Suboxone contains two active drugs: Buprenorphine, a mixed opioid agonist-antagonist, and naloxone, an opioid antagonist.
Buprenorphine is an effective treatment for opioid dependence that blocks opioid receptors in the brain to prevent withdrawal symptoms. It produces the same effects as other opioid drugs without causing excessive sedation or euphoria.
In comparison, naloxone is present in Suboxone to deter a person from dissolving Suboxone and injecting it intravenously (into a vein). Together, these drugs prevent withdrawal symptoms after a person stops taking opioid drugs, such as heroin or narcotic painkillers.
While Suboxone is a brand-name drug, the combination of buprenorphine and naloxone also exists as a generic product administered in the form of a sublingual film (a medication that is dissolved under the tongue).
Additionally, other orally administered, brand-name drugs containing (buprenorphine and naloxone) also exist, such as Zubsolv, which is given in the form sublingual tablets.
However, this article will highlight Suboxone, available as a sublingual film.
What Is Suboxone Used For?
The Food and Drug Administration (FDA) has approved Suboxone to treat opioid use dependence in individuals who have recently stopped taking an opioid product and wish to lessen the severity of their withdrawal symptoms.
Brand Name(s): Suboxone, Zubsolv
Drug Availability: Prescription
Therapeutic Classification: Opioid dependency
Available Generically: Yes
Controlled Substance: Schedule III
Administration Route: Sublingual
Active Ingredient: Bupronephrine hydrochloride and naloxone hydrochloride
Dosage Form(s): Sublingual film, sublingual tablet
Suboxone should be part of a complete drug abuse treatment program, including compliance and psychosocial support such as counseling, behavioral contract, and lifestyle changes.
The Drug Addiction Treatment Act of 2000 (DATA), codified at 21 U.S.C 823 (g), allows only qualified healthcare providers who have assigned a unique identification number to dispense or prescribe Suboxone to treat opioid dependence. This number should be written on every prescription.
How to Take Suboxone?
Potential and current users should note the following instructions as it relates to the safe consumption of Suboxone:
You should be experiencing moderate to severe symptoms of withdrawal before taking Suboxone.
To use, rinse your mouth thoroughly with water before inserting the film. From there, place the film under your tongue and hold it in place for five seconds. Of note, If you’re using two films, place the other one on the opposite side beneath the tongue.
Never put the films on top of or near each other. What’s more, don’t use more than two films at once, and don’t swallow, chew or move the film while it dissolves. Do not eat or drink anything until the film is completely dissolved.
Wait at least one hour after taking Suboxone before brushing your teeth. Be sure to get regular dental exams and follow your dental healthcare provider’s recommendations for oral health.
If using the sublingual tablets, place them under your tongue until they melt. If you are taking more than two tablets, either place them all under your tongue at the same time or place them under your tongue up to two at a time.
Do not chew the tablets or swallow them whole. Do not eat, drink, or talk until the tablet dissolves completely.
Don’t take this medicine for conditions other than prescribed. Don’t stop taking Suboxone on your own. Your healthcare provider will determine how to stop taking it gradually.
Storage
Keep Suboxone tightly closed and out of the reach of children and pets, ideally locked in a cabinet or closet due to risks associated with accidental intake, abuse and misuse.
Store at room temperature (68 F to 77 F). Do not store your medication in the bathroom.
Immediately discard unwanted or expired medicine. Ask your healthcare provider about the medicine-take-back program in your area.
If you don’t have access to the medicine-take-back program, discard the unwanted film in the toilet. Take all the films out of the packing and flush them down the toilet.
If you travel with Suboxone, get familiar with your final destination’s regulations.
In general, be sure to make a copy of your Suboxone prescription. Keep your medication in its original container from your pharmacy with your name on the label. Ask your healthcare provider if you have any questions about traveling with your medicine.
Off-Label Uses
Suboxone may be used off-label for treating conditions other than those described and listed in its prescribing information packet.
Specifically, Suboxone is thought to be useful in improving major depressive disorder (MDD) and is a drug of choice in pain management.
What Are the Side Effects of Suboxone?
This is not a complete list of side effects, and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
Specifically, Suboxone should achieve its peak effectiveness around an hour and 40 minutes after the first dose. However, a person’s dosage may be increased until the medication can effectively reduce symptoms of withdrawal. Nonetheless, most users feel better at the end of the first day.
Common Side Effects
Common side effects of Suboxone may include but may not be limited to:
Back pain Blurred vision Constipation Dizziness Difficulty falling asleep or staying asleep Drug withdrawal Fainting Feeling lightheaded Headache Irregular heartbeat Mouth numbness or redness Nausea and vomiting Numb mouth Stomach pain Sweating Swollen or painful tongue
Severe Side Effects
Contact your healthcare provider immediately if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.
Severe side effects of Suboxone may include:
Allergic reactions (hives, rash/itching, difficulty breathing or swallowing, swelling of the face, lips, eyes, throat, tongue, hands, feet, ankles, or lower legs) Decreased libido (sexual desire) Erectile dysfunction (inability to get or keep an erection) Dependency or abuse Irregular menstruation Liver problems (pain in the upper right part of the stomach, nausea, loss of appetite, jaundice [yellowing of the skin or eyes], dark-colored urine, light-colored stools) Opioid withdrawal (agitation, goose bumps, runny nose, watery eyes, feeling hot or cold than usual, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea) Respiratory problems (higher risk of coma or death if you take other medicines, such as benzodiazepines) Lethargy Slurred speech Unusual bleeding or bruising
This may not be a complete list of side effects. Call your healthcare provider if you have any new or worsening symptoms.
Long-Term Side Effects
Long-term use of Suboxone may cause drug dependency. However, the long-term use of Suboxone does reduce the effects of withdrawal as a result of quitting other opioids.
Dosage: How Much Suboxone Should I Take?
Suboxone should only be prescribed by a licensed healthcare provider. Your healthcare provider will determine and administer the proper dosage of Suboxone for you.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
Modifications
The following modifications (changes) should be kept in mind when using Suboxone:
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For buccal dosage form (film): For induction treatment of opioid dependence: Adults—On Day 1, your doctor may give you an induction dosage up to 4. 2 milligrams (mg) of buprenorphine and 0. 7 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 8. 4 mg of buprenorphine and 1. 4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone. Children—Use and dose must be determined by your doctor. For maintenance treatment of opioid dependence: Adults—8. 4 milligrams (mg) of buprenorphine and 1. 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. For buccal or sublingual dosage form (film): For induction treatment of opioid dependence: Adults—On Day 1, your doctor may give you an induction dosage up to 8 milligrams (mg) of buprenorphine and 2 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 16 mg of buprenorphine and 4 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting, or long-acting opioid medicines, your doctor may recommend you to take buprenorphine alone. Children—Use and dose must be determined by your doctor. For maintenance treatment of opioid dependence: Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. For sublingual dosage form (tablets): For induction treatment of opioid dependence: Adults—On Day 1, your doctor may give you an induction dosage up to 5. 7 milligrams (mg) of buprenorphine and 1. 4 mg of naloxone in divided doses. On Day 2, your doctor may give you up to 11. 4 mg of buprenorphine and 2. 9 mg of naloxone taken as a single dose. If you have been taking methadone, heroin, short-acting or long-acting opioid medicines, your doctor may recommend you take buprenorphine alone. Children—Use and dose must be determined by your doctor. For maintenance treatment of opioid dependence: Suboxone®: Adults—16 milligrams (mg) of buprenorphine and 4 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. Zubsolv®: Adults—11. 4 milligrams (mg) of buprenorphine and 2. 9 mg of naloxone taken as a single dose once a day. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor.
Severe allergic reaction: Avoid using Suboxone if you have a known allergy to it or its ingredients. Ask your healthcare provider for a complete list of the ingredients if you’re unsure.
Pregnancy: We don’t know enough about the safety and effectiveness of Suboxone in pregnant people and their unborn fetuses. Discuss with your healthcare provider if you plan to become pregnant or are pregnant, and weigh the benefits and risks of taking Suboxone during your pregnancy.
Chronic use of opioids may reduce fertility in people of reproductive potential or child-bearing age.
Breastfeeding: Bupronephrine is released in breast milk. We don’t know enough about the safety of Suboxone in human breast milk and nursing babies. The decision should be made considering the individual’s clinical need and potential adverse effects on the nursing child.
Talk with your healthcare provider if you plan to breastfeed, to weigh the benefits and risks of taking Suboxone while nursing and the different ways to feed your baby.
Adults over 65: Clinical studies haven’t included a large enough number of people in this age group to see whether they respond differently from younger adults.
Older adults with several medical conditions or taking several medications should use caution with Suboxone. Older adults might also be more sensitive to Suboxone’s side effects.
Children: The safety and effectiveness of Suboxone have not been established in adolescents. It is not suitable for use in people under the age of 16.
Other modifications: Suboxone use should be avoided in people with severe liver impairment. It is also inappropriate to use for those with moderate liver issues.
Missed Dose
If you accidentally forgot your Suboxone dose, take it as soon as you remember. If it’s already close to your next scheduled dose, skip the missed dose and take the following dose at your next scheduled dosing time. Don’t try to double up to make up for the missed dose.
Try to find ways that work for you to help yourself remember to keep your appointments and take your medication routinely. If you miss too many doses, Suboxone might be [less] effective at treating your condition.
Overdose: What Happens If I Take Too Much Suboxone?
If you think you’re experiencing an overdose or life-threatening symptoms, seek immediate medical attention.
The symptoms of a suspected overdose of Suboxone include:
Pinpoint pupils (abnormally small pupils under normal lightening conditions) Sedation (unable to respond or wake up) Extreme drowsiness Hypotension (low blood pressure) Respiratory depression The potential for death
Precautions
What Are The Reasons I Shouldn’t Take Suboxone?
If you’re allergic to Suboxone or any of its ingredients, avoid using it. Ask your healthcare provider for a full list of the ingredients if you’re unsure.
If someone collapses or isn’t breathing after taking Suboxone, call 911 immediately.
Do not use this medicine if you have used an MAO inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused films or tablets in a safe and secure place. People who are addicted to drugs might want to steal this medicine.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Using too much of this medicine may cause an overdose, which can be life-threatening. Symptoms of an overdose include: blurred vision, confusion, difficult or trouble breathing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position or sitting position, irregular, fast or slow, or shallow breathing, pale or blue lips, fingernails, or skin, pinpoint pupils, sleepiness, sweating, unusual tiredness or weakness. In case of an overdose, call your doctor right away. Your doctor may also give naloxone to treat an overdose.
This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.
This medicine may cause serious tooth problems. Tell your doctor right away if you have cavities, tooth decay, tooth pain, tooth infection, tooth erosion, tooth fracture, or tooth loss.
Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Serious unwanted effects can occur if certain medicines are given together with buprenorphine and naloxone combination.
This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of the medicines listed above while you are using this medicine.
Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Using this medicine while you are pregnant may cause neonatal opioid withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.
This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, hives, itching, hoarseness, trouble with breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.
Do not suddenly stop using it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility of withdrawal symptoms, including anxiety, fever, nausea, runny nose, stomach cramps, sweating, tremors, or trouble with sleeping.
Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.
Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Suboxone may not be suitable in certain conditions. Tell your healthcare provider if you have any of the following conditions:
Liver or kidney problems Lung problems or trouble breathing Benign prostatic hyperplasia (BPH; an enlarged prostate gland) Head injury or brain problems Problem urinating Have a curve in the spine that affects breathing Gallbladder problems Addison’s disease (a chronic condition where your adrenal glands fail to make enough cortisol and aldosterone) Adrenal gland problems Hypothyroidism (a thyroid gland that creates little to no thyroid hormone) History of alcoholism Mental problems, such as hallucinations Pregnancy Breastfeeding
What Other Medications Interact With Suboxone?
Use caution when taking Suboxone with the following medications:
BInenzodiazepines and the central nervous system (CNS) depressants: Due to additive pharmacological effects, concomitant use of these drugs can lead to respiratory depression, sedation, coma, and even death. Examples of some medicines are:
Alcohol Benzodiazepines, such as Xanax (alprazolam), Tranxene (clorazepate), Valium (diazepam) Muscle relaxants, such as Amrix (cyclobenzaprine), Dantrium (dantrolene), and Skelaxin (metaxalone) General anesthetics Antipsychotics, such as chlorpromazine, Clozaril (clozapine), Haldol (haloperidol), Zyprexa (olanzapine), Risperdal (risperidone), thioridazine and others
Inhibitors of CYP3A: The simultaneous use of these drugs alongside Suboxone can cause an increase in the plasma concentration of Suboxone, resulting in an increased opioid effect. Examples of these drugs include:
Macrolide antibiotics, such as Ery-Tab (erythromycin) Azole antifungals agents, such as ketoconazole Protease inhibitors, such as Norvir (ritonavir)
CYP3A4 Inducers: When used with Suboxone, these drugs can decrease the plasma concentration of buprenorphine, resulting in decreased efficacy or onset of a withdrawal syndrome. These include:
Rifadin (rifampin) Tegretol (carbamazepine) Dilantin (phenytoin)
Antiretrovirals: Non-nucleoside reverse transcriptase inhibitors (NNRTIs): Monitor the dose of Suboxone in people who start taking NNRTIs. Examples include:
Sustiva (efavirenz) Viramune (nevirapine) Intelence (etravirine)
Antiretrovirals: Protease inhibitors (PIs): Monitor the dose of Suboxone when taking atazanavir with and without ritonavir.
Reyataz (atazanavir) Norvir (ritonavir)
Serotonergic drugs: The simultaneous use of opioids with serotonergic drugs (medications that impact levels of serotonin) requires careful observation during treatment initiation and dose adjustments. Discontinue Suboxone if serotonin syndrome is suspected:
Selective serotonin reuptake inhibitors, such as Celexa (citalopram), Lexapro (escitalopram), Prozac (fluoxetine), Luvox (fluvoxamine), Brisdelle (paroxetine) and Zoloft (sertraline) Serotonin and norepinephrine reuptake inhibitors, such as Cymbalta (duloxetine), Pristiq (desvenlafaxine), Savella (milnacipran), and Effexor XR (venlafaxine) Tricyclic antidepressants, such as amitriptyline, Anafranil (clomipramine), Norpramin (desipramine), Silenor (doxepin), Tofranil (imipramine), Pamelor (nortriptyline), Vivactil (protriptyline), and trimipramine Triptans (a class of drugs used to lessen the effects of an ongoing migraine) 5-HT3 receptor antagonists, such as Lotronex (alosetron) or Akynzeo (netupitant and palonosetron) Certain muscle relaxants, such as Amrix (cyclobenzaprine), Dantrium (dantrolene), and Skelaxin (metaxalone)
Monoamine oxidase (MAO) inhibitors: The use of Suboxone is not recommended in people taking MAOIs or within 14 days of stopping the treatment with MAOIs. These include drugs such as:
Nardil (phenelzine) Marplan (isocarboxazid) Methylene blue Zyvox (linezolid)
Anticholinergic drugs: The simultaneous use of Suboxone and anticholinergic medications may lead to urinary retention or severe constipation. If used, monitor the signs of these problems.
Diuretics: The efficiency of diuretics may be reduced.
This may not be a complete list of drugs that interact with Suboxone. For more detailed information about medication interactions with Suboxone, talk with your healthcare provider.
And be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC), nonprescription products, vitamins, herbs, or plant-based medicines.
What Medications Are Similar?
In addition to Suboxone, other drugs used to treat opioid dependence include:
Methadone Vivitrol (naltrexone) Sublocade (buprenorphine)
Other brand names containing buprenorphine and naloxone are:
Zubsolv (buprenorphine and naloxone)
Do not take any medicine without consulting your healthcare provider. Never switch between brands of the same drug unless advised to do so by a healthcare provider.
How Can I Stay Healthy While Taking Suboxone?
Take Suboxone as recommended by your healthcare provider.
At proper doses, buprenorphine decreases the pleasurable effects of other opioids, causing a decrease in misuse. Meanwhile, naloxone is present in Suboxone to deter a person from dissolving Suboxone and injecting it intravenously.
Never inject this medicine, as it can cause severe withdrawal effects. Suboxone is part of a treatment plan that includes psychosocial support as well.
Consider support groups or working with a mental healthcare provider to help you find coping strategies to change how you think, feel, react, or respond to living with opioid dependence.
Don’t drive or operate dangerous machinery until you know that it does not adversely affect your mental ability to pay attention or focus. Don’t share your medicine with anyone, even if they have the symptoms of opioid use disorder.
Keep your medicine in a safe place, preferably locked. An accidental intake by a child can lead to respiratory depression and even death. Discard the unused, unwanted, or expired medicine in the toilet and flush it.
If breastfeeding people take Suboxone, closely monitor the signs of excessive sleep or drowsiness in the breastfed child. Don’t stop taking it on your own without the permission of a healthcare provider.
