. Because buprenorphine binds tightly to opioid receptors and acts for a long time, higher-than-usual or repeated doses of naloxone may be needed, and the person should be watched closely for an extended period, even after the first dose.

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Side Effects

Serious Side Effects Requiring Immediate Medical Attention

Stop taking Suboxone and seek emergency care or contact your healthcare provider right away if you experience any of the following:

• Respiratory depression: Slow, shallow, or stopped breathing; extreme sleepiness; or difficulty waking. This risk is highest when combined with benzodiazepines, alcohol, or other CNS depressants.
• Liver problems (hepatotoxicity): Yellowing of the skin or eyes (jaundice), dark urine, light-colored stools, upper stomach pain, loss of appetite, nausea, or unusual tiredness.
• Severe allergic reactions, including anaphylaxis: Rash, hives, swelling of the face, lips, tongue, or throat, wheezing, or trouble breathing or swallowing.
• Adrenal insufficiency: Ongoing nausea, vomiting, loss of appetite, dizziness, or severe weakness.
• Precipitated withdrawal: Sudden, severe withdrawal symptoms such as anxiety, sweating, shaking, nausea, vomiting, diarrhea, muscle aches, and a fast heartbeat, especially if the first dose is taken too soon.
• Severe low blood pressure: Dizziness, lightheadedness, or fainting, especially when standing up.
• Oral problems: Tooth decay, cavities, oral infections, or loss of teeth have been reported with buprenorphine medicines that dissolve in the mouth. Tell your provider about mouth pain, swelling, or tooth problems.

Common Side Effects

The following side effects may occur and are not always cause for urgent concern. Talk to your healthcare provider if they persist or become bothersome:

• Headache
• Nausea or vomiting
• Constipation
• Sweating
• Trouble sleeping (insomnia)
• Pain, including back pain
• Numbness or reduced feeling in the mouth (oral hypoesthesia)
• Redness or pain in the mouth or tongue
• Dizziness

This is not a complete list of possible side effects. Contact your healthcare provider for guidance about any symptoms that concern you.

To report suspected adverse reactions, contact the FDA at 1-800-FDA-1088

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Warnings & Precautions

FDA Boxed Warning: Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants; and Neonatal Opioid Withdrawal Syndrome

• Risks from concomitant use with benzodiazepines or other CNS depressants: Combining Suboxone with benzodiazepines, alcohol, or other CNS depressants may result in profound sedation, respiratory depression, coma, and death. However, because opioid use disorder can itself be life-threatening, treatment should not be withheld from patients who also take these substances. Instead, providers should manage the combination carefully, adjust doses, and monitor closely.
• Neonatal opioid withdrawal syndrome (NOWS): Prolonged use during pregnancy can result in NOWS in the newborn, which may be life-threatening if not recognized and treated. Newborns should be monitored for signs of withdrawal.

Conditions to Disclose to Your Healthcare Provider

Before taking Suboxone, tell your healthcare provider if you have or have had any of the following:

• Breathing problems, such as asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea
• Liver problems or hepatitis
• Kidney problems
• A head injury, brain tumor, or a condition causing increased pressure in the brain
• Adrenal gland problems, such as Addison's disease
• Low blood pressure or fainting spells
• Gallbladder problems
• Enlarged prostate or urination problems
• Curvature of the spine that affects breathing
• Mental health conditions, including depression
• Alcohol use or a history of substance use
• Dental or mouth problems
• Pregnancy or plans to become pregnant
• Breastfeeding or plans to breastfeed

Contraindications

Do not take Suboxone if you:

• Have a known hypersensitivity to buprenorphine or naloxone. Serious allergic reactions, including anaphylaxis, have been reported.

Drug Interactions

Tell your healthcare provider and pharmacist about all medications, supplements, and herbal products you take. Because buprenorphine is processed mainly by the CYP3A4 liver enzyme, many drugs can affect its levels. Key interactions include:

• Benzodiazepines and other CNS depressants: Combined use increases the risk of profound sedation, respiratory depression, coma, and death. This includes sedatives, tranquilizers, muscle relaxants, sleep medications, and other opioids.
• Alcohol: Drinking alcohol or taking products that contain alcohol adds to the sedative effect and increases the risk of overdose. Avoid alcohol entirely.
• Other opioids: Taking full opioid agonists with Suboxone may reduce their pain-relieving effect or, in some cases, trigger withdrawal. Buprenorphine may also block the effect of other opioids.
• CYP3A4 inhibitors: Drugs such as certain antifungals (for example, ketoconazole, itraconazole), macrolide antibiotics (for example, erythromycin, clarithromycin), and some HIV medications may increase buprenorphine levels and the risk of side effects.
• CYP3A4 inducers: Drugs such as rifampin, carbamazepine, and phenytoin may reduce buprenorphine levels and its effectiveness, and may require dose adjustment.
• Serotonergic drugs: Combined use with certain antidepressants (such as SSRIs, SNRIs, and tricyclics), MAO inhibitors, or other serotonergic medicines may increase the risk of serotonin syndrome.
• Monoamine oxidase inhibitors (MAOIs): May increase the effects of opioids. Use within 14 days of an MAOI is not recommended.
• Anticholinergic drugs: May increase the risk of severe constipation or urinary retention.

Monitoring Requirements

Your healthcare provider may monitor:

• Signs of respiratory depression and sedation, especially with other CNS depressants
• Liver function through blood tests, before and during treatment
• Your response to treatment, including cravings and withdrawal control
• Your risk for misuse, diversion, and continued substance use
• Your dental and oral health
• Signs of adrenal problems with long-term use
• Signs of withdrawal, especially during induction and dose changes

Abuse, Dependence, and Misuse Warnings

Suboxone is a Schedule III controlled substance.

• Although buprenorphine has a lower abuse potential than full opioid agonists, it can still be misused, abused, and diverted.
• The naloxone component is included to discourage misuse by injection. Dissolving and injecting the product can trigger severe withdrawal in people dependent on opioids.
• Physical dependence is expected with continued use. This is not the same as addiction, but it means you should not stop suddenly.
• Do not change your dose on your own.
• Do not sell or give away Suboxone. Doing so may harm others and is against the law. Accidental exposure, especially in a child or a person who is not opioid-tolerant, can be fatal.

Long-Term Use Considerations

• Suboxone is often used as long-term maintenance therapy for opioid use disorder. Staying in treatment is linked to lower rates of relapse and overdose.
• Physical dependence is expected. Any decision to stop should involve a gradual, supervised taper.
• Long-term opioid use may affect hormone levels, leading to symptoms such as low energy, reduced sex drive, or menstrual changes. Tell your provider if these occur.
• Ongoing dental and oral health checks are recommended, given the risk of tooth and mouth problems with medicines that dissolve in the mouth.

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Patient Counseling Information

Safe Medication Use

• Take Suboxone exactly as prescribed. Do not take more than directed or use it more often than prescribed.
• Place the film or tablet under your tongue, or against your cheek if directed, and let it fully dissolve. Do not chew, swallow, cut, or move it once placed, as this reduces how well it works.
• Never dissolve and inject Suboxone. Injecting it can cause severe, sudden withdrawal because of the naloxone component.
• Do not stop taking Suboxone suddenly. Talk to your healthcare provider about a safe plan if you want to stop.
• Do not share Suboxone with anyone else. Sharing is dangerous and against the law.
• Keep Suboxone sealed and stored in a safe, secure place, away from children and others, to prevent accidental exposure, misuse, or theft.
• Read the FDA-approved Medication Guide provided with your prescription.

Risk Prevention

• Benzodiazepines, alcohol, and CNS depressants: Do not use these with Suboxone unless directed by your provider. The combination can cause severe drowsiness, breathing problems, coma, and death.
• Alcohol: Do not drink alcohol while taking Suboxone. Combining them can be dangerous.
• Driving and machinery: Suboxone can make you sleepy or dizzy and can slow your thinking and reaction time, especially when starting treatment or after a dose change. Do not drive or operate heavy machinery until you know how it affects you.
• Naloxone preparedness: Ask your provider about naloxone, a medicine that can reverse an opioid overdose. Make sure family members or caregivers know how to recognize an overdose and use naloxone. Because buprenorphine is long-acting and binds tightly, more than one dose of naloxone may be needed.
• Pregnancy: Tell your provider right away if you are pregnant or plan to become pregnant. Prolonged use during pregnancy can cause neonatal opioid withdrawal syndrome. Your provider will help you decide on the safest treatment plan.
• Breastfeeding: Buprenorphine passes into breast milk. Talk to your provider about the benefits and risks of breastfeeding while taking Suboxone.
• Dental hygiene: After the film or tablet dissolves, gently rinse your mouth with water, swallow, and wait at least one hour before brushing your teeth. Tell your dentist you take Suboxone, and keep up with regular dental checkups to lower the risk of tooth and mouth problems.
• All medicines: Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Do not start or stop other medicines without talking to your provider first.

When to Contact a Healthcare Provider

Contact your healthcare provider or seek emergency care right away if you:

• Have slow, shallow, or stopped breathing, or extreme sleepiness you cannot fight off
• Cannot be easily woken up
• Develop signs of liver problems, such as yellowing skin or eyes, dark urine, or ongoing stomach pain
• Have a severe allergic reaction, such as swelling of the face or throat, hives, wheezing, or trouble breathing
• Develop signs of adrenal problems, such as ongoing nausea, vomiting, loss of appetite, or severe weakness
• Feel faint, very dizzy, or lightheaded
• Have sudden, severe withdrawal symptoms after a dose
• Notice mouth pain, swelling, bleeding gums, or tooth problems
• Experience withdrawal symptoms after reducing or missing doses
• Have any symptom that concerns you or does not go away