What is Suboxone?

Suboxone (buprenorphine/naloxone) is a brand-name prescription drug. It’s used to treat dependence on opioid drugs.

Suboxone comes as an oral film that’s placed under your tongue (sublingual) or between your gums and cheek (buccal). The film dissolves in your mouth.

Suboxone contains two drugs in each film: buprenorphine and naloxone. It’s available in four strengths:

  • 2 mg buprenorphine / 0.5 mg naloxone
  • 4 mg buprenorphine / 1 mg naloxone
  • 8 mg buprenorphine / 2 mg naloxone
  • 12 mg buprenorphine / 3 mg naloxone

Studies show that Suboxone is effective for reducing opioid misuse. It’s also effective for keeping people with opioid dependence in treatment over a period of 24 weeks. (How well a drug such as Suboxone performs is partly assessed based on how long people stay in treatment.)

Is Suboxone a controlled substance?

Yes, Suboxone is a controlled substance. It’s classified as a schedule three (III) prescription drug. This means that it has an accepted medical use, but it may cause physical or psychological dependence and may be abused.

The government has created special rules for how schedule III drugs can be prescribed by a doctor and dispensed by a pharmacist. Your doctor or pharmacist can tell you more.

Doctors can only prescribe this drug for opioid dependence after receiving special training and certification through the U.S. federal government.

Suboxone generic

Suboxone is a brand-name drug that contains two ingredients: buprenorphine and naloxone.

Suboxone is also available in a generic version. The generic version comes in two forms: an oral film and an oral tablet. Both the film and the tablet are sublingual forms, which means you place them under your tongue to dissolve. The film can also be placed between your gums and cheek to dissolve (buccal).

Suboxone side effects

Suboxone can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Suboxone. This list does not include all possible side effects.

For more information on the possible side effects of Suboxone, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Suboxone include:

  • headache
  • opioid withdrawal symptoms, such as body aches, abdominal cramps, and rapid heart rate
  • anxiety
  • insomnia (trouble sleeping)
  • sweating
  • depression
  • constipation
  • nausea
  • weakness or fatigue
  • back pain
  • burning tongue
  • redness in the mouth

Some of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Serious side effects from Suboxone aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Serious side effects can include the following:

  • severe allergic reaction
  • abuse and dependence
  • breathing problems
  • coma
  • hormone problems (adrenal insufficiency)
  • liver damage
  • severe withdrawal symptoms

See below for information about each serious side effect.

Severe allergic reaction

Serious allergic reactions including anaphylaxis can occur in some people who take Suboxone. Symptoms of an allergic reaction can include:

  • trouble breathing
  • skin rash or hives
  • swelling of the lips, tongue, throat

If you have an allergic reaction to this drug, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

Abuse and dependence

Suboxone has opioid effects, and long-term use can lead to physical and psychological dependence. Suboxone dependence can cause drug-craving and drug-seeking behavior, which may lead to misuse or abuse.

Abuse can cause overdose and dangerous side effects, including death. This is especially true if Suboxone is used along with other opioids, alcohol, benzodiazepines (such as Ativan, Valium, or Xanax), or other drugs.

If you’re physically dependent on Suboxone and abruptly stop taking it, you could have mild withdrawal symptoms, such as nausea, headache, and muscle aches. These symptoms can be avoided by slowly tapering the dose of the medication before completely stopping.

Breathing problems and coma

Taking high doses of Suboxone can cause severe breathing problems, coma, and death.

These effects are more likely to occur when Suboxone is misused or abused. They’re also more likely when Suboxone is used together with other drugs such as opioids, alcohol, or benzodiazepines (such as Ativan, Valium, or Xanax).

Breathing problems are also more likely to occur in people who already have a breathing problem, such as chronic obstructive pulmonary disease (COPD).

Hormone problems

Some people who take opioids such as Suboxone for several weeks can have reduced cortisol hormone levels. This condition is called adrenal insufficiency. Symptoms can include:

  • nausea
  • vomiting
  • diarrhea
  • loss of appetite
  • fatigue and weakness
  • dizziness
  • low blood pressure
  • depression

Liver damage

Both mild and severe liver damage has occurred in people taking Suboxone. In some cases, this may have been due to a hepatitis infection or other causes. However, in other cases, Suboxone may have been the cause.

During your treatment with Suboxone, your doctor may do blood tests to check your liver function. If you have symptoms of liver damage, you may need to stop taking Suboxone. Symptoms of liver damage can include:

  • stomach pain
  • fatigue
  • yellowing of your skin or the whites of your eyes

Severe withdrawal symptoms

Suboxone contains naloxone. It’s included in Suboxone solely to help prevent abuse of the medication. Because of this ingredient, you could have severe withdrawal symptoms if you abuse Suboxone.

Naloxone is an opioid antagonist, which means it blocks the effects of opioid drugs. If you’re dependent on other opioids and you use Suboxone as an injection to shoot up, it will block the effects of any opioids in your system. This could lead to immediate opioid withdrawal symptoms.

But using the Suboxone film in your cheek or under your tongue won’t cause these severe withdrawal symptoms. That’s because the film doesn’t release as much naloxone into your system.

However, using the film could cause withdrawal symptoms if it’s taken while you still have other opioids in your system. That’s why it’s meant to be used only after the effects of opioids begin to wear off and you start to have withdrawal symptoms.

Avoiding withdrawal symptoms

Suboxone should only be used with short-acting opioids. This is because use with long-acting opioids will cause increased withdrawal symptoms. Short-acting opioids include heroin, codeine, morphine, and oxycodone (Roxicodone, RoxyBond).

Also, when used for induction treatment (see “How Suboxone works” below), Suboxone should be used under your tongue rather than in your cheek. When you use Suboxone film in your cheek, your body absorbs more naloxone, and withdrawal symptoms are more likely.

Long-term side effects

Suboxone is often used long-term for maintenance treatment of opioid dependence. Long-term use of Suboxone may increase the risk of certain side effects, such as:

  • hormone problems such as adrenal insufficiency
  • liver damage
  • abuse and dependence

Taking any opioid medication long-term, including Suboxone, can cause physical dependence. But long-term use of Suboxone can make it easier to stop abusing other opioids by reducing severe withdrawal and drug cravings.

When it comes time to stop taking Suboxone, your doctor will have you slowly taper off the medication to prevent withdrawal.

Constipation

Constipation is a common side effect of Suboxone. In one study, constipation occurred in about 12 percent of people taking Suboxone. If this side effect doesn’t go away or becomes severe, talk with your doctor. Your doctor may recommend treatment to relieve and prevent constipation.

Headache

Headache is a common side effect of Suboxone. In one study, headache occurred in about 36 percent of people taking Suboxone. This side effect may go away with continued use of the drug.

Weight loss or weight gain

Weight gain or weight loss are not side effects that have been reported in studies of Suboxone. However, some people who take Suboxone have reported having weight gain. It’s not known if Suboxone was the cause.

Rash

Rash is not a common side effect of Suboxone. However, some people who take Suboxone may get a rash if they have an allergic reaction to the drug. The most common symptoms of an allergic reaction to Suboxone are rash or hives and itchy skin.

If you have a rash while taking Suboxone, talk with your doctor. You may need a different treatment. (If you also have other symptoms, such as swelling of your face or trouble breathing, call your doctor or local poison control center right away. This could be a serious allergic reaction. If your symptoms are severe, call 911 or go to the nearest emergency room.)

Sweating

Sweating is a common side effect of Suboxone. In a study, sweating occurred in about 14 percent of people taking Suboxone. This side effect may go away with continued use of the drug.

Hair loss

Hair loss is not a side effect that has been reported in studies of Suboxone. However, some people who take Suboxone have reported having hair loss. It’s not known if Suboxone was the cause.

Insomnia

Insomnia (trouble sleeping) is a common side effect of Suboxone. In one study, insomnia occurred in about 14 percent of people taking Suboxone. This side effect may go away with continued use of the drug.

Driving problems

Suboxone can impair your ability to drive. If you feel lightheaded or sleepy after taking it, don’t drive. Also, don’t use dangerous equipment.

Brain damage

Brain damage is not a side effect that has been reported in people taking Suboxone.

Suboxone uses

The Food and Drug Administration (FDA) approves prescription drugs such as Suboxone to treat certain conditions. Suboxone may also be used off-label for other conditions.

Suboxone for opioid dependence

Suboxone is FDA-approved to treat opioid dependence. According to the American Society of Addiction Medicine, Suboxone is a recommended treatment for opioid dependence. It helps treat opioid dependence by reducing the withdrawal symptoms that can occur when opioid use is stopped or reduced.

Suboxone for withdrawal

Suboxone is sometimes used off-label to help manage opioid withdrawal symptoms as part of a detoxification program. It may help reduce how severe symptoms are.

Detoxification programs are generally short-term, inpatient treatment plans used to wean people off of drugs, such as opioids, or alcohol.

Opioid dependence treatment, on the other hand, is a longer-term approach to reducing dependence on opioids, with most of the treatment being done on an outpatient basis.

Suboxone for pain

Suboxone is sometimes used off-label for treating pain. However, this use is controversial, because it’s not clear how well, or if, Suboxone works to treat pain. Suboxone may be beneficial for people who have both chronic pain and opioid dependence.

Buprenorphine, one of the drugs contained in Suboxone, is also used for pain. However, studies of how effective it is for this purpose are mixed.

Suboxone for depression

Suboxone is not used for treating depression. However, buprenorphine, one of the drugs contained in Suboxone, is sometimes used to treat depression and treatment-resistant depression. Some research shows that buprenorphine may improve mood in people with depression.

How Suboxone works

Suboxone contains two ingredients: buprenorphine and naloxone.

Buprenorphine’s role

Buprenorphine has some of the same effects as opioid drugs, but it also blocks other effects of opioids. Because of these unique effects, it’s called an opioid partial agonist-antagonist.

Buprenorphine is the part of Suboxone that helps treat opioid drug dependence. It does this by reducing withdrawal symptoms and drug cravings. And because it’s an opioid partial agonist-antagonist, it’s less likely to cause a high than an opioid.

Naloxone’s role

Naloxone is included in Suboxone solely to help prevent abuse of the medication. Naloxone is classified as an opioid antagonist. This means it blocks the effects of opioid drugs.

If you’re dependent on opioids and inject Suboxone, the naloxone can cause dangerous withdrawal symptoms. This is because it blocks the effects of opioids, putting you into immediate withdrawal.

However, this withdrawal is less likely to occur when you use the Suboxone film. This is because the film releases less naloxone into your body than an injection does.

Phases of treatment

Treatment of opioid dependence occurs in two phases: induction and maintenance. Suboxone is used in both of these phases.

During the induction phase, Suboxone is used to reduce withdrawal symptoms when opioid use is being decreased or stopped. Suboxone is only used for induction in people who are dependent on short-acting opioids. These opioids include heroin, codeine, morphine, and oxycodone (Roxicodone, RoxyBond).

Suboxone should only be used when the effects of these opioids have begun to wear off and withdrawal symptoms have started.

During the maintenance phase, Suboxone is used at a stable dosage for an extended period. The purpose of the maintenance phase is to keep withdrawal symptoms and cravings in check as you go through your drug abuse or addiction treatment program.

After several months to a year or longer, your doctor may stop your Suboxone treatment using a slow dosage taper.