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Buprenorphine–Naloxone (Suboxone, Zubsolv)

FDA Approved 2002

Reviewed by the HeyPsych Medical Review Board

Board-certified psychiatrists and mental health professionals

Published January 1, 2025•Updated January 1, 2025

Clinical summary for Buprenorphine–Naloxone (Suboxone, Zubsolv): This medicine is used to treat opioid addiction, not regular pain. It helps with cravings and withdrawal so you can focus on recovery. You let a film or tablet melt under your tongue or inside your cheek. Used the right way, it lowers overdose risk and helps people stay off heroin or pain pills, but it can still cause side effects, dependence, and breathing problems—especially if mixed with other sedating drugs or alcohol.

What It's Used For

Buprenorphine–naloxone is a maintenance medication for opioid use disorder (OUD). It is not meant for as-needed pain control. The goal is to stabilize you, cut cravings and withdrawal, and help you stay away from heroin, fentanyl, or prescription pain pills.

Primary Indications

Opioid Use Disorder: heroin, fentanyl, or prescription opioid (eg, oxycodone, hydrocodone, morphine) use with loss of control, cravings, or harmful consequencesTransition from high-risk, street opioid use to a safer, regulated treatmentLong-term relapse prevention once you are stabilized

Off-Label Uses

Occasionally used in specialized settings for pain in people with OUD, but the combo product is primarily designed and labeled for opioid use disorder.

What People Feel

Experiences vary a lot, but people often describe a few common themes:

Relief from withdrawal and cravings

"Within an hour my stomach stopped cramping and the sweats eased up."

How Fast It Works

During induction, timing is crucial—starting too early after your last opioid can actually trigger withdrawal. Once you’re stabilized, each daily dose generally holds you for 24 hours.

Short-acting opioids (heroin, most pain pills)

usually wait ≥12 hours and until clear withdrawal signs appear before the first dose.

Methadone or other long-acting opioids

you may need 24–48+ hours and noticeable withdrawal before starting.

Onset

withdrawal relief typically begins within 30–60 minutes of a dose.

Duration

one properly titrated daily dose usually covers 24 hours of withdrawal and craving control.

Because buprenorphine leaves the body slowly, missing a single dose may not cause immediate severe withdrawal—but repeated missed doses usually will.

How Well It Works

1-Year Retention in Treatment

0
vs 0% on placebo
In a landmark Swedish trial of people with heroin dependence, three-quarters of those who received buprenorphine as part of a relapse-prevention program stayed in treatment for a full year, compared with none of those assigned to placebo. Those who stayed on buprenorphine had dramatically less heroin use and better social functioning.

Critical Safety Information

Critical Safety Information

This is still an opioid. Used correctly it reduces overdose risk, but mixing it with other sedating drugs or taking it in unsafe ways can be deadly.
  • →Never mix this medication with alcohol, benzodiazepines (like Xanax, Ativan), sleep meds, or street sedatives unless your prescriber knows and monitors you closely.
  • →Keep naloxone (Narcan or similar) in your home and show family or friends how to use it in case of overdose.
  • →If you feel very drowsy, have slow or noisy breathing, or others can’t easily wake you up, that is an emergency—seek help immediately.
  • →Do not stop this medication on your own; work with your prescriber on a slow, supervised taper if and when you’re ready.
  • →Store films and tablets safely—just one dose can be life-threatening to a child or opioid-naïve adult.

Side Effects

Most people tolerate buprenorphine–naloxone reasonably well. The most frequent problems are headache, constipation, sweating, stomach discomfort, and sleep changes.

Common Things People Notice

  • Headache
  • Constipation (hard stools, straining)
  • Nausea or stomach upset
  • Sweating more than usual
  • Trouble sleeping or vivid dreams
  • Mouth irritation with films or tablets

Common Side Effects

Common
Headache— Often improves over time; staying hydrated and using simple pain relievers (if safe for you) may help.
Very common with all opioids
Constipation— Plan ahead with fluids, fiber, and possibly a stool softener or laxative. Constipation usually does not improve on its own while you stay on an opioid.
Common
Sweating and feeling warm— Can be bothersome but is usually not dangerous. Let your prescriber know if it becomes severe.
Reported with long-term transmucosal use
Mouth and dental issues— Let the film or tablet fully dissolve, then swish water and swallow. Wait at least an hour before brushing your teeth. Regular dental checks are important.

⚠️ Serious Side Effects

  • Slow or difficult breathing, extreme sleepiness, or unresponsiveness—emergency.
  • Severe allergic reaction (rash, swelling of face or throat, trouble breathing).
  • Severe liver problems (yellow skin or eyes, dark urine, upper-right abdominal pain, severe fatigue).
  • Significant drop in blood pressure causing dizziness or fainting.
  • Significant heart rhythm issues in vulnerable patients (especially if combined with other QT-prolonging drugs).
  • Severe or prolonged precipitated withdrawal during induction.

Critical Drug Interactions

Buprenorphine–naloxone interacts with many other medicines and substances, especially those that slow the brain or affect how the liver processes drugs.

With: Other opioids (heroin, fentanyl, oxycodone, methadone, etc.)

Risk: Taking full-agonist opioids on top of buprenorphine can lead to overdose because very high doses may be needed to “break through” its partial blockade.

Action: Avoid non-prescribed opioid use. If you need surgery or acute pain treatment, your team may adjust your buprenorphine and carefully add short-acting opioids under close monitoring.

With: Benzodiazepines (Xanax, Ativan, Klonopin), sleep medicines, alcohol, other sedatives

Risk: High risk of dangerous breathing problems, coma, and death.

Action: Use only when absolutely necessary and under one prescriber’s supervision. Strongly consider a naloxone rescue kit and educate family or roommates.

With: CYP3A4 inhibitors (some antifungals, certain antibiotics, some HIV medications)

Risk: Can raise buprenorphine levels, increasing sedation and respiratory risk.

Action: Your prescriber may lower your buprenorphine dose and monitor you more closely.

With: CYP3A4 inducers (some seizure medicines, rifampin, St. John’s wort)

Risk: Can lower buprenorphine levels, causing withdrawal or cravings.

Action: Avoid strong inducers when possible or adjust buprenorphine dosing under supervision.

With: Other medications that slow gut movement (eg, strong anticholinergics, some IBS drugs)

Risk: Higher risk of severe constipation or bowel blockage.

Action: Monitor bowel habits carefully and treat constipation aggressively.

With: Long-acting opioid blockers (oral or injectable naltrexone, nalmefene)

Risk: They block buprenorphine’s effect and can trigger severe withdrawal if started too early.

Action: Requires careful planning and washout periods in both directions; never switch on your own.

Stopping or Tapering Safely

There is no time limit on buprenorphine treatment—many people stay on it for years, and staying on it can be far safer than returning to uncontrolled opioid use. If you and your prescriber decide it’s time to taper, going slowly is key.

Key Points

  • Never stop suddenly; expect withdrawal symptoms and high relapse risk if you do.
  • Typical tapers are measured in months, not days: small dose reductions every 1–2+ weeks.
  • People with long-standing OUD or multiple past relapses often do best with ongoing maintenance rather than tapering.
  • Supportive treatments—therapy, peer support, housing and employment resources—make tapering more successful.
  • If withdrawal becomes too strong or cravings surge, the taper can be slowed, paused, or reversed.

Dosing Information (Overview, Not Instructions)

Adult Dosing

induction short acting: Start when clear withdrawal is present (usually ≥12 hours after last short-acting opioid). A common approach is 2–4 mg buprenorphine initially, then repeat small doses every 1–2 hours on day 1 as needed, up to roughly 8–12 mg.

induction long acting: From methadone or other long-acting opioids, taper to a lower dose first, then start buprenorphine only once withdrawal has clearly begun, often 24–48+ hours after the last methadone dose.

maintenance typical: Many adults stabilize between 8–16 mg buprenorphine per day (often given once daily). Some need up to 24 mg/day; higher doses are less well studied.

elderly: Start at the low end of dosing, monitor closely for sedation and breathing problems.

hepatic: Avoid in severe liver impairment; use cautiously and monitor closely in moderate impairment.

renal: No routine adjustment for kidney disease, but monitor overall tolerance in advanced kidney failure.

Simple Explanation

You are usually started at a lower dose during withdrawal and gradually increased over a few days until your cravings and withdrawal are controlled. After that, you stay on a stable daily dose that keeps you feeling steady.

Pregnancy, Breastfeeding, Special Groups

Treatment of opioid use disorder in pregnancy and other special situations is complex and should involve specialists whenever possible.

👶Pregnancy

For people who are pregnant and have OUD, medication treatment with an opioid agonist (methadone or buprenorphine) is generally recommended over withdrawal, because untreated OUD carries high risks for both parent and baby. Buprenorphine alone is usually preferred when starting treatment in pregnancy. If someone becomes pregnant while already stable on buprenorphine–naloxone, many clinicians continue the combo product rather than risking destabilization.

🤱Breastfeeding

Buprenorphine passes into breast milk in low amounts, and breastfeeding is often encouraged in stable patients with OUD who are otherwise appropriate candidates. Infants should be monitored for unusual sleepiness or feeding problems. Decisions about breastfeeding while on buprenorphine–naloxone should be individualized.

👧Children & Adolescents (Under 18)

Use in adolescents is typically limited to specialized programs. Dosing is usually similar to adults but requires close family involvement, psychosocial support, and attention to legal and consent issues.

👴Older Adults (65+)

Older adults may be more sensitive to sedation, breathing changes, and falls. Start low, go slow, and monitor closely.

🔬Liver Impairment

Because both components are metabolized by the liver, moderate and especially severe impairment can raise levels. Avoid in severe liver failure and use cautiously with close monitoring in moderate impairment.

💧Kidney Impairment

Kidney problems do not usually require dose changes, but advanced kidney disease can complicate overall care, so prescribers may be more cautious.

Clinical Monitoring

  • Respiratory status and level of alertness, especially during induction and dose increases.
  • Blood pressure and heart rate, particularly in patients with cardiovascular disease.
  • Liver function tests (ALT, AST, bilirubin) at baseline and periodically in patients with liver risk factors.
  • Signs of misuse, diversion, or unsafe use (early refills, lost prescriptions, non-prescribed sedatives).
  • Ongoing opioid use via history, physical exam, and (when appropriate) urine drug testing.
  • Adherence and functional outcomes: work, school, relationships, legal involvement, housing stability.
  • Dental health over time in patients using transmucosal products chronically.
  • Pregnancy status when relevant, as this may change treatment strategy.

Available Formulations

  • Sublingual films (Suboxone and generics): strips placed under the tongue or inside the cheek (common strengths like 2/0.5 mg, 4/1 mg, 8/2 mg, 12/3 mg).
  • Sublingual tablets (Suboxone, generics, Zubsolv): tablets that dissolve under the tongue, with different strengths and bioavailability profiles.
  • All forms are controlled substances—storage in a safe place is essential to prevent accidental or intentional misuse.

How It Works in the Body

Buprenorphine partially activates the same opioid receptors that drugs like heroin and oxycodone use, but in a controlled way with a ceiling effect. This means it can relieve withdrawal and cravings without producing the same intense high as full opioids. Naloxone is mostly inactive when the medicine is used under the tongue or inside the cheek, but if someone tries to inject the product, naloxone becomes active and blocks opioid effects—this helps deter misuse.

Place in Treatment

Buprenorphine–naloxone is a first-line medication for opioid use disorder and is strongly favored over detox-only approaches. Staying on medication treatment for OUD is associated with lower overdose risk, fewer emergency visits and hospitalizations, and better functioning. Stopping medication too early, or never starting it, is linked with high relapse rates in most studies.

References & Further Reading

Kakko et al. (2003) – 1-year retention and social function with buprenorphineSuboxone (buprenorphine and naloxone) Prescribing InformationASAM National Practice Guideline for the Treatment of Opioid Use DisorderSAMHSA – Medications for Substance Use DisordersFDA – Long-term opioid use and labeling updates

Frequently Asked Questions

What is Suboxone used for?

Suboxone (buprenorphine–naloxone) is used to treat opioid use disorder—dependence on heroin, fentanyl, or prescription pain pills. It is not meant for as-needed pain relief. It helps control cravings and withdrawal so you can focus on recovery, therapy, and rebuilding your life.

Does Suboxone just replace one addiction with another?

No. Suboxone can cause physical dependence, but that’s not the same as uncontrolled addiction. When used as prescribed, it stabilizes your brain and reduces the chaos of street opioid use, overdose risk, and constant withdrawal. Studies show that staying on buprenorphine treatment dramatically cuts the risk of relapse and death compared with going without medication.

How long will I need to stay on Suboxone?

There is no fixed time limit. Some people taper after a year or two of stability; others stay on it for many years. The highest risk of relapse is often when medication is stopped. Decisions about continuing or tapering should be made with your prescriber, based on your goals, stability, and support system.

Can I get high on Suboxone?

Most people taking Suboxone as prescribed do not feel a strong “high.” Instead, they feel normal or just less sick. Because buprenorphine only partially activates opioid receptors and has a ceiling effect, it is much harder to get euphoric effects compared with full opioids like heroin or oxycodone—especially once you are tolerant.

What happens if I take other opioids while on Suboxone?

Buprenorphine binds very strongly to opioid receptors, so other opioids may not work well unless you take very large (and dangerous) amounts. People sometimes keep increasing doses trying to override Suboxone, which can lead to overdose. This is one reason why having naloxone on hand and being honest with your prescriber is so important.

Can I drink alcohol while taking Suboxone?

You should avoid alcohol. Both Suboxone and alcohol slow brain activity and breathing. Together they can cause extreme sleepiness, dangerously slow breathing, or death—even if each alone might seem “low dose.”

Will I go into withdrawal if I start Suboxone too early?

Yes, that can happen. If buprenorphine is started while another opioid is still strongly attached to your receptors, it can suddenly push that drug off and trigger intense withdrawal—called precipitated withdrawal. To avoid this, your prescriber will ask you to wait until clear withdrawal signs appear before the first dose.

Is Suboxone safe during pregnancy?

Medication treatment for OUD during pregnancy is generally safer than ongoing uncontrolled opioid use. Many experts prefer buprenorphine alone when starting treatment in pregnancy, but people who are already stable on Suboxone may sometimes stay on it. This decision is individualized and should involve an obstetric and addiction-informed team.

Can I breastfeed while taking Suboxone?

In many cases, yes. Only small amounts of buprenorphine pass into breast milk, and breastfeeding can be encouraged in stable patients when there are no other contraindications. Your baby should be monitored for unusual sleepiness or feeding problems, and you should follow the plan your care team recommends.

What are the most common Suboxone side effects?

Headache, constipation, sweating, nausea, and sleep changes are the most frequent. Some people also report mouth irritation or dental issues with long-term use of films or tablets that dissolve in the mouth.

Can I overdose on Suboxone?

Yes, especially if combined with other sedating substances like alcohol, benzodiazepines, or sleep medicines. Buprenorphine has a “ceiling effect” on breathing depression compared with full opioids, but it is absolutely still possible to overdose. Having naloxone available and teaching your family or friends how to use it is strongly recommended.

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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