Buprenorphine (Suboxone)

Emergency & Prehospital

• Moderate opioid withdrawal in opioid use disorder (OUD): Start buprenorphine once objective signs of moderate withdrawal show up. The time since the last full-agonist dose also has to be long enough (see Dosing). The NAEMSP 2026 position statement supports prehospital buprenorphine under low-barrier protocols where scope allows
• Naloxone-precipitated or post-overdose withdrawal: Buprenorphine can treat the withdrawal, and maintenance can start in the field. Protocol-dependent
• Acute severe pain: Buprenorphine hydrochloride IV or IM is labeled for pain severe enough to need an opioid. Use it when the alternatives fall short

ED / ICU / Transport

• OUD induction in the emergency department: Sublingual (SL) buprenorphine started in the ED, with referral for ongoing care (see Dosing for fentanyl-era options)
• OUD maintenance: SL film or tablet, usually buprenorphine with naloxone for unsupervised dosing
• Long-acting injectables: Sublocade (monthly, subcutaneous) and Brixadi (weekly or monthly, subcutaneous) for patients established on buprenorphine
• Analgesia in patients on buprenorphine: Keep buprenorphine going. Under supervision, a full agonist may be needed at higher analgesic doses (see Clinical Pearls)
• Fentanyl-positive patients: Induction timing and dosing are different from heroin-dependent patients. See Dosing (fentanyl-era induction)

Other Uses

• Opioid use disorder in pregnancy: Buprenorphine is used in pregnancy when the benefit outweighs the risk. Neonatal opioid withdrawal syndrome (NOWS) is an expected, treatable outcome (see Special Populations)
• Other buprenorphine products for chronic pain (buccal film, transdermal patch) fall outside this page

Doses vary by protocol; follow local protocols and medical direction.

Available Forms

• Sublingual film, buprenorphine/naloxone (Suboxone and generics): 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg and 12 mg/3 mg per film (label)
• Sublingual tablet, buprenorphine alone (generics): 2 mg and 8 mg. Labeled for induction. Buprenorphine/naloxone is preferred after induction (label)
• Sublocade (buprenorphine extended-release solution): Subcut monthly depot. Only a health care provider gives it. Maintenance is 100 mg (300 mg may be considered)
• Brixadi (buprenorphine injection): Subcut weekly or monthly depot. Only a health care provider gives it. Weekly and monthly strengths follow the label
• Buprenorphine hydrochloride injection, 0.3 mg base/mL: 1 mL single-dose cartridge (0.3 mg) for IV or IM use (Buprenex-type label)

Adult Dosing

Pediatric Dosing

Preparation & Administration

• Sublingual: place film or tablet under the tongue and let it dissolve completely; do not swallow. Keep the sublingual site during induction (buccal absorption gives more naloxone exposure)
• IV or IM (buprenorphine HCl): IV slowly over at least 2 minutes; deep IM. Protect from light (carton label)
• Depot injections (Sublocade, Brixadi): subcut only, into the abdomen, thigh, buttock or back of the upper arm; rotate sites; never IV, IM or intradermal
• Sublocade handling: keep refrigerated; allow at least 15 minutes to reach room temperature; do not open the pouch until the patient is ready; discard if left at room temperature longer than 12 weeks
• Observation: monitor depot recipients in a health care setting until withdrawal and sedation are stable before release

Contraindications

• Known hypersensitivity to buprenorphine or a product component (Sublocade: ATRIGEL delivery system; Brixadi: hypersensitivity including anaphylaxis; Suboxone: buprenorphine or naloxone)
• Buprenorphine injection: significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment; known or suspected GI obstruction including paralytic ileus

Precautions

• Full-agonist dependence: Buprenorphine can precipitate withdrawal when it is given too soon after heroin, fentanyl or another short-acting opioid. The minimum wait is 6 hours per the Sublocade and Suboxone film labels. The generic SL tablet label says 4 hours. After a long-acting opioid such as methadone, wait at least 24 hours. The risk rises with methadone above 30 mg daily. The labels set fixed minimums only. After recent or heavy fentanyl use, see Dosing (fentanyl-era induction)
• Benzodiazepines, alcohol and other CNS depressants: Additive respiratory depression, coma and death. The label says not to withhold OUD treatment for this reason
• Compromised breathing (COPD, cor pulmonale, hypoxia, hypercapnia). Use caution. If a depot is stopped for respiratory compromise, keep monitoring for months
• Hepatic impairment: Levels rise and the half-life lengthens in moderate and severe impairment. Sublocade is not for patients with pre-existing moderate to severe hepatic impairment. Brixadi is not recommended in moderate to severe impairment (labels). Avoid Suboxone film in severe impairment. It may not be appropriate in moderate impairment
• QT prolongation: Thorough QT studies show prolongation of 15 ms or less. The label's risk factors include hypokalemia, bradycardia, digitalis, heart failure, baseline QT prolongation and severe hypomagnesemia
• Abdominal and neurologic presentations: Buprenorphine may obscure the diagnosis of an acute abdomen. It can raise cerebrospinal fluid pressure (Brixadi label)
• Opioid-naive patients (Brixadi): Not appropriate. This is a label warning, not a contraindication. The label reports deaths in opioid-naive people who took a 2 mg SL tablet

Hold / Reassess If

• Sedated at the time of a scheduled dose: delay or omit the buprenorphine dose (Sublocade label)
• Breathing inadequate for age, or SpO₂ falling: stop further buprenorphine, ventilate, and give naloxone per the naloxone page; keep ventilating while naloxone acts
• Withdrawal signs not yet moderate on an SL induction: do not start; reassess and wait out the labeled interval
• Hypokalemia, hypomagnesemia, bradycardia or a QT-prolonging drug added: obtain an ECG and correct electrolytes before the next dose
• Moderate or severe hepatic impairment on SL therapy: monitor for toxicity (label). Buprenorphine-alone SL tablets: halve the starting and titration doses in severe impairment (tablet label)

Common

• Opioid-type effects: nausea, vomiting, constipation, headache, dizziness, sweating
• Sedation, especially during induction and after dose increases
• Oral effects with SL products: local irritation at the sublingual site
• Injection-site reactions with depot products: pain, nodules, local reactions
• Withdrawal symptoms when doses are missed or stopped abruptly (milder and later than with full agonists)

Serious / Life-Threatening

Overdose & Toxicity Management

• Toxidrome: pinpoint pupils, sedation, hypotension, hypoglycemia, respiratory depression and death. Toxic leukoencephalopathy can appear days to weeks after the patient seems to recover (SL label)
• Immediate care: protect the airway and ventilate; oxygen, IV fluids and vasopressors as indicated (SL label)
• Naloxone: adult 0.2–2 mg IV, IO or IM (2025 AHA Part 10; differs from FDA label: 0.4–2 mg IV), or 2–4 mg IN, repeated every 2–3 minutes. Buprenorphine may need higher and repeated doses. Pediatric and adult detail on the naloxone page
• Prolonged observation: The SL half-life is about 24–42 hours (31–35 in the tablet label). Depot products can persist for months. Don't discharge early after a reversal
• Poison information: call poison control (1-800-222-1222) for complex or pediatric exposures

IV Compatibility

• Buprenorphine HCl injection: The label gives no Y-site compatibility data. Avoid co-infusion through the same line unless it has been checked
• Sublocade and Brixadi: never given IV; do not place in an IV line
• Verify with an institutional compatibility resource.

• Pediatrics: Pain dosing is established from age 2 years under the injection label (see Pediatric Dosing). OUD products are not established in children. Accidental exposure can be fatal
• Neonates: Neonatal opioid withdrawal syndrome is an expected, treatable outcome of maternal treatment. The naloxone-containing combination is not appropriate for neonatal abstinence syndrome
• Pregnancy: Untreated opioid use disorder is linked to low birth weight, preterm birth and fetal death. Human data do not show an increased risk of major malformations from buprenorphine. Sublocade animal data show embryolethality and malformations at multiples of the human dose. Part of that is attributed to the vehicle. Labor may need extra analgesia
• Lactation: Buprenorphine passes into breast milk. The label advises watching the infant for drowsiness and breathing difficulty
• Older Adults: Start the buprenorphine injection at the low end of the range and titrate slowly. Watch for respiratory and CNS depression (injection label)
• Renal Impairment: The label gives no dose adjustment. In dialysis-dependent patients, buprenorphine kinetics after 0.3 mg IV were no different from normal patients
• Hepatic Impairment: Levels rise and the half-life lengthens in moderate and severe impairment. For buprenorphine-alone SL tablets, halve starting and titration doses in severe impairment. Avoid buprenorphine/naloxone film in severe impairment. It may not be appropriate in moderate impairment. Sublocade is not for moderate to severe pre-existing impairment. Brixadi is not recommended in moderate to severe impairment
• Obesity / Dosing Weight: Adult OUD doses are fixed, not weight-based. Pediatric pain dosing is per kg. No specific obesity adjustment is established
• Opioid-Naive Patients: Not appropriate for Brixadi. Deaths have been reported after a 2 mg SL tablet in opioid-naive people

• Scope: EMS and transport use varies by state and agency protocol. The NAEMSP 2026 statement recommends scope and low-barrier protocols for prehospital buprenorphine
• Storage & Stability: Protect the injection from light. Sublocade is refrigerated. It needs 15 minutes to reach room temperature. Discard it if it is left at room temperature for more than 12 weeks
• Carried Concentration: The injection is 0.3 mg/mL. SL film and tablets come in several milligram strengths. Confirm the strength and form before dosing
• Infusions in Transport: none labeled for buprenorphine
• Example induction elements (protocol-specific): objective moderate withdrawal (COWS about 8 or higher) before the first dose; an initial transmucosal dose of 2–4 mg SL; reassess before any further dose (titration about every 2 hours); naloxone per the naloxone page if breathing falls; a referral or bridge prescription at handoff
• Handoff Essentials: time and dose of last buprenorphine or depot injection (next dose due); time and type of last opioid use; withdrawal score before dose; response, sedation and breathing after dose

Mechanism of Action

• Target: partial agonist at the mu-opioid receptor
• Physiologic effect: Opioid effects plateau with dose. That means less respiratory depression, and milder, later withdrawal than with full agonists (labels)
• Clinical consequence: It can precipitate withdrawal in full-agonist dependence. Reversal by naloxone can be incomplete or slow

Pharmacokinetics

• Half-life: SL about 24–42 hours (Suboxone film label; 31–35 hours in the generic tablet label); IV (postoperative) 1.2–7.2 hours, mean 2.2 hours; subcut depots as above
• Metabolism: N-dealkylation to norbuprenorphine, mainly by CYP3A4, then glucuronidation
• Active metabolites: Norbuprenorphine binds opioid receptors in vitro. Its clinical activity is not established
• Elimination: urine and feces; 30% and 69% of an SL radiolabeled dose recovered in urine and feces over 11 days
• Protein binding: about 96%, mainly alpha and beta globulin

Generic name

Buprenorphine (buprenorphine hydrochloride for SL and injection; buprenorphine for subcut depots)

Brand names (US)

Suboxone (buprenorphine/naloxone sublingual film); Sublocade; Brixadi; Buprenex-type buprenorphine injection (Carpuject); generic SL tablets and buprenorphine/naloxone film and tablets. Zubsolv (buprenorphine/naloxone SL tablet) is also marketed

Pharmacologic class

Partial mu-opioid receptor agonist

Therapeutic class

Opioid use disorder treatment; opioid analgesic (injection)

Controlled substance

C-III

ISMP high-alert

Yes: IV opioid (verify against the current ISMP acute-care list)

Look-alike / sound-alike

None commonly reported; confirm the product form (SL, depot or injection) before dosing