This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Taking Aplenzin may cause you to have suicidal thoughts and behaviors. Your doctor will monitor you for signs of these during your Aplenzin treatment. But if you or a loved one notices that you're thinking about or trying to harm yourself, your doctor should be told right away.

Aplenzin is a brand-name prescription medication. It's used in adults to:

  • Treat major depressive disorder (MDD), a type of depression that can include long-term and very regular feelings of intense sadness.
  • Prevent episodes of depression in people with seasonal affective disorder (SAD), which is a form of MDD. SAD occurs only in certain seasons or times of the year, usually in the winter.

Aplenzin contains the drug bupropion hydrobromide. Aplenzin is a type of medication called an antidepressant and belongs to the aminoketone drug class. A class of drugs is a group of medications that work in a similar way.

Aplenzin comes as an extended-release tablet that you swallow. "Extended-release" means the drug is released more slowly and works longer in the body compared to an immediate-release form.

Effectiveness

There are no clinical trials that have tested the effectiveness of Aplenzin. However, researchers have studied another form of the drug called bupropion hydrochloride. The FDA approved bupropion hydrobromide (Aplenzin) based on these studies because it works in a very similar way to bupropion hydrochloride.

Studies of MDD

In clinical studies of people with MDD, bupropion (the drug in Aplenzin) was found to be more effective than a placebo (no treatment).

A study of MDD looked at people who had taken bupropion hydrochloride sustained-release tablets for 8 weeks. (Sustained-release tablets slowly release the same amount of medication in the body over a period of time.)

The people either continued taking bupropion or stopped taking the drug for up to 44 weeks. The group of people who continued taking bupropion didn't have worsening depression, while those who stopped taking bupropion did. These results were based on whether people needed additional drug treatment due to worsening depression symptoms.

For more information about how effective Aplenzin is in helping treat MDD, see the "Aplenzin uses" section below.

Studies of SAD

In clinical studies of SAD, bupropion hydrochloride extended-release tablets were found to be more effective than a placebo. (With extended-release tablets, the amount of drug released in the body isn't always the same over time.) People who usually had SAD in the winter started taking bupropion in the fall (September to November). They took the drug for about 4 to 6 months. Their dose was lowered until they stopped treatment in early spring (the end of March).

Based on three combined trials, 84.3% of people who took bupropion didn't develop depression compared to 72% of people who took a placebo. These results were based on whether people developed depression symptoms or needed treatment for depression. A depression rating score was used as well.

For more information about how effective Aplenzin is in helping treat SAD, see the "Aplenzin uses" section below.

Aplenzin is available only as a brand-name medication. It's not currently available in generic form.

Aplenzin contains one active drug ingredient: bupropion hydrobromide. But immediate-release and extended-release forms of bupropion hydrochloride are available as generics. Studies have shown that Aplenzin is bioequivalent (clinically similar and works the same) to the generic extended-release bupropion hydrochloride. So if you're interested in a generic, talk with your doctor.

Aplenzin can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Aplenzin. These lists don't include all possible side effects.

For more information on the possible side effects of Aplenzin, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

More common side effects

The more common side effects of Aplenzin can include:

If they're severe or don't go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Aplenzin 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 and their symptoms can include the following:

  • Suicidal thoughts and behaviors.* Symptoms can include:
    • thinking about or trying to harm yourself or others
    • sudden changes in mood, thoughts, behaviors ,or feelings
    • new or worsening depression
    • feeling anxious, irritated, or restless
    • acting angry or violent
    • mania (feeling very energetic or unbeatable)
    • insomnia (trouble sleeping)
    • panic attacks
  • Unusual thoughts or behaviors. Symptoms can include:
    • delusions (believing or thinking you're someone you're not)
    • hallucinations and psychosis (seeing or hearing things that are not there)
    • paranoia (thinking something is going to get you or someone wants to harm you)
    • feeling confused
    • inability to concentrate
  • Seizures. Symptoms can include:
    • jerky body movements that you can't control
    • not being aware of your surroundings
    • loss of consciousness
  • High blood pressure. Symptoms can include:
    • feeling a pounding in your chest
  • Narrow-angle glaucoma (also known as angle-closure glaucoma). Symptoms can include:
    • increased eye pressure

* Aplenzin has a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see "FDA warning" at the beginning of this article.

Suicide prevention

  • If you know someone at immediate risk of self-harm, suicide, or hurting another person:
  • Call 911 or the local emergency number.
  • Stay with the person until professional help arrives.
  • Remove any weapons, medications, or other potentially harmful objects.
  • Listen to the person without judgment.
  • If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide Prevention Lifeline is available 24 hours a day at 1-800-273-8255.

Side effect details

You may wonder how often certain side effects occur with this drug. Here's some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Aplenzin. It's not known how often allergic reactions happen in people using this drug.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Some people have reported having severe allergic and anaphylactic reactions while taking Aplenzin. However, there aren't any clinical studies that found whether Aplenzin causes allergic reactions. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have a severe allergic reaction to Aplenzin. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.

Weight loss

Aplenzin may cause a loss of appetite, which can lead to weight loss.

There aren't any studies of Aplenzin that looked at weight loss. However, researchers have studied bupropion hydrochloride. This drug and bupropion hydrobromide, the main drug in Aplenzin, are bioequivalent (clinically similar and work the same way).

In clinical trials of major depressive disorder (MDD), people took 300-mg or 400-mg bupropion hydrochloride sustained-release tablets each day. (Sustained-release tablets slowly release the same amount of medication in the body over a period of time.) In the 300-mg group, 14% of people lost more than 5 pounds. In the 400-mg group, 19% of people lost more than 5 pounds. This was compared to 6% of people who took a placebo (sugar pill or no active drug in the pill).

In clinical trials for seasonal affective disorder (SAD), people took 150-mg to 300-mg bupropion hydrochloride extended-release tablets each day. (With extended-release tablets, the amount of drug released in the body isn't always the same over time.) In this group, 23% of people lost more than 5 pounds. This was compared to 11% of people who took a placebo.

If you're taking Aplenzin and you lose your appetite for multiple days in a row or lose weight, tell your doctor. They may monitor your weight, have you stop taking Aplenzin, or switch you to another medication.

Insomnia

A type of sleep disorder called insomnia can occur when taking Aplenzin.

There aren't any studies of Aplenzin that looked at insomnia. However, researchers have studied bupropion hydrochloride. This drug and bupropion hydrobromide, the main drug in Aplenzin, work in similar ways.

In clinical trials of major depressive disorder (MDD), people took 300-mg or 400-mg bupropion hydrochloride sustained-release tablets each day. In the 300-mg group, 11% of people developed insomnia. In the 400-mg group, 16% of people developed insomnia. This was compared to 6% of people who took a placebo (no treatment).

In clinical trials for seasonal affective disorder (SAD), people took 150-mg to 300-mg bupropion hydrochloride extended-release tablets each day. In this group, 20% of people developed insomnia. This was compared to 13% of people who took a placebo.

If you have trouble sleeping for multiple days in a row, talk with your doctor. Your doctor may monitor your sleeping patterns, have you stop taking Aplenzin, or switch you to another medication.

Dry mouth

Dry mouth, a condition in which your mouth feels dry, can occur with Aplenzin.

There aren't any studies of Aplenzin that looked at dry mouth. However, researchers have studied bupropion hydrochloride. This drug and bupropion hydrobromide, the main drug in Aplenzin, work in similar ways.

In clinical trials of people with MDD, people took 300-mg or 400-mg bupropion hydrochloride sustained-release tablets each day. In the 300-mg group, 17% of people had dry mouth. In the 400-mg group, 24% of people had dry mouth. This was compared to 7% of people who took a placebo.

In clinical trials of people with SAD, people took 150-mg to 300-mg bupropion hydrochloride extended-release tablets each day. In this group, 26% of people had dry mouth, compared to 15% of people who took a placebo.

If you have dry mouth for multiple days in a row, talk with your doctor. They may monitor your symptoms, have you stop taking Aplenzin, or switch you to another medication.

Nausea

Nausea can occur when taking Aplenzin.

There aren't any studies of Aplenzin that looked at nausea. However, researchers have studied bupropion hydrochloride. This drug and bupropion hydrobromide, the main drug in Aplenzin, work in similar ways.

In clinical trials of MDD, people took 300-mg or 400-mg bupropion hydrochloride sustained-release tablets each day. In the 300-mg group, 13% of people had nausea. In the 400-mg group, 18% of people had nausea. This was compared to 8% of people who took a placebo. Also, 0.8% of people in the 300-mg group and 1.8% in the 400-mg group stopped taking the drug due to nausea. This was compared to 0.3% of people who took a placebo.

In clinical trials of SAD, people took 150-mg to 300-mg bupropion hydrochloride extended-release tablets each day. In this group, 13% of people had nausea, compared to 8% of people who took a placebo.

If you have nausea or have been vomiting for multiple days in a row, talk with your doctor. They may monitor your symptoms, have you stop taking Aplenzin, or switch you to another medication.

Suicidal thoughts and behaviors

Taking Aplenzin may worsen and increase the risk of suicidal thoughts and behaviors.* This risk is highest during the first few months of treatment. An increase in suicidal thoughts or actions is a known risk of depression and other serious psychiatric disorders. This can happen whether or not you are taking an antidepressant medication.

In short-term clinical trials, people with depression and other serious psychiatric disorders took various antidepressants, including bupropion (the main drug in Aplenzin) or a placebo.

The risk of suicidal thoughts and behaviors was highest for people ages 24 years and younger. Out of 1,000 people, compared to those who took a placebo, 14 more people younger than age 18 years and 5 more people between ages 18 and 24 years who took an antidepressant thought of or attempted suicide.

For people ages 25 to 64 years, there was no risk of suicide while taking a placebo.

And finally, there were six fewer cases of suicidal thoughts or suicide attempts in adults ages 65 and older who took an antidepressant. This was compared to people in the same age group who took a placebo.

Your doctor will monitor you for signs of suicidal thoughts and behaviors during your Aplenzin treatment. But if you or a loved one notices that you're thinking about or trying to harm yourself, your doctor should be told right away.

* Aplenzin has a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see "FDA warning" at the beginning of this article.

Other drugs are available that can treat major depressive disorder (MDD) and seasonal affective disorder (SAD). Some may be better suited for you than others. If you're interested in finding an alternative to Aplenzin, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Alternatives for major depressive disorder (MDD)

Examples of other drugs that may be used to treat major depressive disorder (MDD) include:

  • selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine (Prozac)
  • serotonin-norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine (Effexor XR)
  • alpha-2 antagonists, such as mirtazapine (Remeron)
  • tricyclic antidepressants (TCAs), such as nortriptyline (Pamelor)

Monoamine oxidase inhibitors (MAOIs) aren't specifically approved for MDD or SAD, but they can be used to treat depression. Keep in mind that taking Aplenzin with an MAOI can increase your risk for high blood pressure. (To learn more, see the "Aplenzin interactions" section below.)

Alternatives for seasonal affective disorder (SAD)

SAD is a form of MDD, so the same medications can be used to treat both conditions. Please see "Alternatives for major depressive disorder (MDD)" above.

SAD also has some alternative nondrug treatments such as light therapy (for example, special light therapy to use during the winter months to prevent SAD).

You may wonder how Aplenzin compares to other medications that are prescribed for similar uses. Here we look at how Aplenzin and Wellbutrin XL are alike and different.

Uses

The Food and Drug Administration (FDA) has approved both Aplenzin and Wellbutrin XL to treat major depressive disorder (MDD) and prevent episodes of depression in people who have seasonal affective disorder (SAD). MDD is a type of depression that includes long-term and very regular feelings of intense sadness. SAD is a form of MDD, but SAD occurs only in certain seasons or times of the year (usually in the winter).

Drug forms and administration

Both Aplenzin and Wellbutrin XL contain the active drug bupropion. Aplenzin contains bupropion hydrobromide, and Wellbutrin XL contains bupropion hydrochloride. Clinical studies have showed that both forms of bupropion are very similar.

Aplenzin and Wellbutrin XL both come as extended-release tablets that you swallow. "Extended-release" means the drug is released more slowly and works longer in the body compared to an immediate-release form.

Aplenzin is available in three strengths: 174 mg, 348 mg, and 522 mg. Wellbutrin XL is available in two strengths: 150 mg and 300 mg. Both medications are taken once a day in the morning, with or without food.

Side effects and risks

Aplenzin and Wellbutrin XL both contain the drug bupropion. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

This list contains examples of more common side effects that can occur with Aplenzin or Wellbutrin XL (when taken individually):

Serious side effects

This list contains examples of serious side effects that can occur with Aplenzin or Wellbutrin XL (when taken individually):

  • worsening mental health, such as mood changes or thinking of or trying to harm yourself or others*
  • seizures
  • high blood pressure
  • narrow-angle glaucoma (also known as angle-closure glaucoma)
  • allergic reactions

* Aplenzin and Wellbutrin XL have a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see "FDA warning" at the beginning of this article.

Effectiveness

The only conditions both Aplenzin and Wellbutrin XL are used to treat are MDD and SAD.

In clinical studies, Aplenzin (bupropion hydrobromide extended-release) has been shown to be very clinically similar to Wellbutrin XL (bupropion hydrochloride extended-release).

Costs

Aplenzin and Wellbutrin XL are both brand-name drugs. Wellbutrin XL has a generic form, but Aplenzin does not. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Aplenzin is more expensive than Wellbutrin XL and the generic form of Wellbutrin XL. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use.

You may wonder how Aplenzin compares to other medications that are prescribed for similar uses. Here we look at how Aplenzin and Effexor XR are alike and different.

Uses

The Food and Drug Administration (FDA) has approved both Aplenzin and Effexor XR to treat major depressive disorder (MDD). MDD is a type of depression that includes long-term and very regular feelings of intense sadness.

Aplenzin is also approved to prevent depression in people who have seasonal affective disorder (SAD). SAD is a form of MDD, but SAD occurs only in certain seasons or times of the year (usually in the winter). Effexor XR is also approved to treat certain types of anxiety including generalized anxiety disorder, social anxiety disorder (also called social phobia), and panic disorder.

Drug forms and administration

Aplenzin contains the active drug bupropion hydrobromide. Effexor XR contains the active drug venlafaxine.

Aplenzin comes as a tablet that you swallow. You take it once a day in the morning with or without food. Effexor XR comes as a capsule that you can either swallow or open and pour on a spoonful of applesauce. After swallowing the applesauce, you should drink a glass of water. You take Effexor XR once a day (in the morning or evening) with food.

Both Aplenzin and Effexor XR are extended-release. "Extended-release" means the drug is released more slowly and works longer in the body compared to an immediate-release form.

Aplenzin is available in three strengths: 174 mg, 348 mg, and 522 mg. Effexor XR is also available in three strengths: 37.5 mg, 75 mg, and 150 mg.

Side effects and risks

Aplenzin and Effexor XR both contain antidepressant medications. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Aplenzin, with Effexor XR, or with both drugs (when taken individually).

  • Can occur with Aplenzin:
  • Can occur with Effexor XR:
  • Can occur with both Aplenzin and Effexor XR:
    • dry mouth
    • nausea
    • decreased appetite
    • weight loss
    • feeling nervous, anxious, or sweaty

Serious side effects

These lists contain examples of serious side effects that can occur with Aplenzin, with Effexor XR, or with both drugs (when taken individually).

  • Can occur with Aplenzin:
    • few unique serious side effects
  • Can occur with Effexor XR:
  • Can occur with both Aplenzin and Effexor XR:
    • worsening mental health, such as mood changes or thinking of or trying to harm yourself or others*
    • high blood pressure
    • narrow-angle glaucoma (also known as angle-closure glaucoma)
    • seizures
    • allergic reactions

* Aplenzin and Effexor XR have a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see "FDA warning" at the beginning of this article.

Effectiveness

The only condition both Aplenzin and Effexor XR are used to treat is MDD.

These drugs haven't been directly compared in clinical studies, but studies have found both Aplenzin and Effexor XR to be effective for treating MDD.

Costs

Aplenzin and Effexor XR are both brand-name drugs. Effexor XR has a generic form, but Aplenzin does not. Brand-name medications usually cost more than generics.

According to estimates on GoodRx.com, Aplenzin is more expensive than Effexor XR and the generic form of Effexor XR. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use.

Aplenzin dosage

The Aplenzin dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you're using Aplenzin to treat
  • other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they'll slowly adjust it over time to reach the amount that's right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Aplenzin comes as an extended-release tablet that you swallow. "Extended-release" means the drug is released more slowly and works longer in the body compared to an immediate-release form. Aplenzin is available in the following strengths: 174 mg, 348 mg, and 522 mg.

Dosage for major depressive disorder

For major depressive disorder (MDD), your doctor will likely start you on the lowest Aplenzin dose needed. The usual starting dose is 174 mg, once a day in the morning. After taking Aplenzin for 4 days, your doctor will see if your dose needs to be increased. They may slowly increase your dose to 348 mg, once a day. The slow increase is meant to help prevent seizures. (For a list of seizure symptoms, see the "Aplenzin side effects" section above.)

Dosage for seasonal affective disorder

Because seasonal affective disorder (SAD) usually occurs in the winter season, your doctor will probably start your treatment in the fall. This may help prevent episodes of SAD in winter. You'll start taking the lowest dose of Aplenzin needed.

The usual starting dose is 174 mg, once a day. After taking Aplenzin for 1 week, your doctor will see if your dose needs to be increased. They may slowly increase your dose to 348 mg, once a day. The slow increase is meant to help prevent seizures. (For a list of seizure symptoms, see the "Aplenzin side effects" section above.) You'll likely continue treatment through the winter season. Then your doctor will probably start lowering your dose until you stop treatment in early spring.

What if I miss a dose?

If you miss a dose of Aplenzin, wait until it's time for your next scheduled dose. Then keep taking the drug as usual. Don't try to make up the missed dose because taking too much Aplenzin may increase your risk for seizures. (For a list of seizure symptoms, see the "Aplenzin side effects" section above.)

To help make sure that you don't miss a dose, set a reminder on your phone. You can also try using a medication timer.

Will I need to use this drug long term?

Aplenzin is meant to be used as a long-term treatment. If you and your doctor determine that Aplenzin is safe and effective for you, you'll likely take it long term. Your doctor will likely monitor your use of Aplenzin. They may adjust your dose or have you stop treatment if needed.

If you're using Aplenzin for SAD, you may start treatment right before the season you need it for. Then you'll taper off shortly after the season ends.

It's best to avoid drinking alcohol or limit alcoholic drinks while taking Aplenzin because of an increased risk of seizures. In rare cases, Aplenzin strengthened the effect of alcohol, making people more drowsy, and worsened mental health.* Aplenzin shouldn't be used in people who suddenly stop drinking alcohol because this can also increase the risk of seizures.

If you drink alcohol, talk with your doctor before you start taking Aplenzin.

* Aplenzin has a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see "FDA warning" at the beginning of this article.

Aplenzin can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number side effects or make them more severe.

Aplenzin and other medications

Below is a list of medications that can interact with Aplenzin. This list doesn't contain all drugs that may interact with Aplenzin.

Before taking Aplenzin, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Aplenzin and CYP2B6 inducers

Taking Aplenzin with certain drugs called CYP2B6 inducers can decrease the level of Aplenzin in your body.

Examples of CYP2B6 inducers include:

  • HIV drugs such as ritonavir (Norvir), lopinavir/ritonavir (Kaletra), and efavirenz (Sustiva)
  • seizure drugs such as carbamazepine (Tegretol), phenytoin (Dilantin), and phenobarbital

Before you take Aplenzin, tell your doctor if you're using any of these drugs. They may monitor you during your Aplenzin treatment or increase your Aplenzin dose, if you're not already taking the maximum dose each day. Or your doctor may switch you to a different medication.

Aplenzin and CYP2B6 inhibitors

Taking Aplenzin with certain drugs called CYP2B6 inhibitors can increase the level of Aplenzin in your body.

Examples of CYP2B6 inhibitors include:

  • blood-thinning drugs such as ticlopidine (Ticlid), clopidogrel (Plavix), and prasugrel (Effient)

Before you take Aplenzin, tell your doctor if you're using any of these drugs. They may monitor you during your Aplenzin treatment or adjust your Aplenzin dose. Or your doctor may switch you to a different medication.

Aplenzin and drugs broken down by the CYP2D6 enzyme

Aplenzin blocks an enzyme called CYP2D6. (An enzyme is a type of protein.) This enzyme breaks down certain drugs in your body. Taking Aplenzin with drugs that CYP2D6 breaks down can increase the levels of those drugs in your body.

Examples of these drugs include:

Before you take Aplenzin, tell your doctor if you're using any of these drugs. They may monitor you during your Aplenzin treatment, lower the dose of your other medication, or switch you to a different medication.

Aplenzin and drugs that can increase your risk of seizures

Taking Aplenzin may increase your risk for seizures. Other drugs may also increase your risk for seizures. So taking Aplenzin with these drugs may increase your seizure risk even more.

Examples of drugs that can increase your risk for seizures:

  • other drugs that contain bupropion (the active drug in Aplenzin), such as Wellbutrin XL or Wellbutrin SR

Before you take Aplenzin, tell your doctor if you're using a drug that raises your risk of seizures. They may monitor you during your Aplenzin treatment, keep you on a lower dose of Aplenzin, or switch you to a different medication.

Aplenzin and dopaminergic drugs

Drugs called dopaminergics affect a chemical in your body called dopamine. Taking Aplenzin with dopaminergic drugs can cause dopamine to build up to dangerous levels. This can affect your central nervous system, which includes your brain and spinal cord. You may feel dizzy, shaky, nervous, or have trouble walking.

Examples of dopaminergic drugs are those for Parkinson's disease such as levodopa (Inbrija) and amantadine (Gocovri, Osmolex ER).

Before you take Aplenzin, tell your doctor if you're using any of these drugs. They may monitor you during your Aplenzin treatment, change your dose, or switch you to a different medication.

Aplenzin and drugs that can increase blood pressure

Taking Aplenzin can increase your blood pressure. Other drugs can also increase your blood pressure. So taking Aplenzin with these drugs can increase your risk for high blood pressure.

Examples of drugs that can increase your blood pressure include:

  • monoamine oxidase inhibitors (MAOIs) such as phenelzine (Nardil), which treat depression
  • linezolid (Zyvox), an antibiotic
  • methylene blue (ProvayBlue), a drug that's used treat a blood disorder called methemoglobinemia

Your doctor will likely have you stop taking the MAOI at least 14 days before you start using Aplenzin. In some situations, they may want you to take an MAOI while you're taking Aplenzin. If this is the case, your doctor will have you stop using Aplenzin 14 days before you start taking an MAOI. You shouldn't use Aplenzin if you're taking linezolid or methylene blue.

Aplenzin and certain laboratory tests

Aplenzin may cause a false positive result in urine tests for amphetamines, even if you've stopped taking Aplenzin. (Amphetamines are a type of medication that's often used to treat attention deficit hyperactivity disorder [ADHD].) Your doctor may order a different test to check for amphetamine use.

Aplenzin and herbs and supplements

There aren't any herbs or supplements that have been specifically reported to interact with Aplenzin. However, you should still check with your doctor or pharmacist before using any of these products while taking Aplenzin. It's possible that some herbs or supplements can increase your risk of seizures while you're taking Aplenzin.

The Food and Drug Administration (FDA) approves prescription drugs such as Aplenzin to treat certain conditions. Aplenzin may also be used off-label for other conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.

Aplenzin for major depressive disorder

Aplenzin is used to treat major depressive disorder (MDD). MDD is a type of depression that includes long-term and very regular feelings of intense sadness. Someone with MDD may feel hopeless, lose interest in activities they once enjoyed, or feel as though life isn't worth living. These feelings last over a long period of time.

Effectiveness

Aplenzin is an extended-release drug that contains bupropion hydrobromide. There are no clinical trials that tested the effectiveness of Aplenzin. However, researchers have studied another form of the drug called bupropion hydrochloride. The FDA approved bupropion hydrobromide based on these studies because it works in a very similar way to bupropion hydrochloride.

In clinical studies of MDD, the immediate-release form of bupropion hydrochloride was found to be more effective than a placebo (no treatment).

In three short-term studies that lasted 4 to 6 weeks, people took bupropion hydrochloride immediate-release tablets or a placebo. Based on different depression rating scales, bupropion was more effective at treating MDD compared to the placebo. Depending on the study, these scales included the:

  • Hamilton Depression Rating Scale
  • Clinical Global Impressions-Severity Scale
  • Montgomery-Asberg Depression Rating Scale

A longer study of MDD looked at people who had taken bupropion hydrochloride sustained-release tablets for 8 weeks. (Sustained-release tablets slowly release a steady amount of medication in the body over a long period of time.) The people either continued taking bupropion or stopped taking the drug for up to 44 weeks. The group of people who continued taking bupropion didn't have worsening depression, while those who stopped taking bupropion did. These results were based whether people needed additional drug treatment due to worsening depression symptoms.

Aplenzin for seasonal affective disorder

Aplenzin is used to prevent episodes of depression in people who have seasonal affective disorder (SAD). SAD is a form of MDD but happens only in certain seasons or times of the year (usually in the winter).

Effectiveness

Aplenzin is an extended-release drug that contains bupropion hydrobromide. There are no clinical trials that tested the effectiveness of Aplenzin. However, researchers have studied another form of the drug called bupropion hydrochloride. Bupropion hydrochloride comes in immediate-, sustained-, and extended-release versions. All these versions and Aplenzin work in a similar way in the body.

In clinical studies of SAD, bupropion hydrochloride extended-release tablets were found to be more effective than a placebo (no treatment). People with SAD in the winter started taking bupropion in the fall (September to November). They took the drug for about 4 to 6 months and started to lower their dose until they stopped treatment in early spring (the end of March).

Based on three combined trials, 84.3% of people who took bupropion didn't develop depression compared to 72% of people who took a placebo. These results were based on whether people developed depression symptoms or needed treatment for depression, and a depression rating score. The score was determined by the Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders.

Off-label uses for Aplenzin

In addition to the uses listed above, Aplenzin may be used off-label. Off-label drug use is when a drug that's approved for one use is used for a different one that's not approved.

Aplenzin for ADHD

Aplenzin isn't FDA-approved to treat the mental health condition called attention deficit hyperactivity disorder (ADHD). However, Aplenzin may be prescribed off-label to treat ADHD.

A review of six clinical studies found that bupropion (the active drug in Aplenzin) helped decrease ADHD symptoms in adults more than a placebo (no treatment).

Aplenzin for sexual dysfunction

Aplenzin isn't FDA-approved to treat sexual dysfunction, which includes trouble getting an erection or achieving orgasm.

However, American Psychiatric Association guidelines recommend using bupropion (the active drug in Aplenzin) off-label to treat sexual dysfunction when it's a side effect of a selective serotonin reuptake inhibitor (SSRI) medication. (SSRIs are a type of antidepressant that can cause sexual dysfunction.) The guidelines specify Aplenzin's use for people with MDD who are taking SSRIs such as sertraline (Zoloft).

Aplenzin for children

Aplenzin is approved for use in adults only. Aplenzin hasn't been proven to be safe and effective in children.

In short-term clinical trials, people took various antidepressants, including bupropion (the main drug in Aplenzin). The risk of suicidal thoughts and behaviors* was highest for people ages 24 years and younger. Out of 1,000 people, compared to those who took a placebo, 14 more people younger than age 18 years and 5 more people between ages 18 and 24 years who took an antidepressant thought of or attempted suicide.

* Aplenzin has a boxed warning for suicidal thoughts and behaviors. This is the most serious warning from the Food and Drug Administration (FDA). For more information, see "FDA warning" at the beginning of this article.

As with all medications, the cost of Aplenzin can vary. To find current prices for Aplenzin in your area, check out GoodRx.com:

The cost you find on GoodRx.com is what you may pay without insurance. The actual price you'll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial assistance

If you need financial support to pay for Aplenzin, help is available. Valeant Pharmaceuticals North America LLC, the manufacturer of Aplenzin, offers a Copay Savings Program. For more information and to find out if you're eligible for support, call 844-556-3476 or visit the program website.

You should take Aplenzin according to your doctor or healthcare provider's instructions.

When to take

Aplenzin comes as a tablet that you take once a day by swallowing it. You can take the medication with or without food in the morning. Make sure the doses are at least 8 hours apart.

If you miss an Aplenzin dose, wait until it's time for your next scheduled dose. Then keep taking the drug as usual. Don't try to make up the missed dose because taking too much Aplenzin may increase your risk for seizures. (For a list of seizure symptoms, see the "Aplenzin side effects" section above.)

To help make sure that you don't miss a dose, set a reminder on your phone. You can also try using a medication timer.

Taking Aplenzin with food

You can take Aplenzin with or without food because food doesn't affect how well the medication works.

Can Aplenzin be crushed, split, or chewed?

No, you shouldn't crush, split, or chew Aplenzin. Doing so can cause your body to absorb the drug too quickly and lead to side effects. (See the "Aplenzin side effects" section above.) Be sure to swallow the Aplenzin tablet whole with a liquid such as water.

A possible cause of depression, such as MDD and SAD, is a chemical imbalance in the brain. Some chemicals in the brain that impact mood are dopamine and norepinephrine.

Aplenzin belongs to a drug class called antidepressants. (A class of drugs is a group of medications that work in a similar way.) The way that Aplenzin works isn't completely understood. But it's thought that the drug blocks neurons (nerve cells) from absorbing chemicals called dopamine and norepinephrine. As a result, there are more of these chemicals in the brain, so this helps correct the chemical imbalance.

How long does it take to work?

Aplenzin should start working about a week after you start taking it. It takes 8 days to reach a stable level in your body.

There isn't enough data to know if it's safe to take Aplenzin while pregnant. In clinical studies, pregnant mothers took bupropion, the active drug in Aplenzin, in the first 3 months of pregnancy. Bupropion didn't increase the risk of birth defects such as heart problems. However, more data is needed to confirm whether or not Aplenzin is safe to take during pregnancy.

Some animal studies found that bupropion given to pregnant mothers didn't harm the babies. But other animal studies found that the drug did harm the babies. Keep in mind that animal studies don't always predict what will happen in humans.

If you're pregnant or are planning to become pregnant, talk with your doctor. They can tell you about the pros and cons of using Aplenzin while pregnant compared to the risks of untreated depression.

It's not known if Aplenzin is safe to take during pregnancy. If you or your sexual partner can become pregnant, talk with your doctor about your birth control needs while you're using Aplenzin.

There isn't enough data to know if it's safe to take Aplenzin while breastfeeding. However, in clinical studies, Aplenzin did pass into breast milk.

If you're breastfeeding or are planning to breastfeed, talk with your doctor. They can tell you about the pros and cons of using Aplenzin while breastfeeding compared to the risks of untreated depression.

Here are answers to some frequently asked questions about Aplenzin.

Can Aplenzin make me gain weight?

Taking Aplenzin shouldn't make you gain weight. In fact, the drug may actually cause you to lose weight. (For more on Aplenzin and weight loss, see "Weight loss" in the "Side effect details" section above.)

There aren't any studies of Aplenzin that looked at weight gain. However, researchers have studied bupropion hydrochloride. This drug and bupropion hydrobromide, the main drug in Aplenzin, work in similar ways.

In clinical trials of major depressive disorder (MDD), people took 300-mg or 400-mg bupropion hydrochloride sustained-release tablets each day. (Sustained-release tablets slowly release the same amount of medication in the body over a period of time.) In the 300-mg group, 3% of people gained more than 5 pounds. In the 400-mg group, 2% of people gained more than 5 pounds. This was compared to 4% of people who took a placebo (no treatment).

In clinical trials of seasonal affective disorder (SAD), people took 150-mg to 300-mg bupropion hydrochloride extended-release tablets each day. (With extended-release tablets, the amount of drug released in the body isn't always the same over time.) In this group, 11% of people gained more than 5 pounds. This was compared to 21% of people who took a placebo.

If you're concerned about weight gain, talk with your doctor. They can review your diet and exercise routine.

Can Aplenzin cause sexual problems?

Aplenzin hasn't been shown to cause sexual problems. However, other antidepressants such as sertraline (Zoloft) may cause sexual problems such as trouble getting an erection, difficulty achieving orgasm, or a lower sex drive.

If you're concerned about sexual problems, talk with your doctor.

Can I take Aplenzin if I have an eating disorder?

No. You shouldn't take Aplenzin if you have or have had an eating disorder such as anorexia or bulimia. This is because Aplenzin can make these disorders worse and increase your risk for seizures. (For a list of seizure symptoms, see the "Aplenzin side effects" section above.)

If you have a history of eating disorders, talk with your doctor. They may be able to suggest a depression treatment other than Aplenzin.

I've noticed what looks like a pill in my stool. Does this mean I didn't get my full dose of Aplenzin?

You received your proper dose. After taking Aplenzin, only a very small amount (0.5%) of the drug may be left in your stool. Your body absorbs the rest of the medication to help treat MDD or SAD.

This drug comes with several precautions.

FDA warning: Suicidal thoughts and behaviors

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Taking Aplenzin may cause you to have suicidal thoughts and behaviors. Your doctor will monitor you for signs of these during your Aplenzin treatment. But if you or a loved one notices that you're thinking about or trying to harm yourself, your doctor should be told right away.

Other precautions

Before taking Aplenzin, talk with your doctor about your health history. Aplenzin may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Allergic reactions. If you've had an allergic reaction to bupropion or any other ingredients in Aplenzin, your doctor may switch you to another medication. Or they may monitor your Aplenzin treatment, depending on how severe the allergic reaction was.
  • Alcohol use. Drinking alcohol or suddenly stopping drinking alcohol while taking Aplenzin may increase your risk for seizures. To learn more, please see the "Aplenzin and alcohol" section above.
  • Seizures. If you have seizures or had them in the past, you shouldn't take Aplenzin. The medication may increase your risk for seizures. Ask your doctor what other depression treatments may better suited for you.
  • High blood pressure. If you have high blood pressure, taking Aplenzin may make it even higher. (Please see the "Aplenzin interactions" section above.) Your doctor will likely monitor your blood pressure while you're taking Aplenzin.
  • Bipolar disorder. Taking Aplenzin when you have a mental illness called bipolar disorder can lead to mania (feeling very energetic or unbeatable). While you take Aplenzin, your doctor may monitor you for symptoms of bipolar disorder or switch you to another medication.
  • Psychosis and worsening mental health. Aplenzin may cause symptoms of psychosis such seeing or thinking about things that aren't there. This includes having hallucinations, delusions, or paranoia. If you have worsening mental health while taking Aplenzin, tell your doctor. They may lower your dose or switch you to a different medication.
  • Anorexia or bulimia. If you have or have had an eating disorder such anorexia or bulimia, you shouldn't take Aplenzin. This is because the drug can cause more weight loss and increase your risk for seizures. Ask your doctor what other depression treatments may be better suited for you.
  • Narrow-angle glaucoma. Aplenzin may increase pressure in your eyes, which can lead to new or worsening narrow-angle glaucoma. This kind of glaucoma is also known as angle-closure glaucoma.If you have this form of glaucoma, your doctor will monitor you while you take Aplenzin.
  • Pregnancy and breastfeeding. It's not known if Aplenzin is harmful during pregnancy and breastfeeding. Your doctor can advise you on the risks of taking Aplenzin compared to the risks of untreated depression. For more information, please see the "Aplenzin and pregnancy" and "Aplenzin and breastfeeding" sections above.

Note: For more information about the potential negative effects of Aplenzin, see the "Aplenzin side effects" section above.

Taking more than the recommended dose of Aplenzin can lead to serious side effects, including increasing your risk for seizures. When you have a seizure, the electrical activity in your brain changes. You may have jerky body movements that you can't control, not be aware of your surroundings, or lose consciousness. Seizures have been reported in one-third of overdose cases.

Overdose symptoms

Symptoms of an overdose can include:

  • seizures
  • hallucinations (seeing things that aren't really there)
  • feeling fast, uneven, or skipped heartbeats
  • low blood pressure, which may make you feel lightheaded or dizzy
  • fever
  • stiffness or pain in your muscles
  • coma or your body shuts down (for example, you stop breathing)

What to do in case of overdose

If you think you've taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Aplenzin from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Store Aplenzin tablets at room temperature (77°F/25°C) in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as in bathrooms.

Disposal

If you no longer need to take Aplenzin and have leftover medication, it's important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Aplenzin (bupropion hydrobromide extended-release) is used to treat adults with major depressive disorder (MDD) and used to prevent depression in adults who have seasonal affective disorder (SAD).

Mechanism of action

Aplenzin is an antidepressant that belongs to the aminoketone drug class. The mechanism of action is unknown, but the drug is thought to block neurons from absorbing dopamine and norepinephrine.

Pharmacokinetics and metabolism

Aplenzin 348 mg given once daily should reach steady-state within 8 days. The half-life of bupropion is 21.3 hours.

After taking Aplenzin, it takes 6 hours for the active metabolites of bupropion (hydroxybupropion, erythrohydrobupropion, and threohydrobupropion) to reach peak plasma levels. The half-life of hydroxybupropion is 24.3 hours, the half-life of erythrohydrobupropion is 31.1 hours, and the half-life of threohydrobupropion is 50.8 hours.

While there are no direct trials with Aplenzin (extended-release version), immediate-release, sustained-release, and extended-release forms of bupropion have similar bioavailability. Also, Aplenzin (bupropion hydrobromide extended-release) is bioequivalent to bupropion hydrochloride extended-release.

Contraindications

Aplenzin is contraindicated in patients who:

  • have a seizure history
  • have anorexia or bulimia either currently or had it in the past
  • have suddenly stopped drinking alcohol or taking benzodiazepines, antiepileptics, or barbiturates
  • are taking or have taken monoamine oxidase inhibitors (MAOIs) in the past 14 days or are taking linezolid (Zyvox) or methylene blue (ProvayBlue)
  • have experienced hypersensitivity reactions to bupropion or any other ingredients in Aplenzin

Misuse and dependence

In human and animal studies, bupropion immediate-release showed some mild effects similar to amphetamines compared to placebo. Bupropion immediate-release was not tested at higher doses due to risk of seizures. There have been reports of seizures and death when crushed bupropion tablets were used parenterally or intranasally. However, there isn't enough evidence to know the abuse potential of Aplenzin or bupropion.

Storage

Aplenzin should be stored at 77°F (25°C), but excursions from 59°F to 86°F (15°C to 30°C) are acceptable.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.