From the Guidelines
Yes, it is possible to overdose on Suboxone (buprenorphine/naloxone), particularly in individuals without opioid tolerance or when combined with other central nervous system depressants like alcohol, benzodiazepines, or other opioids. Suboxone overdose can occur due to various factors, including the presence of other substances that may magnify opioid effects on respiration, as noted in a study published in the Annual Review of Medicine 1. Symptoms of overdose include extreme drowsiness, pinpoint pupils, respiratory depression, blue lips or fingernails, unconsciousness, and potentially death. The risk is higher in children who accidentally ingest the medication and in opioid-naive individuals. Buprenorphine has a "ceiling effect" on respiratory depression when used alone, which provides some safety compared to full opioid agonists, but this protection is not absolute.
According to the 2024 American Heart Association and American Red Cross guidelines for first aid, opioid overdose is a leading cause of death in the United States and worldwide, with more than 80,000 people in the United States dying of opioid overdose in 2021 1. If you suspect a Suboxone overdose, call emergency services (911) immediately. Naloxone (Narcan) can reverse the effects temporarily, but medical attention is still required as buprenorphine has a longer duration of action than naloxone. To prevent overdose, take Suboxone exactly as prescribed, store it safely away from children, and never combine it with other sedating substances without medical supervision.
Some key points to consider in preventing and managing Suboxone overdose include:
- Taking the medication exactly as prescribed
- Storing it safely away from children
- Avoiding combination with other sedating substances without medical supervision
- Being aware of the signs and symptoms of overdose, such as extreme drowsiness and respiratory depression
- Knowing how to respond in case of an overdose, including calling emergency services and administering naloxone if available. The use of naloxone in reversing opioid overdose effects is supported by guidelines, including those from the American Heart Association, which highlight its safety profile and effectiveness in emergency settings 1.
From the FDA Drug Label
OVERDOSAGE Clinical Presentation Acute overdose with buprenorphine can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death Abuse of and addiction to opioids in some individuals may not be accompanied by concurrent tolerance and symptoms of physical dependence. In addition, abuse of opioids can occur in the absence of addiction Misuse and abuse of buprenorphine hydrochloride increases risk of overdose, which may lead to central nervous system and respiratory depression, hypotension, seizures, and death
Yes, it is possible to overdose on Suboxone. The risk of overdose is increased with concurrent abuse of Suboxone with alcohol and/or other CNS depressants. Symptoms of overdose include respiratory depression, somnolence, and skeletal muscle flaccidity, and can be fatal if not immediately recognized and treated. 2 2
From the Research
Overdose Risk on Suboxone
- Suboxone, which contains buprenorphine and naloxone, has a unique pharmacology that distinguishes it from other opioid drugs, with a ceiling effect on sedation and respiratory depression, suggesting a wider safety margin compared to other opioid drugs 3.
- Studies have shown that buprenorphine/naloxone has a favorable safety profile compared to other opioid drugs and other classes of psychotropic drugs, with less cardiorespiratory depression compared to buprenorphine alone 3.
- However, cases of fatal opioid overdose with buprenorphine on postmortem toxicology have been reported, often involving polysubstance use, with an average of 9.24 co-exposures in fatalities with buprenorphine detected on toxicology testing 4.
Factors Influencing Overdose Risk
- The risk of overdose on suboxone may be influenced by factors such as polysubstance use, with co-exposures to other substances like fentanyl, cocaine, and benzodiazepines increasing the risk of overdose 4.
- The use of benzodiazepines during buprenorphine treatment has been associated with more frequent emergency department visits and accidental injuries, especially among females 5.
- Individual patient characteristics, such as medical or psychiatric conditions, and preferences should be taken into consideration when choosing a treatment option, with buprenorphine-naloxone recommended for socially stable prescription oral opioid users or those at high risk of methadone toxicity 6.
Clinical and Safety Outcomes
- Studies have shown that buprenorphine-naloxone treatment is effective in reducing opioid use and improving treatment retention, with a lower risk of overdose compared to methadone treatment 6.
- However, the clinical benefit of prescribing benzodiazepines during buprenorphine treatment is unclear, with concerns remaining about overdose, accidental injury, and benzodiazepine misuse 5.
- Further research is needed to explore the use of postmortem concentrations of buprenorphine and other opioid metabolites to determine the role of buprenorphine in fatal overdose pharmacology 4.