Buprenorphine/Naloxane or Suboxone

Buprenorphine/Naloxane or Suboxone

What it is

Buprenorphine/Naloxone or Suboxone is usually taken daily and must be dissolved under the tongue. It should never be chewed or swallowed. It has lower abuse potential and can have milder withdrawal symptoms than methadone. It does not have the same level of euphoric effects or as great of an overdose risk as other opioid drugs.

Buprenorphine is widely available in a formula that contains added naloxone, which discourages abusing or injecting it. It also is made in a formula with just the single drug and no added naloxone, which is sometimes used for Medicaiton Assisted Treatment (MAT) with pregnant women and people who are switching from methadone.

What it does 

Both forms of buprenorphine control withdrawal symptoms and block cravings. People taking a prescribed dose of buprenorphine that is right for them, feel normal, can continue to work, and can usually perform tasks like driving.

Where do you get it?

Doctors can complete a required training and certification process that allows them to prescribe buprenorphine to treat opioid use disorder. They can prescribe buprenorphine to patients they see in their office or for clients in treatment programs. At the beginning of treatment, patients seen at a doctor’s office usually have frequent appointments, are referred to attend counseling, and are monitored to ensure they are making satisfactory progress. Then they may receive a prescription to take at home.

Cost

Buprenorphine is typically more expensive than Methadone, but less expensive than Naltrexone. However, the real cost to an individual varies depending on the state where the person lives, health insurance coverage, and other factors. The provider will have information about real cost and payment options.

Who it works for

Most guidelines suggest people with shorter, less extensive histories of heavy opioid use may be good candidates for treatment with buprenorphine. It also works for more severe opioid use disorder and for people who decide to switch from methadone. It offers a safe and effective alternative for those unable to get to an opioid treatment program on a regular basis and for pregnant women seeking treatment. It works best for people who are able to adhere to a treatment plan and take the medication as directed.

Research outcomes

Since buprenorphine was approved for MAT only a few years ago, in comparison to methadone, there are fewer long-term studies of safety and effectiveness. So far the research suggests that long-term treatment with buprenorphine is safe and very effective when combined with counseling and recovery support. Several recent studies on buprenorphine have shown it can be used to safely treat opioid use disorder during pregnancy. This research also suggests that although infants born to mothers treated with buprenorphine are at-risk for withdrawal, their symptoms tend to be milder. They are less likely to require treatment with medications and have shorter hospital stays than infants born to mothers treated with methadone.

Starting buprenorphine

It is necessary to wait 12–24 hours after the last opioid use before starting buprenorphine in order to avoid uncomfortable symptoms.

After the first dose, people typically stay at the doctor’s office or treatment center for a few hours while the doctor or nurse checks on them regularly to watch their reaction. If withdrawal symptoms are a problem, dosages can be adjusted.

Side effects

Most people have some side effects from buprenorphine such as headache, nausea, and constipation. Some people using buprenorphine for long-term MAT have reported sexual side effects or liver problems.

Warnings

Some warnings are listed below. For complete information, see the list of websites at the end of this section.

  • Moderate risk of overdose.
  • High risk of overdose when combined with benzodiazepines (Valium, Ativan, Xanax).
  • High risk of overdose when combined with other substances, including alcohol.
  • Possible risk of liver damage.
  • Risk of driving impairment at the start of treatment or during dosage adjustments.
  • May affect ability to get a commercial driver’s license (CDL) in some states.

All medications can interact with alcohol, other prescription and over-the-counter medications, as well as vitamins, herbs, and supplements. If you use alcohol or other drugs in addition to opioids, your situation may be more complex. Talk to your doctor about all the medications and substances you use. You can search for medication interactions at Avoiding Drug Interactions.

Risks to others

All medications should be stored in a locked cabinet out of reach of children or pets. Doses tolerated by some individuals can cause serious harm, even death, to others. Excess medication should be disposed of properly. Medications should only be taken by the person they were prescribed for.

How long do I need to take it?

The decision about how long to take buprenorphine is made by the individual with their doctor. Most current research shows that the longer people are treated with buprenorphine, the more positive the results. Research shows that treatment lasting more than nine months decreases the chance of returning to drug use. It is safe to stay on buprenorphine for a long time. When they are ready, most people work with their doctor to slowly reduce the dose of buprenorphine. The withdrawal symptoms tend to be milder than symptoms people have when they discontinue methadone.

Pregnancy

Although there are fewer long-term studies available on buprenorphine treatment during pregnancy, so far a substantial amount of research has shown it can be used safely to treat women who are pregnant or breastfeeding. As with any treatment, there are some risks; but they are not nearly as high as the risks pregnant women with untreated opioid use disorder may face. Infants born to mothers treated with buprenorphine during pregnancy are at risk for experiencing withdrawal, but the symptoms tend to be milder and may be easier to manage. These newborns are less likely to require medication for withdrawal symptoms and spend less time in the hospital than newborns whose mothers are treated with methadone. There is no evidence of any permanent effects, and current medical guidelines consider buprenorphine an option for pregnant women who prefer it, or are already taking it.

Use of buprenorphine only, in the single drug formula, has been studied in pregnant women. Compound formulas that contain naloxone are not recommended for pregnant women, since it has not been tested for safety.

HIV/AIDS

Buprenorphine may be used by people with HIV/AIDS. There are fewer interactions with HIV drugs than with methadone. It is possible that it may still interact with some HIV medications and require an adjusted dose. Talk with your doctors about your situation.

Hepatitis and liver disease

People with liver disease should check with their doctors before starting buprenorphine. It is possible it may contribute to liver damage, especially in people who already have a liver condition. Combination products containing naloxone should not be used if patients have severe liver impairment. Liver function tests are recommended before beginning buprenorphine. Studies have shown it can be used safely by people with hepatitis who are being treated with interferon. Talk with your doctors about your situation.

Pain

People who use buprenorphine for MAT often have a high tolerance to opioid pain medications. It can be difficult to relieve their pain at a typical dosage. Buprenorphine, in high doses, may decrease the effectiveness of other opioids used to manage pain. People with chronic pain who are using buprenorphine for MAT can benefit from working with a doctor who is experienced with pain management for people with histories of opioid use disorder.

Talk to your doctor if you need pain relief and are taking buprenorphine for MAT.

Legal issues

  • Buprenorphine does not affect the ability to get a driver’s license, as long as the person is not using illegal drugs or abusing prescription medications.
  • Buprenorphine may affect eligibility for commercial driver’s licenses in some states.
  • People receiving buprenorphine treatment are protected by confidentiality laws and anti-discrimination laws as long as they are not using illegal drugs or abusing prescribed medications.
  • Buprenorphine may show up on a drug screen.
  • An employer legally cannot fire you for being treated with buprenorphine as long as you can document that it is prescribed as part of your medical treatment.
  • People involved with the criminal justice system may have a difficult time getting buprenorphine while in jail or prison, or while under court supervision.

 

For more information

More information about buprenorphine 

www.nlm.nih.gov/medlineplus/druginfo/meds/a605002.html

FDA approved package inserts and product labeling:

https://www.dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=human&query=BUPRENORPHINE

The Facts About Buprenorphine 

www.store.samhsa.gov/product/The-Facts-about-Buprenorphine-for-Treatment-of-Opioid-Addiction/SMA14-4442

Know Your Rights: Rights for People on MAT 

www.lac.org/doc_library/lac/publications/Know_Your_Rts_-_MAT_final,_9.28.10.pdf

Who it works for?

  • Motivated to try buprenorphine for MAT
  • Are best treated in doctors’ offices
  • Pregnant and postpartum women
  • People being treated for HIV/AIDS
  • Able to follow a treatment plan

 

Side effects

Most people have some side effects.

Talk to your doctor if they are severe or do not go away.

Some examples of side effects reported by people taking buprenorphine are listed below. This is not a complete list of all possible side effects. See product labeling for more information:

  • Headache
  • Stomach or back pain
  • Constipation
  • Nausea or Vomiting
  • Difficulty falling asleep or staying asleep
  • Sweating
  • Mouth numbness, redness, or sores
  • Tongue pain, swelling, or burning
  • Excess fluid and swelling of feet or legs
  • Blurred vision
  • Intoxication (feeling lightheaded or drunk)
  • Disturbance in attention
  • Irregular heart beat (palpitations)
  • Fainting
  • Dizziness
  • Sleepiness

 

Serious side effects are not as common. Contact medical help if you have:

  • Hives or Skin rash
  • Itching
  • Difficulty breathing or swallowing
  • Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • Upset stomach, nausea
  • Extreme tiredness
  • Blurred vision
  • Slurred speech
  • Confusion or cannot think clearly
  • Unusual bleeding or bruising
  • Lack of energy or coordination
  • Loss of appetite
  • Pain in the upper right part of the stomach
  • Yellowing of the skin or eyes
  • Dark-colored stools
  • Light-colored stools
  • Have slowed reflexes and breathing
  • Diziness when changing positions

 

Buprenorphine

Common forms

  • Film or pill
  • Other forms; seldom used for treating addiction

 

How do I take it?

  • Usually taken daily; must dissolve under the tongue or in mouth.
  • Offered in various treatment programs
  • Trained physicians provide it for office-based treatment
  • Patients may get a prescription to take at home.
  • Can be filled at any pharmacy

 

Cost

  • Cost varies depending on state, insurance, and other factors. Talk to provider about payment options.

 

Buprenorphine

Pregnancy and breastfeeding

  • Studies show buprenorphine safe during pregnancy and breastfeeding
  • The form of buprenorphine that that does not contain naloxone is recommended during pregnancy and breast-feeding.
  • Risk of withdrawal symptoms in infants born to mothers treated with buprenorphine during pregnancy

 

HIV

  • May be used during HIV treatment. Smaller risk of drug interactions; talk with your doctors

 

Hepatitis

  • The form of buprenorphine that contains naloxone should not be used if patients have severe liver impairment.
  • Has been used safely by people with hepatitis. Liver damage reported mostly in people who already had liver conditions. Check with your doctor. Liver function tests recommended.

 

Chronic pain

  • At high doses, buprenorphine can cancel out pain relieving effects of other opioid pain medications.
  • Buprenorphine dosing for pain should be monitored carefully for overdose risk

 

Buprenorphine

When can I start?

  • 12–24 hours after last use

 

How long do I take it?

  • Most effective when used for 9 months or longer
  • Considered safe for long-term use
  • Periodic assessment of ongoing treatment needs based on what is right for you

 

What happens if I stop?

  • Withdrawal, less intense, but unpleasant
  • Withdrawal cannot be entirely “avoided” by gradually decreasing the buprenorphine dose.
  • It is advisable to work with your doctor to gradually decrease your dose.

 

What if I use opioid drugs on this medication?

  • Moderate risk of overdose
  • May cancel out pain relieving effects of other opioids

Buprenorphine

Overdose

  • Moderate to high risk when combined with alcohol and/or other substances
  • High risk when combined with benzodiazepines

 

Other health risks

  • High dosages may stop a person’s breathing

 

Risks to others

  • Dosages used in MAT may be harmful if shared or given to others
  • Can be fatal if taken by children, pets, or others with no tolerance
  • Must be stored safely in locked cabinet
  • Risk of impaired driving when starting or adjusting medication