Suboxone

Opioid Use Disorder

Suboxone is used to treat adults who are dependent on or addicted to opioid drugs. This includes illegal drugs like heroin as well as prescription narcotic painkillers such as oxycodone, hydrocodone, codeine, and morphine.

Comprehensive Treatment Approach

The medication is intended for use as part of a complete treatment program for opioid use disorder. For the best results, it is combined with other recovery tools, such as:

• Counseling and behavioral therapy
• Psychosocial support services
• Medical supervision

Maintenance and Recovery

Suboxone is primarily used for maintenance treatment, helping to stabilize individuals in recovery by reducing cravings and preventing withdrawal symptoms. By managing these symptoms, the medication helps patients focus on their overall treatment and lifestyle changes necessary for long-term recovery.

Mechanism of Action

Suboxone contains two active ingredients that work in different ways to treat opioid use disorder:

• Buprenorphine: This is a partial opioid agonist. It attaches to the same receptors in the brain as other opioids, such as heroin or prescription pain relievers. Because it is a partial agonist, it provides enough stimulation to reduce cravings and prevent withdrawal symptoms, but it does not produce the same intense high as full opioids. It also has a ceiling effect, which means its effects do not increase significantly after a certain dose, reducing the risk of misuse and respiratory depression.
• Naloxone: This is an opioid antagonist, or blocker. It is included in the medication primarily to discourage people from injecting it. When Suboxone is taken correctly by dissolving it in the mouth, the naloxone has little to no effect. However, if the medication is crushed and injected, the naloxone enters the bloodstream quickly and blocks the effects of opioids, which can cause immediate and severe withdrawal symptoms.

Together, these ingredients help stabilize the brain chemistry of individuals with opioid dependence. This allows them to focus on recovery and therapy without the constant physical burden of withdrawal or intense drug cravings.

Common Side Effects

Many people using Suboxone experience mild side effects. These often include:

• Headache
• Nausea and vomiting
• Constipation
• Increased sweating
• Difficulty sleeping (insomnia)
• Pain, including back pain or stomach pain
• Swelling in the arms or legs
• Numbness, redness, or burning in the mouth where the film or tablet was placed

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Breathing problems: Slowed or shallow breathing, or extreme drowsiness.
• Liver issues: Yellowing of the skin or eyes (jaundice), dark-colored urine, light-colored stools, or pain in the upper right stomach area.
• Allergic reactions: Hives, skin rash, or swelling of the face, lips, tongue, or throat.
• Adrenal insufficiency: Symptoms such as nausea, vomiting, loss of appetite, dizziness, or worsening tiredness and weakness.
• Dental problems: Suboxone has been linked to tooth decay, cavities, and gum infections, even in patients with no history of dental issues.
• Low blood pressure: Feeling dizzy or faint when getting up from a sitting or lying position.
• Sleep apnea: New or worsening breathing interruptions during sleep.

If you experience symptoms of opioid withdrawal, such as shaking, goosebumps, or diarrhea, while taking this medication, consult your doctor as your dosage may need adjustment.

Respiratory Depression and Misuse

Suboxone contains buprenorphine, which can cause serious or life-threatening breathing problems, especially during the first few days of treatment or when the dose is increased. It also carries a risk of addiction, abuse, and misuse, which can lead to overdose and death. Accidental ingestion, particularly by children, is a medical emergency.

Interactions with Other Substances

Using Suboxone with benzodiazepines, alcohol, or other central nervous system depressants can lead to profound sedation, respiratory distress, coma, and death. It is important to discuss all medications and substances with a healthcare provider.

Liver Health

Cases of moderate to severe liver injury have been reported. Healthcare providers may perform blood tests to monitor liver function before and during treatment.

Dental Health

The FDA has issued warnings regarding serious dental problems associated with buprenorphine medications dissolved in the mouth. These issues include tooth decay, cavities, oral infections, and tooth loss, even in patients with no prior history of dental problems.

Precipitated Withdrawal

If Suboxone is taken while other opioids are still active in the body, it can cause sudden and severe withdrawal symptoms. This is known as precipitated withdrawal.

Pregnancy and Neonatal Opioid Withdrawal Syndrome

Long-term use of Suboxone during pregnancy can cause neonatal opioid withdrawal syndrome in the newborn, which may be life-threatening if not recognized and treated.

Adrenal Insufficiency

Chronic use of opioids may lead to adrenal insufficiency, a condition where the body does not produce enough of certain hormones. Symptoms may include nausea, vomiting, loss of appetite, fatigue, and dizziness.

Pregnancy

If you are pregnant or planning to become pregnant, talk to your doctor about the risks and benefits of using Suboxone. Untreated opioid use disorder during pregnancy can lead to serious complications, including low birth weight, premature birth, or fetal death. Medication-assisted treatment is often recommended to help maintain a stable environment for the pregnancy.

Using Suboxone throughout pregnancy may cause the baby to experience neonatal opioid withdrawal syndrome (NOWS). This is an expected condition where the baby goes through withdrawal from the medication after birth. Symptoms of NOWS can include:

• Irritability and high-pitched crying
• Difficulty sleeping or feeding
• Tremors or jitteriness
• Vomiting or diarrhea
• Failure to gain weight

NOWS is treatable, but it requires the baby to be monitored in a hospital setting for several days after delivery. Your healthcare team will help manage these symptoms to ensure the baby's safety.

Breastfeeding

The active ingredients in Suboxone, buprenorphine and naloxone, pass into breast milk in small amounts. Breastfeeding is generally encouraged for individuals on stable medication-assisted treatment, as the benefits of breastfeeding often outweigh the potential risks. However, it is important to monitor the nursing infant closely.

Watch the baby for signs of excessive sleepiness, limpness, or difficulty breathing. If you notice any of these symptoms, contact a healthcare provider or seek emergency medical care immediately. Discuss your breastfeeding plan with your doctor to determine the safest approach for you and your child.

Available Forms

Suboxone is primarily available as a sublingual film. This film is designed to be absorbed through the lining of the mouth rather than swallowed.

The film can be administered in two ways:

• Sublingual: Placed under the tongue until fully dissolved.
• Buccal: Placed against the inside of the cheek until fully dissolved.

While the brand-name Suboxone is a film, the combination of its active ingredients is also available in generic forms, such as sublingual tablets.

FDA Approval and Indication

Suboxone, a combination of buprenorphine and naloxone, is approved by the U.S. Food and Drug Administration (FDA) for the maintenance treatment of opioid dependence. It is intended for use as part of a comprehensive treatment plan that includes counseling and behavioral therapy.

Controlled Substance Status

The Drug Enforcement Administration (DEA) classifies Suboxone as a Schedule III controlled substance. This means it has a currently accepted medical use but also carries a potential for abuse and may lead to moderate or low physical dependence or high psychological dependence.

Risk Evaluation and Mitigation Strategy (REMS)

Because of the risks associated with buprenorphine-containing products, the FDA requires a Risk Evaluation and Mitigation Strategy (REMS). The goal of this program is to mitigate the risks of accidental overdose, misuse, and abuse, and to inform patients about the serious risks associated with these medications.

Major Safety Communications

The FDA has issued specific safety communications regarding the use of Suboxone and similar products:

• Dental Health: In 2022, the FDA issued a warning that buprenorphine medicines dissolved in the mouth have been linked to serious dental problems, including tooth decay, cavities, and oral infections. These issues can occur even in patients with no prior history of dental problems.
• Use with CNS Depressants: The FDA has advised healthcare providers not to withhold opioid addiction medications from patients taking benzodiazepines or other central nervous system (CNS) depressants. While combining these drugs increases the risk of respiratory depression, the FDA notes that the risks of untreated opioid addiction often outweigh these concerns.

Opioid Withdrawal Symptoms

Because Suboxone contains buprenorphine, a partial opioid agonist, the body can develop a physical dependence on the medication over time. If treatment is stopped abruptly, you may experience withdrawal symptoms as your body adjusts to the absence of the drug. These symptoms may include:

• Nausea, vomiting, or diarrhea
• Muscle aches and body pains
• Sweating, chills, or goosebumps
• Anxiety, irritability, or restlessness
• Trouble sleeping (insomnia)
• Runny nose or watery eyes

Precipitated Withdrawal

Suboxone can also cause a condition known as precipitated withdrawal. This occurs if the medication is taken while other full-agonist opioids (such as heroin or prescription pain relievers) are still active in the system. Because buprenorphine binds more strongly to opioid receptors than most other drugs, it can suddenly displace those other opioids, causing intense withdrawal symptoms to begin very rapidly.

Safe Discontinuation

To minimize the risk of withdrawal, healthcare providers typically recommend a gradual dose reduction, often called a taper. A doctor will create a schedule to slowly lower the amount of medication taken over several weeks or months. It is important not to stop taking Suboxone or change the dosage without professional guidance, as a controlled taper helps the body adjust safely and reduces the risk of relapse.