Buprenorphine is one of three drugs the FDA has approved to treat opioid use disorder. The other two are methadone and naltrexone [1]. It is itself an opioid. That is not a flaw in the treatment; it is how the treatment works. The FDA’s label calls it a partial opioid agonist. Suboxone pairs it with naloxone, an opioid antagonist [2].
This page is for someone deciding whether to start it. It is also for someone already taking it who wants to know what it is doing, and for a relative who wants to know whether it just swaps one opioid for another. It covers what the drug does at the receptor, which products carry it, who it is prescribed for, why starting it has to wait for withdrawal, who can prescribe it since the federal rule changed in 2023, its side effects, and what stopping it involves. What it does not carry is an amount, a schedule or a switching interval. Those belong to a prescriber. Our overview of medication-assisted treatment covers the wider family of drugs.
The FDA’s prescribing information for Suboxone film opens with two definitions. Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Naloxone is a potent antagonist at mu-opioid receptors. When injected, naloxone brings on withdrawal in people who are physically dependent on full opioid agonists [2].
SAMHSA explains what “partial” means for a person. A full agonist such as methadone binds to the mu-opioid receptor and acts like the body’s own opioid, beta-endorphin. Give more, and the effect grows [3]. A partial agonist binds to the same receptor. But once it has reached its maximal effect in an opioid-tolerant person, giving more may not add any effect [3]. That is the ceiling effect. The FDA’s label says the same thing. Comparisons with full agonists such as methadone and hydromorphone suggest that sublingual buprenorphine produces typical opioid agonist effects which are limited by a ceiling effect [2].
The ceiling is why this drug is trusted with the thing that kills people. SAMHSA states that buprenorphine has less potential to cause respiratory depression, given its ceiling effect. As a partial agonist, its maximum effect on respiratory depression is more limited than a full agonist’s [4]. It also holds the receptor unusually tightly. SAMHSA describes a particularly high receptor affinity. That affinity prevents opioids with lower affinity, such as heroin, from binding, so the net result is a blunting or blocking of their euphoria, respiratory depression and other effects [4].
A ceiling is not immunity. The FDA’s label states that life-threatening respiratory depression and death have occurred with this drug. Many of the reports of coma and death, though not all, involved injecting it or mixing it with benzodiazepines or other depressants, including alcohol [2].
If someone is having a seizure, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.
Two more facts sit side by side here, and they do not contradict each other. Buprenorphine is a Schedule III controlled substance [2]. And NIDA answers the worry about “just another opioid” directly. Methadone and buprenorphine act on the same mu-opioid receptors as other opioid drugs, so some people think they simply substitute one drug for another [5]. But when taken as prescribed by people with opioid use disorder, NIDA says, they prevent cravings and withdrawal without the intense pleasure other opioids produce. That makes them less addictive [5]. In the same passage NIDA adds that, like many drugs, they do produce dependence. Stopping abruptly may bring withdrawal, milder than withdrawal from other opioids [5].
The FDA keeps a current list of the drugs it has approved for opioid use disorder. The buprenorphine entries are: Brixadi, an extended-release injection given under the skin; Sublocade, another extended-release injection given under the skin; Suboxone, a buprenorphine and naloxone film for use under the tongue or against the cheek; Zubsolv, buprenorphine and naloxone tablets for use under the tongue; generic buprenorphine and naloxone tablets and film; and generic buprenorphine tablets for use under the tongue [1].
The label explains why naloxone is in most of them. Because it contains naloxone, Suboxone is likely to cause withdrawal if it is injected by someone dependent on a full agonist such as heroin, morphine or methadone [2]. MedlinePlus puts it in one line: do not inject the film or tablets, because severe reactions may happen, including withdrawal [6]. The naloxone is a deterrent to injecting the product. It is not a second treatment.
Brand names are the confusing part. MedlinePlus lists Subutex as the single-ingredient brand and Bunavail, Suboxone and Zubsolv as the combination brands. It marks three of the four, Subutex, Bunavail and Suboxone, with a note that the branded product is no longer on the market and generic alternatives may be available [6]. The FDA’s current list still names Suboxone film and Zubsolv tablets alongside the generics [1]. The point for a reader is the same either way. What a pharmacy hands over may be a generic. MedlinePlus’s instruction is to check each time that you received the product that was prescribed, and to ask the pharmacist if you are not sure [6].
Buprenorphine is also sold for pain, in forms this page is not about. The FDA notes that pain products deliver it by other routes, such as a skin patch and injection [7]. The Suboxone label points the other way. It records deaths of opioid-naive people who were given buprenorphine as a sublingual tablet for pain relief, and it states that Suboxone is not appropriate as an analgesic [2]. If yours was prescribed for pain, the prescriber who wrote it is the person to ask. Our page on how long Suboxone stays in your system covers testing, which this page does not.
The label’s indication is one sentence. Suboxone film is indicated for the treatment of opioid dependence, as part of a complete treatment plan that includes counseling and psychosocial support [2]. MedlinePlus gives the plain version. Buprenorphine, alone or with naloxone, treats opioid dependence, meaning addiction to opioid drugs including heroin and narcotic painkillers. It works to prevent withdrawal when someone stops taking opioids, by producing effects similar to those drugs [6].
SAMHSA frames who should be considered for it. Its key messages say that pharmacotherapy should be considered for all patients with opioid use disorder. The opioid medications, buprenorphine among them, are reserved for people with moderate-to-severe opioid use disorder who are physically dependent [3]. Whether that describes you is an assessment question. A clinician who has examined you answers it, not a page.
Where that assessment happens has widened. SAMHSA describes the settings as having expanded from specialty sites, meaning certified opioid treatment programs, residential facilities, outpatient addiction programs and addiction specialists’ offices, to primary care practices, health centers, emergency departments, hospital medical and psychiatric units, jails and prisons, and other settings. It states that these drugs should be available across all settings and at all levels of care [8]. NIDA adds that buprenorphine treatment can be started in the emergency department, to ease withdrawal and cravings after an overdose [5]. Our guide to opioid addiction treatment covers the rest of an opioid program. Our page on opioid replacement therapy explains the older name for this approach.
Two groups get a sentence each. On pregnancy: NIDA states that these drugs are safe and effective during pregnancy and breastfeeding [5]. The label describes neonatal opioid withdrawal syndrome as an expected and treatable outcome of prolonged opioid use in pregnancy [2]. MedlinePlus says to call the prescriber if you become pregnant while taking it, and to tell the baby’s doctor right away about irritability, seizures, shaking, vomiting, diarrhea or failure to gain weight in a newborn [6]. On pain: NIDA says both methadone and buprenorphine can reduce pain. People with acute or chronic pain may be advised to keep taking their medication, while some opioid painkillers may work less well alongside it [5]. That is a conversation with the prescriber, not a decision to make alone.
If someone is having a seizure, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.
SAMHSA defines induction as the process of initial dosing until the patient reaches a state of stability, and notes it is also called initiation [3]. The most important thing about it is a timing rule, and the rule runs the opposite way from what people expect. You have to be in withdrawal before the first amount is given.
The FDA’s label states it as an instruction to the prescriber. To avoid precipitating withdrawal, induction should be undertaken when objective and clear signs of withdrawal are evident [2]. SAMHSA explains why. Buprenorphine has weaker agonist effects and stronger receptor affinity than full agonists such as heroin and methadone. It can displace those drugs from the receptors, and that sets off withdrawal all at once. SAMHSA calls this precipitated withdrawal [4]. The label says the same about timing: because of its partial agonist properties, Suboxone may precipitate withdrawal if it is given before the effects of the other opioid have subsided [2].
SAMHSA names what changes the odds, and none of it is a number a reader can act on. The higher a person’s current physical dependence, the higher the chance of precipitated withdrawal. Making sure the person is already in withdrawal when the drug is started lowers that risk. And the longer the time since the last full-agonist opioid, the lower the likelihood [4]. The label adds that people dependent on methadone or other long-acting opioids may be more susceptible to precipitated and prolonged withdrawal during induction than people on short-acting opioids [2]. Our page on methadone covers that drug on its own terms.
What this page does not print is the part that turns those principles into a protocol. The sources it cites publish the hours a prescriber waits after a last opioid, the withdrawal-scale score that signals it is time, the first-day amount and the interval before the next. None of that is here. A person reading it alone at three in the morning is exactly the person it would harm. What is here is how the decision gets made. SAMHSA says the withdrawal has to be visible to the prescriber. For a start at home, it has to meet self-assessment criteria the prescriber set in advance. A scored tool such as the Clinical Opioid Withdrawal Scale can be used to measure it [4]. The label says treatment should begin with supervised administration and move to unsupervised administration as the person’s stability permits [2]. MedlinePlus describes the first amount being taken in the prescriber’s office [6]. The label also lists what the first days most often feel like. The most common adverse event during induction and the three days after it was restlessness. Anxiety, gooseflesh, stomach discomfort, irritability, headache, a runny nose, cold sweat, joint pain and watering eyes were also reported [2]. Our page on medical detox describes the setting where many people are first assessed for this.
One warning belongs with starting the drug, because it is about the household. The label states that buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it. It says to store the drug out of the sight and reach of children and to destroy any unused medication appropriately [2].
If a child has taken it, or if anyone is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.
Opioid use disorder treatment in Washington
The Recovery Village Ridgefield is our campus in Ridgefield, Washington, and its own page cards medical detox, inpatient treatment, partial hospitalization programming, intensive outpatient programming, dual diagnosis treatment and medically-assisted treatment. Its medication card says that for severe opioid or alcohol use disorders, approved medications may be beneficial when medically appropriate, and whether that applies to somebody already prescribed buprenorphine elsewhere is a question the admissions call is for.
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The Recovery Village Ridgefield is part of our family of treatment centers. See the Recovery Village Ridgefield campus.
This is where the law changed. For years a practitioner had to hold a federal waiver, the DATA 2000 waiver, before prescribing buprenorphine for opioid use disorder [9]. That requirement is gone.
SAMHSA’s own statement is this. Section 1262 of the Consolidated Appropriations Act, 2023 removed the federal requirement for a practitioner to file a notice of intent, that is, to hold a waiver, before prescribing drugs such as buprenorphine for opioid use disorder. It also removed the other federal requirements that came with the waiver: discipline restrictions, patient limits, and certification about providing counseling [9]. The rule that replaced it is one sentence. All practitioners who have a current DEA registration that includes Schedule III authority may now prescribe buprenorphine for opioid use disorder in their practice, if permitted by state law [9]. Asked whether there is any limit on the number of patients a practitioner may treat, SAMHSA’s answer is no. There are no longer any patient caps [9].
Two qualifications travel with that, and SAMHSA states both. The Act does not override state law. A state’s own requirements may differ from the federal ones, and a practitioner has to follow them [9]. And a training requirement replaced the waiver, though it is a different kind of requirement. Section 1263 of the same Act applies to practitioners newly applying for or renewing a DEA registration from June 27, 2023. They need one of three things: eight hours of training on opioid or other substance use disorders; board certification in addiction medicine or addiction psychiatry; or graduation within five years from a medical, advanced practice nursing or physician assistant program that included at least eight hours on substance use disorders [9]. That is a condition of holding a registration to prescribe controlled drugs at all. It is not a special buprenorphine license.
Three agencies say what that means for where you can get it. The CDC says buprenorphine can be prescribed by a clinician for use outside of a clinic, while methadone can only be used in a certified opioid treatment program setting [10]. NIDA says that, unlike methadone, buprenorphine can be prescribed by many doctors, nurse practitioners and physician assistants, with no need to visit a special treatment clinic. Since the COVID-19 pandemic, providers can also prescribe it via telehealth [5]. SAMHSA confirms that buprenorphine, as a Schedule III drug, can be prescribed by telehealth so long as the prescription follows all relevant federal, state and local law [9]. SAMHSA also answers the methadone question in one word. The 2023 provisions do not affect treatment with methadone [9]. Our page on opioid treatment programs explains the certified-program system that methadone still runs through.
Access on paper is not access at the counter. NIDA notes that some people have a hard time filling buprenorphine prescriptions, because many pharmacies do not carry or dispense it. It also reports that less than 20 percent of people with opioid use disorder receive any of these drugs [5]. If a pharmacy cannot fill it, tell the prescriber the same day rather than waiting for the next visit.
One more question people ask before they call anyone: does the prescription go on a record an employer could see? The answer is scoped, and the scope is in the regulation. The federal confidentiality rule at 42 CFR Part 2 restricts use and disclosure of records that would identify a patient as having a substance use disorder and that were obtained by a federally assisted substance use disorder program, which the rule calls a part 2 program [11]. Its coverage includes treatment programs, programs within general hospitals, and private practitioners who hold themselves out as providing, and do provide, substance use disorder diagnosis, treatment or referral [11]. SAMHSA applies that to buprenorphine: many practitioners in general medical settings do not meet the definition, so for them Part 2 generally does not apply, even when they prescribe buprenorphine, while HIPAA protections still apply [9]. So the answer depends on where the prescription is written. The honest question for a prescriber is which rule covers their records.
The label’s most common adverse event with the film is oral hypoesthesia, which is numbness in the mouth. The others it lists are constipation, tongue pain, redness of the lining of the mouth, vomiting, intoxication, disturbance in attention, palpitations, insomnia, withdrawal syndrome, sweating and blurred vision [2]. MedlinePlus’s consumer list overlaps it: headache, stomach pain, constipation, trouble sleeping, mouth numbness or redness, tongue pain, blurred vision and back pain, to be reported if severe or persistent [6]. Its list of symptoms to call about at once includes slowed breathing, extreme tiredness, confusion, slurred speech, hives or swelling of the face and throat, and yellowing of the skin or eyes with dark urine or pain in the upper right abdomen [6].
That last cluster is why the label tells prescribers to watch the liver. Cases of hepatitis have been observed. The label’s instruction is to check liver function tests before starting and during treatment, and to evaluate suspected liver events [2]. Its other warnings include adrenal insufficiency, QT prolongation, a drop in blood pressure on standing, and impaired ability to drive or operate machinery [2]. MedlinePlus’s version of the last one is not to drive or use machinery until you know how the drug affects you, and not to drink alcohol while taking it [6].
The dental warning applies to every buprenorphine product that dissolves in the mouth, and it is worth knowing before treatment starts [7]. In January 2022 the FDA warned that dental problems had been reported with buprenorphine products that dissolve in the mouth: tooth decay, cavities, oral infections and loss of teeth. These can be serious, and they have been reported even in patients with no history of dental issues [7]. The FDA had identified 305 cases, 131 of them classified as serious, since the drug was approved. It required a new warning in the prescribing information and the patient Medication Guide [7]. The same communication says the benefits of these drugs clearly outweigh the risks, particularly for opioid use disorder. It warns that suddenly stopping them could cause withdrawal or a return to opioid misuse that could result in overdose and death [7]. The strategies the FDA lists are simple. After the drug has fully dissolved, take a large sip of water, swish it gently around the teeth and gums, and swallow. Wait at least an hour before brushing. Tell the prescriber about any history of tooth problems. See a dentist soon after starting, tell the dentist about the drug, and keep regular checkups [7]. The label now tells prescribers to refer patients to dental care and encourage regular checkups [2].
The interaction with the highest stakes is with sedatives. The label states that using buprenorphine with benzodiazepines or other central nervous system depressants raises the risk of adverse reactions, including overdose, respiratory depression and death. It names alcohol, non-benzodiazepine sleep drugs, tranquilizers, muscle relaxants, antipsychotics, gabapentin and pregabalin, and other opioids [2]. Then it adds a sentence that matters more than the list. Treatment for opioid use disorder should not be categorically denied to people taking those drugs, because barriers to treatment can pose an even greater risk of illness and death from the disorder alone [2]. The label’s approach is to educate the patient about the risk, plan how the other drug will be managed at the start of treatment, and add monitoring where needed [2]. Coming off a benzodiazepine is its own supervised process. Our page on the benzodiazepine taper explains why it is not done abruptly.
If someone who has taken buprenorphine with a sedative or alcohol cannot be woken, is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.
People ask how long they will be on it. The federal sources answer without a fixed endpoint. SAMHSA states that there is no known duration of therapy with buprenorphine, or with methadone or extended-release naltrexone, after which patients can stop the drug and be certain not to return to illicit opioid use. Those who stay in treatment often abstain longer and show increasing clinical stability. Patients should take buprenorphine for as long as they benefit from it and wish to continue [4]. It tells prescribers not to judge progress or success by the amount of medication a person needs, or by how long treatment is required [4]. SAMHSA’s introduction to these drugs says the same from the other side. Arbitrary time limits on the duration of treatment are inadvisable. The best results occur when a patient receives medication for as long as it provides a benefit, which is what maintenance treatment means [8].
SAMHSA defines maintenance treatment as providing medication to achieve and sustain remission of the signs and symptoms of opioid use disorder, and to support recovery, without a specific endpoint. It notes that this is the usual standard of care for other chronic illnesses [3]. Its comparison is to type 2 diabetes. Some people manage that condition with diet and exercise alone. But it is inadvisable to deny people the medication they need, and it is equally not sound medical practice to deny people with opioid use disorder access to FDA-approved drugs [8].
Stopping, when a person and prescriber decide on it together, is described on the label without a number. The decision to discontinue Suboxone after a period of maintenance should be made as part of a comprehensive treatment plan. Patients should be told of the potential to relapse to illicit drug use after stopping. The amount is reduced gradually, to limit withdrawal [2]. The label explains why the reduction is gradual. Long-term use produces physical dependence of the opioid type, with withdrawal on abrupt discontinuation or too-rapid reduction. The withdrawal syndrome is typically milder than with full agonists and may be delayed in onset [2]. MedlinePlus’s instruction to the person is not to stop without talking to the doctor, because stopping too quickly can cause withdrawal. It lists what that looks like: hot or cold flushes, restlessness, teary eyes, a runny nose, sweating, chills, muscle pain, vomiting and diarrhea [6]. Our page on coming off Suboxone covers what a prescriber weighs before anything changes. Our page on Suboxone withdrawal covers the symptoms and what is known about their course. Neither page publishes a schedule, and nor does this one.
The risk that sits after stopping is the one that matters most. SAMHSA states that patients who complete medically supervised withdrawal are at risk of opioid overdose [8]. The label turns that into an instruction to the prescriber. Because patients being treated for opioid use disorder can relapse, and relapse puts them at risk of overdose, prescribers should strongly consider recommending or prescribing an overdose reversal agent such as naloxone or nalmefene, both when starting treatment and when renewing it. They should also consider it when household members, including children, could be at risk of accidental ingestion or overdose [2]. MedlinePlus tells the person the same thing from their side. Talk to the prescriber about having naloxone readily available. Make sure family members know what an overdose looks like and how naloxone is given. If an overdose happens, have someone give the naloxone, call 911 and stay with you until help arrives [6]. Our page on Narcan and naloxone explains what reversal does and what it does not.
If someone is unresponsive, has trouble breathing or may have overdosed, call 911. For a mental-health crisis call or text 988.
The label’s phrase is that Suboxone should be used as part of a complete treatment plan that includes counseling and psychosocial support [2]. What that requires of a patient has been clarified by SAMHSA since the 2023 change, and both halves need saying. Counseling is strongly recommended as an evidence-based practice. SAMHSA says many studies show it gives people tools to manage their condition, and that pairing it with the drug has been linked to better adherence and lower healthcare use [9]. But it is not a condition of the prescription. SAMHSA states that an inability to provide those services, or a patient’s refusal of them, should not prevent a practitioner from prescribing buprenorphine. It says the drug should not be made contingent on taking part in such services, and that the counseling certification was removed along with the waiver [9]. The CDC’s summary is that the evidence-based approaches are the medications and the medications combined with behavioral therapy. It says the medications are especially effective, and that counseling and psychosocial support may provide additional benefit for some patients [10].
What the drug has been shown to do on its own is measurable. NIDA states that people with opioid use disorder who are treated with methadone or buprenorphine are less likely to die or to have an overdose than those who receive no treatment. They are also less likely to engage in behaviors that put them at risk of HIV or hepatitis C [5]. The CDC states that research has shown these medications to be especially effective in helping people recover, and that a recovery plan that includes one of them increases the chance of success [10].
The drug also travels between levels of care, which is the part a treatment program has to get right. SAMHSA lists the levels a person may move through as outpatient counseling, intensive outpatient treatment, inpatient treatment and long-term therapeutic communities. It states that patients in any of those settings should have access to the FDA-approved medications [8]. Our guide to the levels of care sets out the five treatment levels. Our page on inpatient rehab describes the most structured of them, and our page on outpatient rehab describes the level where office-based buprenorphine treatment sits. SAMHSA says primary care physicians are on the front lines of providing office-based treatment with medication for opioid use disorder [8]. A campus in our family that runs medication-assisted treatment says so on its own page, in its own words, and the Ridgefield campus described above is one that does. Whether a particular campus can continue, start or adjust buprenorphine for a particular person is a clinical question. Admissions answers it on the call, and nothing on this page is a promise either way.
The practical questions settle faster than people expect. Our page on how much rehab costs gives our own published price ranges by level of care. Our guide to insurance coverage covers what a plan decides. Our guide to the admissions process sets out what a program needs before it can give someone a date, and our page on what the rehab process is like walks through a stay from the first call. Our centers page lists our campuses grouped by state, and our treatment center directory has a map you can browse by state.
Buprenorphine is one of three drugs the FDA has approved to treat opioid use disorder, with methadone and naltrexone. The Suboxone label’s indication is the treatment of opioid dependence, as part of a complete plan that includes counseling and psychosocial support. MedlinePlus says it works to prevent withdrawal when someone stops taking opioids, by producing effects similar to those drugs. Other buprenorphine products are sold for pain and are not covered by this page.
Buprenorphine is the drug. Suboxone is one brand that combines it with naloxone, an opioid antagonist. The FDA’s current list of approved products for opioid use disorder includes Suboxone film, Zubsolv tablets, two extended-release injections, and generic buprenorphine with and without naloxone. The naloxone is there because the product is likely to cause withdrawal if injected by someone dependent on a full opioid agonist. It is a deterrent to misuse, not a second treatment.
Buprenorphine binds the opioid receptor more tightly than full agonists such as heroin and methadone, while activating it less. So it can displace those drugs and set off withdrawal all at once, which SAMHSA calls precipitated withdrawal. The label’s rule is that induction should be undertaken when objective and clear signs of withdrawal are evident. The hours, scores and amounts a prescriber uses to decide that are deliberately not on this page.
No, not as a federal condition of the prescription. SAMHSA states that a patient’s refusal of counseling, or a practitioner’s inability to provide it, should not prevent the practitioner from prescribing buprenorphine, and that the 2023 law removed the counseling certification that came with the old waiver. SAMHSA still strongly recommends counseling as an evidence-based practice. The label describes the drug as part of a complete plan that includes it.
MedlinePlus’s instruction is not to stop without talking to your doctor, because stopping too quickly can cause withdrawal: hot or cold flushes, restlessness, teary eyes, sweating, muscle pain, vomiting and diarrhea. The larger risk comes after. SAMHSA states that people who complete supervised withdrawal are at risk of opioid overdose. If someone is unresponsive or has trouble breathing, call 911. For a mental-health crisis call or text 988.
This page is for general information and is not medical advice. Only a licensed clinician who knows your history can tell you what is right for you. If you or someone you know is in immediate danger, call 911. For free, confidential support 24/7, call or text 988.
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