Buprenorphine (Subutex)

FDA Approved 2002

Reviewed by the HeyPsych Medical Review Board

Board-certified psychiatrists and mental health professionals

Published November 20, 2025•Updated December 1, 2025•Reviewed December 1, 2025

Clinical summary for Buprenorphine (Subutex): Subutex is a daily under-the-tongue opioid medicine that helps people with opioid addiction feel stable, cut cravings, and avoid withdrawal. It’s safer than heroin or pain pills but still an opioid, so it can cause dependence and overdose—especially if mixed with alcohol, benzos, or other sedatives. Most people take it as part of a full recovery plan that includes counseling, support, and regular follow-up with a prescriber.

What Subutex Is Used For

This entry focuses on Subutex (buprenorphine sublingual tablets without naloxone).

Primary Indications

Opioid use disorder (OUD): Daily under-the-tongue treatment that stabilizes people who are dependent on heroin, fentanyl, or prescription opioids.Medically supervised withdrawal: Used in hospitals or clinics to ease withdrawal when tapering off short-acting opioids.Transition to long-acting buprenorphine (Brixadi, Sublocade) or to buprenorphine/naloxone (Suboxone) after initial stabilization.

Off-Label Uses

Complex chronic pain in people with a history of OUD (specialist use).Short-term bridge when methadone or long-acting depot buprenorphine is not immediately available.

What People Typically Feel on Subutex

Everyone’s experience is different, but common themes from patients include:

Relief from withdrawal and cravings

"“It stopped the sweats, cramps, and bone pain without making me totally knocked out.”"

How Fast It Works and How Long It Lasts

Subutex is relatively fast-acting for withdrawal relief, but its effects build over several days.

30–60 minutes

Early relief of withdrawal symptoms after a dose.

1–3 hours

Peak effect for most people.

24 hours

Typical duration of craving and withdrawal control from a daily dose.

Long half-life (~37 hours)

Supports once-daily dosing; some people feel stable with split dosing (eg, morning + evening) if they also have pain.

How Well Subutex Works for Opioid Use Disorder

Treatment retention and reduction in illicit opioid use

Substantially better than placebo and similar to methadone at adequate doses.

vs Placebo and no-medication approaches have much lower retention and higher relapse rates.

Randomized clinical trials of sublingual buprenorphine (the same active medication as Subutex) show that people are far more likely to remain in treatment and cut down on heroin or pain pill use than those given placebo. In one study of 12 weeks of Subutex 16 mg/day vs placebo, people on Subutex stayed in treatment longer (median 29 vs 11 days) and were much more likely to still be in care at week 12 (about 30% vs 2%). Urine tests showed significantly less illicit opioid use in the buprenorphine group. Other trials and large real-world studies show that buprenorphine reduces overdose risk, improves survival, and is roughly comparable to methadone in helping people stay engaged in care when doses are high enough and follow-up is good. :contentReference[oaicite:2]{index=2}

Critical Safety Information

Mixing buprenorphine with alcohol, benzodiazepines, or other sedatives can slow or stop breathing and be fatal.

→Do NOT drink alcohol or use benzodiazepines, sleep pills, or other opioids unless your prescriber specifically coordinates this and explains how to use them together safely.
→Keep Subutex in a locked box or other secure place. It has street value and can be harmful or fatal to children and people it’s not prescribed for.
→Never inject crushed tablets—this greatly increases overdose, infection, and blood-clot risks.
→Do not stop Subutex on your own. If you want to come off, talk with your prescriber about a slow taper plan.
→Tell your prescriber about any new medicines, supplements, or big changes in alcohol or cigarette use—they can affect buprenorphine levels.
→If you feel very drowsy, confused, or have slow or noisy breathing, or if someone cannot wake you—this is an emergency. Call 911.

Side Effects

Most people tolerate Subutex well once the dose is stable, but sedation, constipation, and headache are common. Risks go up with other sedating drugs or alcohol.

Common Things People Notice

Sleepiness or feeling slowed down
Headache or light-headedness
Constipation and stomach upset
Sweating, dry mouth
Trouble sleeping or vivid dreams
Mild mood changes or anxiety early in treatment

Common Side Effects

Very common, especially at the start or after dose increases

Sedation / Drowsiness— You may feel tired or ‘heavy’ for the first few days. Avoid driving, using machinery, or making major decisions until you know how you react.

Common with all opioids

Constipation— Drink plenty of water, increase fiber, and consider a stool softener or gentle laxative. Let your prescriber know if you go more than 3 days without a bowel movement.

Common early on

Headache / Nausea— Often improves after the first week or two. If severe or persistent, dose adjustments or timing changes may help.

Common

Sweating and temperature changes— Night sweats or feeling hot/cold can occur, especially early or with dose changes.

⚠️ Serious Side Effects

Severe breathing problems (slow, shallow, or stopped breathing), especially with alcohol, benzos, sleep meds, or other opioids.
Extreme sedation, confusion, or inability to wake up.
Severe liver problems (yellow skin or eyes, dark urine, right-upper-belly pain, nausea/vomiting, feeling very unwell).
Serotonin syndrome when combined with certain antidepressants or migraine drugs (agitation, confusion, sweating, fever, rigid muscles, tremor).
Allergic reactions (swelling of face/lips/tongue, trouble breathing, hives).
Heart rhythm problems in people with significant QT prolongation or on other QT-prolonging drugs.
Precipitated withdrawal if started too soon after a full-agonist opioid, especially with fentanyl or methadone on board (sudden, intense withdrawal within 30–120 minutes). :contentReference[oaicite:7]{index=7}

Important Drug & Substance Interactions

Buprenorphine is processed mainly by CYP3A4 and strongly affects the brain’s opioid system. Many drugs and substances can raise side-effect risk or blunt its effect.

With: Alcohol and other CNS depressants (benzodiazepines, Z-drugs, strong sleep aids, many muscle relaxants, gabapentinoids, some antipsychotics)

Risk: Major: Strongly increased risk of extreme sedation, respiratory depression, coma, and death.

Action: Avoid whenever possible. If they must be combined (eg, seizure disorders, severe anxiety), use the lowest doses, coordinate through one prescriber, and co-prescribe naloxone so family can respond to overdose.

With: Other opioids (full agonists like oxycodone, hydromorphone, methadone, fentanyl)

Risk: Buprenorphine can block or blunt the effects of other opioids and may cause withdrawal if started too soon after them. Very high doses of full agonists may be needed for emergency pain control.

Action: For surgery or major trauma, pain management must be coordinated with anesthesia and the buprenorphine prescriber. Don’t increase your own opioid pain meds at home to ‘break through’ Subutex.

With: Opioid blockers (naltrexone, nalmefene)

Risk: Can abruptly block buprenorphine and trigger severe withdrawal and loss of opioid effect.

Action: Avoid routine combination. Naltrexone generally requires a washout period of 7–14 days after the last buprenorphine dose. :contentReference[oaicite:8]{index=8}

With: Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, some HIV/HCV antivirals such as ritonavir-boosted atazanavir)

Risk: Higher buprenorphine levels → more sedation, dizziness, and breathing risk. Atazanavir exposure may fall while buprenorphine levels rise. :contentReference[oaicite:9]{index=9}

Action: Use together only with close monitoring; lower buprenorphine dose may be needed. For some combinations (eg, atazanavir without a booster), alternatives are preferred.

With: Strong CYP3A4 inducers (rifampin, carbamazepine, phenytoin, phenobarbital, primidone, some herbal products like St. John’s wort)

Risk: Lower buprenorphine levels → withdrawal symptoms and return of cravings.

Action: Avoid if possible. If required, dose increases and close monitoring are needed; some people will do better on a different MOUD.

With: Grapefruit juice

Risk: Moderate increase in buprenorphine levels.

Action: Best to avoid frequent grapefruit products while on a stable dose.

With: Serotonergic antidepressants and migraine medicines (SSRIs, SNRIs, MAOIs, triptans, linezolid, etc.)

Risk: Rarely, serotonin syndrome when combined with certain opioids metabolized by CYP3A4; risk is lower than with some other opioids but not zero. :contentReference[oaicite:10]{index=10}

Action: Most people can use antidepressants safely with buprenorphine, but new agitation, fever, sweating, stiff muscles, or confusion needs urgent medical review.

With: Mixed agonist/antagonist opioids (butorphanol, nalbuphine, pentazocine)

Risk: Can displace buprenorphine and trigger acute withdrawal.

Action: Avoid; use full agonists or non-opioid pain strategies instead.

Stopping Subutex Safely

There is no required time limit for treatment—many people stay on buprenorphine for years. If you and your prescriber decide to stop, the dose needs to be reduced very slowly.

Key Points

Stopping suddenly after months or years can cause significant withdrawal and high relapse risk.
Common taper approach: small dose reductions (eg, 10%–25% of the total dose) every 2–4 weeks, slowing down as the dose gets low.
People with long-term heavy opioid histories often need very gradual tapers over many months; some may decide that long-term maintenance is safer than stopping.
Supportive care (clonidine/lofexidine, anti-nausea meds, sleep support, counseling) helps people tolerate tapers better.
If withdrawal or cravings become intense, the taper may need to pause or partially reverse.

Dosing Information (Subutex Sublingual Tablets)

Adult Dosing

induction short acting opioids: Start when clear withdrawal is present (usually ≥8–12 hours after last heroin or short-acting pill). Initial 2–4 mg under the tongue, then repeat 2–4 mg every 1–2 hours on day 1 as needed up to about 8–16 mg.

induction methadone or high fentanyl: Careful, often slower ‘micro-dosing’ or structured cross-taper is used to avoid precipitated withdrawal; doses may start as low as 0.25–1 mg.

typical maintenance: 8–24 mg once daily; some people need up to 32 mg/day, especially with high-potency synthetic opioid exposure. :contentReference[oaicite:11]{index=11}

max supported: Up to 32 mg/day is commonly reported in guidelines and expert practice, though benefit above 24 mg/day is modest for many.

prn use: As-needed use alone is not recommended for OUD; Subutex works best as a consistent daily maintenance medication.

elderly: Start low and go slow; monitor closely for sedation, confusion, falls, and breathing issues.

Simple Explanation

The goal is to reach a dose where you feel ‘normal’—no withdrawal, minimal cravings, and no strong opioid ‘high.’ That dose is then continued long-term while you work on recovery.

Pregnancy, Breastfeeding, and Other Special Groups

Subutex (buprenorphine alone) is often preferred over buprenorphine/naloxone in pregnancy and is generally compatible with breastfeeding when used as prescribed.

👶Pregnancy

For people with opioid use disorder, staying on buprenorphine during pregnancy is strongly recommended over stopping and risking relapse or withdrawal. Guidelines from ACOG and SAMHSA support buprenorphine as a first-line medication for OUD in pregnancy. Babies may develop neonatal opioid withdrawal syndrome (NOWS), but this is treatable and is generally milder and shorter with buprenorphine than with full agonists like methadone or heroin. :contentReference[oaicite:12]{index=12}

🤱Breastfeeding

Only tiny amounts of buprenorphine and its metabolite get into breast milk. Studies show relative infant doses below 1%–2% of the mother’s weight-adjusted dose and normal growth in exposed infants, including with depot formulations. Most expert groups consider sublingual buprenorphine compatible with breastfeeding as long as the parent is stable in treatment and not using other high-risk substances. Monitor babies for unusual sleepiness, poor feeding, or breathing problems. :contentReference[oaicite:13]{index=13}

👧Children & Adolescents (Under 18)

Subutex is not routinely used in children under 16 outside of specialist settings. Adolescents with OUD may receive buprenorphine under close supervision with psychosocial support.

👴Older Adults (65+)

Older adults are more sensitive to opioid side effects (falls, confusion, breathing issues). Use the lowest effective dose and monitor closely.

🔬Liver Impairment

Because buprenorphine is processed in the liver, moderate and severe liver disease require cautious dosing and frequent lab monitoring; some injectable depot forms are not recommended with significant hepatic impairment.

💧Kidney Impairment

No major dose changes are usually needed in kidney disease, but the metabolite can accumulate with very long-term use; monitor for sedation and adjust if needed.

What Clinicians Usually Monitor

Withdrawal and craving control: Is the dose high enough to prevent symptoms without causing heavy sedation?
Use of other substances: Alcohol, benzos, stimulants, and other opioids (via history, PDMP checks, and sometimes urine drug screening). :contentReference[oaicite:14]{index=14}
Liver function: Baseline and periodic liver tests (AST, ALT, bilirubin), especially in hepatitis or heavy alcohol use.
Breathing and sedation, especially when starting, changing dose, or adding other sedating medications.
Heart rhythm risk if the person has a history of QT prolongation or is on other QT-prolonging drugs.
Hormonal and mood changes: Low sex drive, menstrual changes, fatigue, depressive symptoms.
Pregnancy intentions: Discuss contraception and family planning for people of childbearing potential.
Functional outcomes: Ability to work, parent, attend school, and participate in counseling or recovery activities.

Available Buprenorphine Formulations (Where Subutex Fits)

Subutex / generic buprenorphine sublingual tablets (2 mg, 8 mg): Under-the-tongue tablets without naloxone—used for OUD treatment, especially in pregnancy or when naloxone is not appropriate.
Buprenorphine/naloxone (Suboxone, generics): Films or tablets with naloxone added to reduce injection misuse; clinically similar to Subutex when taken under the tongue.
Extended-release injections (Sublocade, Brixadi weekly/monthly): Monthly or weekly depot shots that slowly release buprenorphine—good for people who struggle with daily dosing. :contentReference[oaicite:15]{index=15}
Subdermal implant (Probuphine): Long-acting implant for people already stable on low-dose buprenorphine; use is now limited.
Transdermal patch (Butrans) and buccal film (Belbuca): Designed and labeled for chronic pain, not OUD.
Short-acting injection (Buprenex): For acute pain in hospital or procedural settings.

How Subutex Works in the Brain

Buprenorphine attaches very tightly to the same opioid receptors that heroin, fentanyl, and pain pills use, but it only partially activates them. That ‘partial’ activation is usually enough to stop withdrawal and cravings without causing the same level of euphoria as full opioids. Because it binds so strongly, it also blocks other opioids from attaching, which helps protect against relapse and overdose if someone uses on top—but this also means starting it too early after other opioids can cause sudden withdrawal.

Place in Treatment

Subutex is one of the main medications for opioid use disorder and is broadly considered first-line, especially when buprenorphine/naloxone isn’t appropriate (eg, pregnancy) or when someone is already stable on the mono-product. It works best as part of a comprehensive plan that includes counseling, harm-reduction tools (like naloxone), social support, and attention to housing, employment, and mental health. For many people, staying on buprenorphine long-term is safer than stopping, because it dramatically reduces overdose risk compared with untreated OUD.

References & Further Reading

TIP 63: Medications for Opioid Use Disorder (SAMHSA)ACOG – Opioid Use and Opioid Use Disorder in Pregnancy CDC 2022 Clinical Practice Guideline for Prescribing Opioids for Pain Lindemalm C et al. – Transfer of Buprenorphine Into Breast Milk Buprenorphine FDA Labeling – Subutex / Buprenorphine SL

Frequently Asked Questions

How is Subutex different from Suboxone?

Both contain buprenorphine, the active medication that reduces cravings and withdrawal. Subutex is buprenorphine alone, while Suboxone adds naloxone to discourage injection misuse. When taken under the tongue as prescribed, they work similarly. Subutex is often used in pregnancy or when someone cannot tolerate naloxone; Suboxone is more commonly used in the general adult population.

When can I start Subutex after using heroin, fentanyl, or pain pills?

You need to be in clear withdrawal first—usually at least 8–12 hours after heroin or short-acting pills, and longer (24+ hours) after methadone or some long-acting opioids. Starting too early can cause ‘precipitated withdrawal,’ which feels like an abrupt, intense crash. For heavy fentanyl or methadone use, many clinicians now use very low ‘micro-doses’ of buprenorphine to ease the transition.

Will I be “clean” if I’m taking Subutex?

Subutex is still an opioid, but using it as prescribed to treat OUD is considered recovery, not “using” in the same way as taking heroin or misusing pain pills. It lowers overdose risk, stabilizes your life, and is strongly supported by medical guidelines. Many recovery programs and courts now recognize medications for opioid use disorder as legitimate, lifesaving treatment.

Can I overdose on Subutex?

Yes. Buprenorphine has a ceiling on its opioid effect, so it’s safer than many full-agonist opioids, but overdose is still possible—especially if taken with alcohol, benzodiazepines, sleep meds, or other sedatives, or if you have lung disease. Your prescriber will often recommend that you and the people around you carry naloxone in case of emergency.

Is Subutex safe during pregnancy and breastfeeding?

For people with opioid use disorder, staying on buprenorphine during pregnancy is usually much safer than stopping and risking relapse. Babies may go through treatable withdrawal after birth, but health outcomes are generally better than with uncontrolled opioid use. Subutex is often preferred over Suboxone in pregnancy. Breastfeeding is usually allowed and can actually help ease newborn withdrawal, as long as you are stable in treatment and not using other unsafe substances.

How long will I need to stay on Subutex?

There is no one-size-fits-all answer. Some people stay on buprenorphine for years; others taper off after they’ve built strong supports and feel stable. Stopping too soon is linked to a higher risk of relapse and overdose. Any decision to taper should be slow and planned with your prescriber, and you should have strong support in place.

What if I miss a dose?

Take it as soon as you remember, unless it’s close to the next dose—then just take your usual next dose. Don’t double up. If you miss several doses in a row, you might start having withdrawal or cravings again. Call your prescriber; you may need a supervised restart, especially if you used other opioids in the meantime.

Will Subutex show up on a drug test?

Yes, specialized tests can detect buprenorphine and its metabolite. Standard opioid panels may or may not pick it up, depending on the lab. If you’re in a program, job, or legal situation where this matters, bring your prescription and be open about your treatment.

This medication information is for educational purposes only and is not a substitute for professional medical advice. Always consult your healthcare provider before starting, stopping, or changing any medication. Never take medication without a prescription from a licensed healthcare provider.

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Buprenorphine (Subutex)

FDA Approved 2002

Reviewed by the HeyPsych Medical Review Board

Board-certified psychiatrists and mental health professionals

Published November 20, 2025•Updated December 1, 2025•Reviewed December 1, 2025