Zulresso (brexanolone)

FDA warning: Severe sedation and loss of consciousness

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

Zulresso can cause severe sedation, with symptoms such as sleepiness, trouble thinking clearly, and not being able to drive. It can also cause loss of consciousness (not being able to respond to noise or touch).

Your doctor will monitor you while you receive the Zulresso infusion because of this risk. They will also be present if you are with your child (or children) in case you lose consciousness.

Due to the risk of loss of consciousness, Zulresso is only prescribed and given at certified healthcare facilities.

What is Zulresso?

Zulresso is a brand-name prescription medication that’s prescribed for postpartum depression (PPD) in adults. PPD is depression that typically starts within a few weeks of giving birth. For some, it doesn’t start until months after having a baby.

Zulresso does not cure PPD, but it can help relieve PPD symptoms. These can include feeling extremely sad, anxious, and overwhelmed. PPD may prevent you from being able to care for your baby, and it can have serious negative effects on you and your family.

Zulresso contains the drug brexanolone. It’s given as an intravenous (IV) infusion, which goes into your vein. You’ll receive the infusion over a period of 60 hours (2.5 days). You will stay in a specially certified healthcare facility while you receive Zulresso. (At this time, it’s not known if more than one treatment with Zulresso is safe or effective.)

Effectiveness

In clinical studies, Zulresso relieved symptoms of PPD more than a placebo (a treatment without an active drug). The studies used a depression severity scale with a maximum score of 52 points. According to the studies, moderate PPD is diagnosed with a score of 20 to 25 points. Severe PPD is diagnosed with a score of 26 points or higher.

One study included women with severe PPD. After the 60-hour Zulresso infusion, depression scores for these women were improved by 3.7 to 5.5 more points than the scores of women taking a placebo.

In a study that included women with moderate PPD, Zulresso improved depression scores by 2.5 more points than a placebo after the 60-hour infusion.

FDA approval

Zulresso was approved by the Food and Drug Administration (FDA) in March 2019. It’s the first and only drug the FDA has approved to specifically treat PPD. However, it’s not yet available for use (see “Is Zulresso a controlled substance?” below).

Is Zulresso a controlled substance?

Yes, Zulresso is a controlled substance, which means its use is closely monitored by the federal government. Each controlled substance is assigned a schedule based on its medical use, if any, and its potential for misuse. Zulresso is classified as a schedule 4 (IV) drug.

Zulresso is expected to be available in late June 2019.

The government has created special rules for how each category of scheduled drugs can be prescribed and dispensed. Your doctor and pharmacist can tell you more about these rules.

Zulresso generic

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

Zulresso contains the active drug ingredient brexanolone.

Zulresso cost

As with all medications, the cost of Zulresso can vary. Sage Therapeutics, the manufacturer of Zulresso, says in its quarterly report that the list price is $7,450 for one vial. Treatment requires an average of 4.5 vials, so the total cost would be about $34,000 before discounts. The actual price you’ll pay depends on your insurance plan.

Financial and insurance assistance

If you need financial support to pay for Zulresso, help is on the way. Sage Therapeutics, the manufacturer of Zulresso, has announced that they will offer financial assistance programs for women who qualify.

For more information, contact Sage Therapeutics at 617-299-8380. You can also check for updated information at the company’s website.

Zulresso side effects

Zulresso can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Zulresso. These lists do not include all possible side effects.

For more information on the possible side effects of Zulresso, 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 Zulresso can include:

• sedation (sleepiness, trouble thinking clearly, not being able to drive or use heavy machinery)
• dizziness or vertigo (feeling like you’re moving when you’re not)
• feeling like you’re going to faint
• dry mouth
• skin flushing (redness and a feeling of warmth in your skin)

Most 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 with your doctor or pharmacist.

Serious side effects

Serious side effects from Zulresso can occur. Call your doctor right away if you have serious side effects after you leave the healthcare facility where you received your dose. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

• Loss of consciousness. Symptoms can include:
  • fainting
  • not being able to respond to sound or touch
  • appearing to be asleep
• Severe sedation. Symptoms can include:
  • sleepiness
  • trouble thinking clearly
  • not being able to drive or use heavy machinery
• Suicidal thoughts and behaviors in young adults (younger than 25 years old).* Symptoms can include:
  • talking about feeling hopeless, alone, or trapped
  • worsening of depression
  • talking about self-harm, death, or suicide
  • attempting self-harm
• Severe allergic reaction (see “Side effect details” below)

*These effects can also occur in children. This drug is not approved for use in children.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on certain side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Zulresso. 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. Symptoms of a severe allergic reaction can include:

• angioedema (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 Zulresso after you leave the healthcare facility. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Sedation and loss of consciousness

Sedation is a common side effect with Zulresso. Symptoms include sleepiness and trouble thinking clearly. In certain cases, sedation may be severe, leading to extreme sleepiness and even loss of consciousness.

In clinical studies, 5% of people had severe sedation that required a temporary stop or change in treatment. In people taking a placebo (a treatment with no active medication), none had the same effect.

Loss of consciousness means fainting or appearing to be asleep. During this time, you are unable to respond to sound or touch. In the clinical studies, 4% of people who took Zulresso lost consciousness. None of the people who took a placebo had this effect.

For each person who lost consciousness in the studies, the treatment was stopped. Each of these people regained consciousness about 15 to 60 minutes after stopping the treatment.

When you receive Zulresso, your doctor will monitor you for loss of consciousness. They’ll do this every two hours during non-sleeping times. (You’ll follow a normal sleep schedule during your treatment.)

Both severe sedation and loss of consciousness can lead to low oxygen levels (hypoxia). If you become sedated or lose consciousness, your breathing may become slower. When this happens, your body takes in less oxygen. Too little oxygen in your cells and tissues can cause damage to your brain, liver, and other organs.

For this reason, your doctor will monitor the oxygen levels in your blood throughout your treatment. If you lose consciousness or have low oxygen levels in your blood, your doctor will stop the Zulresso treatment temporarily. If they decide to restart the Zulresso treatment, they may use a lower dose.

Because of the risk for loss of consciousness, Zulresso is only given by healthcare professionals who are certified to give this treatment.

Zulresso for postpartum depression

The Food and Drug Administration (FDA) approves prescription drugs such as Zulresso to treat certain conditions.

Zulresso is FDA-approved to treat adults with postpartum depression (PPD). This condition is a serious form of major depression that occurs within weeks to months of giving birth. It’s more severe than the “baby blues” many women have shortly after delivery. Untreated PPD can make a mother less able to care for her baby.

PPD may be caused by several factors, including:

• changes in your hormone levels
• fatigue (lack of energy)
• poor or irregular diet
• changes in your social or professional life (like staying home more than you used to)
• poor or irregular sleep schedule
• feeling isolated

Symptoms of postpartum depression can include:

• exhaustion
• anxiety
• severe mood swings
• feeling like you’re a “bad mother”
• trouble sleeping or eating
• fears about hurting yourself or others
• suicidal thoughts or behaviors

In clinical studies, Zulresso relieved symptoms of PPD more than a placebo (a treatment without an active drug). The studies used a rating scale to measure how severe each person’s depression was before and after being given Zulresso. The rating scale has a maximum score of 52 points, with higher scores suggesting more serious depression. According to the studies, moderate PPD is diagnosed with a score of 20 to 25 points. Severe PPD is diagnosed with a score of 26 points or higher.

One study included women with severe PPD. After the 60-hour Zulresso infusion, depression scores for these women were improved by 3.7 to 5.5 more points than the scores of women taking a placebo. In a study that included women with moderate PPD, Zulresso improved depression scores by 2.5 more points than a placebo after the 60-hour infusion.

Zulresso dosage

The Zulresso dosage your doctor prescribes will depend on how your body responds to Zulresso.

Your doctor will start you on a low dose and increase it over several hours. They’ll adjust it over time to reach the amount that your body tolerates without serious side effects. In the last few hours of the treatment, they’ll lower the dose again.

The following information describes commonly used or recommended dosages. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Zulresso comes as a solution that’s given as an intravenous (IV) infusion, which goes into your vein. You’ll receive the infusion over a period of 60 hours (2.5 days). You will stay in a healthcare facility for the entire infusion.

Dosage for postpartum depression (PPD)

Your doctor will determine your dosage based on your weight. A kilogram (kg) equals about 2.2 pounds.

The recommended dosage of Zulresso for PPD is:

• Start of infusion through hour 3: 30 mcg/kg per hour
• Hours 4–23: 60 mcg/kg per hour
• Hours 24–51: 90 mcg/kg per hour
• Hours 52–55: 60 mcg/kg per hour
• Hours 56–60: 30 mcg/kg per hour

If you have serious side effects during the infusion, your doctor may interrupt the treatment or decrease the dosage of Zulresso. They will restart the treatment or maintain the dosage if they decide it’s safe for you to continue receiving Zulresso.

Will I need to use this drug long term?

Zulresso is not meant to be used as a long-term treatment. After you receive Zulresso, you and your doctor can discuss safe and effective antidepressant treatments that you can take long term if needed.

Zulresso and alcohol

You should not drink alcohol immediately before or during your Zulresso treatment. Alcohol can increase the risk of severe sedation (sleepiness, trouble thinking clearly) if consumed with Zulresso. It can also increase the risk of loss of consciousness (not being able to respond to sound or touch).

If you’re concerned about being able to avoid alcohol near the time of your treatment, talk with your doctor. You can also talk about whether drinking alcohol is safe for you after your treatment.

Zulresso interactions

Zulresso can interact with several other medications.

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

Zulresso and other medications

Below is a list of medications that can interact with Zulresso. This list does not contain all drugs that may interact with Zulresso.

Before taking Zulresso, 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.

Zulresso and opioids

Taking pain medications such as opioids before or during Zulresso treatment can increase the risk of serious side effects. Taking Zulresso with opioids can increase the risk of severe sedation (sleepiness, trouble thinking clearly, and not being able to drive or use heavy machinery). It can also increase your risk of loss of consciousness (not being able to respond to sound or touch).

Examples of opioids that can increase the risk of sedation and loss of consciousness if taken with Zulresso include:

• hydrocodone (Hysingla, Zohydro)
• oxycodone (Oxycontin, Roxicodone, Xtampza ER)
• codeine
• morphine (Kadian, MS Contin)
• fentanyl (Abstral, Actiq, Duragesic, others)
• methadone (Dolophine, Methadose)

Many pain medications contain a combination of opioids and other drugs. Be sure to tell your doctor about all medications you take. If you’re taking a pain medication, they may recommend that you not take it immediately before and during Zulresso treatment. This will help reduce the risk of severe sedation and loss of consciousness.

Zulresso and certain anxiety medications

Taking Zulresso with benzodiazepines (medications used to treat anxiety) can increase the risk of serious side effects. Taking Zulresso with a benzodiazepine can increase the risk of severe sedation (sleepiness, trouble thinking clearly, not being able to drive or use heavy machinery). It can also increase your risk for loss of consciousness (not being able to respond to sound or touch).

Examples of benzodiazepines that can increase the risk of sedation and loss of consciousness if taken with Zulresso include:

• alprazolam (Xanax, Xanax XR)
• diazepam (Valium)
• lorazepam (Ativan)
• temazepam (Restoril)
• triazolam (Halcion)

Zulresso and certain sleep medications

Taking Zulresso with certain medications for insomnia (trouble sleeping) can increase the risk of severe sedation. Symptoms of sedation can include sleepiness, trouble thinking clearly, and not being able to drive or use heavy machinery. They can also include loss of consciousness (not being able to respond to sound or touch).

Examples of insomnia medications that can increase the risk of sedation and loss of consciousness if taken with Zulresso include:

• eszopiclone (Lunesta)
• zaleplon (Sonata)
• zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist)

Zulresso and antidepressants

Taking Zulresso with other antidepressant medications can increase the risk of serious side effects, such as severe sedation (sleepiness, trouble thinking clearly, not being able to drive or use heavy machinery. It can also cause loss of consciousness (not being able to respond to sound or touch).

Examples of antidepressants that can increase the risk of sedation and loss of consciousness include:

• fluoxetine (Prozac, Sarafem, Selfemra)
• sertraline (Zoloft)
• citalopram (Celexa)
• escitalopram (Lexapro)
• paroxetine (Brisdelle, Paxil, Pexeva)
• venlafaxine (Effexor XR)
• duloxetine (Cymbalta)

Alternatives to Zulresso

Other drugs used for depression can help treat postpartum depression (PPD). Each of these alternative drugs is used off-label to treat PPD. Off-label use is when a drug that’s approved for one use is prescribed for another use.

Some of these drugs may be better suited for you than others. If you’re interested in finding an alternative to Zulresso, talk with your doctor. They can tell you about other medications that may work well for you.

Examples of other drugs that may be used off-label to treat PPD include:

• fluoxetine (Prozac, Sarafem, Selfemra)
• paroxetine (Brisdelle, Paxil, Pexeva)
• sertraline (Zoloft)
• nortriptyline (Pamelor)
• amitriptyline
• bupropion (Wellbutrin SR, Wellbutrin XL, Zyban)
• esketamine (Spravato)

Zulresso vs. Zoloft

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

Uses

Zulresso and Zoloft are approved by the Food and Drug Administration (FDA) to treat different conditions.

Zulresso is FDA-approved to treat postpartum depression (PPD) in adults.

Zoloft is FDA-approved to treat adults with the following conditions:

Zoloft is also approved to treat people ages 6 years and older with obsessive-compulsive disorder. Zoloft is used off-label to treat PPD.

Zulresso contains the drug brexanolone. Zoloft contains the drug sertraline.

Drug forms and administration

Zulresso comes as a solution that’s given as an intravenous (IV) infusion, which goes into your vein. You’ll receive the infusion in a healthcare facility over a period of 60 hours (2.5 days).

Zoloft comes as a tablet or a solution that’s taken by mouth. It’s taken once per day.

Side effects and risks

Zulresso and Zoloft contain different drugs. Therefore, the medications can cause very different 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 Zulresso and with Zoloft.

• Can occur with Zulresso:
• sedation (sleepiness, trouble thinking clearly, not being able to drive or use heavy machinery)
• dizziness or vertigo (feeling like you’re moving when you’re not)
• feeling like you’re going to faint
• dry mouth
• skin flushing (redness and warm feeling in skin)
• Can occur with Zoloft:
• nausea
• diarrhea or loose stools
• upset stomach
• loss of appetite
• excessive sweating
• tremor (uncontrollable movement of parts of your body)
• inability to ejaculate
• decreased libido (little or no sex drive)

Serious side effects

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

• Can occur with Zulresso:
• severe sedation
• loss of consciousness (not being able to respond to sound or touch)
• Can occur with Zoloft:
• serotonin syndrome (too much serotonin in the body)
• increased risk of bleeding
• hyponatremia (low sodium levels)
• abnormal heart rhythm
• withdrawal due to stopping Zoloft
• angle-closure glaucoma (increased pressure in your eye)
• Can occur with both Zulresso and Zoloft:
• suicidal thoughts and behaviors in young adults (younger than 25 years old)

Effectiveness

Zulresso and Zoloft have different FDA-approved uses, but they’re both used to treat PPD. This is an off-label use for Zoloft. Don’t use Zoloft to treat PPD without talking with your doctor first.

These drugs haven’t been directly compared in clinical studies, but studies have found Zulresso to be effective for treating PPD.

A review of several clinical studies found that Zoloft was effective in treating PPD in some studies but not in others.

Costs

Zulresso and Zoloft are both brand-name drugs. There are currently no generic forms of Zulresso, but there is a generic form of Zoloft called sertraline. Brand-name medications usually cost more than generics.

The list price of Zulresso is a total of about $34,000 for the infusion before discounts, according to the manufacturer’s quarterly report. Based on that price and the estimated price of Zoloft from GoodRx, Zulresso is much more expensive. The actual price you’ll pay for either drug will depend on your insurance plan.

Zulresso vs. Lexapro

Zulresso and Lexapro are prescribed for similar uses. Below are details of how these medications are alike and different.

Uses

Zulresso and Lexapro are approved by the Food and Drug Administration (FDA) to treat different conditions.

Zulresso is approved to treat postpartum depression (PPD) in adults.

Lexapro is approved to treat major depressive disorder in people ages 12 years and older. It’s also approved to treat generalized anxiety disorder in adults. Lexapro is used off-label to treat PPD.

Zulresso contains the drug brexanolone. Lexapro contains the drug escitalopram.

Drug forms and administration

Zulresso comes as a solution that’s given as an intravenous (IV) infusion, which goes into your vein. You’ll receive the infusion in a healthcare facility over a period of 60 hours (2.5 days).

Lexapro comes as a tablet and a solution. Either form is taken by mouth once daily.

Side effects and risks

Zulresso and Lexapro contain different drugs. Therefore, they can cause very different 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 Zulresso, with Lexapro, or with both drugs (when taken individually).

• Can occur with Zulresso:
• dizziness or vertigo (feeling like you’re moving when you’re not)
• feeling like you’re going to faint
• dry mouth
• skin flushing (redness and warm feeling in your skin)
• Can occur with Lexapro:
• insomnia (trouble sleeping)
• nausea
• sweating
• fatigue (lack of energy)
• decreased libido (little or no sex drive)
• not being able to have an orgasm
• delayed ejaculation
• Can occur with both Zulresso and Lexapro:
• sedation (sleepiness, trouble thinking clearly, not being able to drive or use heavy machinery)

Serious side effects

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

• Can occur with Zulresso:
• severe sedation
• loss of consciousness
• Can occur with Lexapro:
• serotonin syndrome (too much serotonin in the body)
• hyponatremia (low sodium levels)
• increased risk of bleeding
• withdrawal due to stopping Lexapro
• angle closure glaucoma (increased pressure in eye)
• Can occur with both Zulresso and Lexapro:
• suicidal thoughts and behaviors in young adults (younger than 25 years old)

Effectiveness

Zulresso and Lexapro have different FDA-approved uses, but they’re both used to treat PPD. This is an off-label use for Lexapro. Don’t use Lexapro to treat PPD without talking with your doctor first.

These drugs haven’t been directly compared in clinical studies. However, studies have found Zulresso to be effective for treating PPD. And a review of studies described a study that found that Lexapro may be effective for treating PPD.

Costs

Zulresso and Lexapro are both brand-name drugs. There are currently no generic forms of Zulresso, but there is a generic form of Lexapro called escitalopram. Brand-name medications usually cost more than generics.

The list price of Zulresso is a total of about $34,000 for the infusion before discounts, according to the manufacturer’s quarterly report. Based on that price and the estimated price of Lexapro from GoodRx, Zulresso is much more expensive. The actual price you’ll pay for either drug will depend on your insurance plan.

How Zulresso is given

You’ll be given Zulresso by your doctor in a healthcare facility. You’ll receive it as an intravenous (IV) infusion, which goes into your vein. An infusion is an injection that lasts a certain length of time. The Zulresso infusion will last about 60 hours (2.5 days).

During this time, you will stay in the healthcare facility. This will allow your doctor to adjust the scheduled dosage. It will also allow them to monitor you for serious side effects, such as sedation and loss of consciousness.

If you have serious side effects, such as loss of consciousness, your doctor will interrupt the infusion. They will treat your side effects before restarting the infusion. In the rare case that your doctor decides it’s not safe for you to continue receiving Zulresso, they will stop the treatment.

When Zulresso is given

Zulresso is given as an infusion over a period of 60 hours (2.5 days). During this time, you will stay in the healthcare facility. You’ll follow a normal schedule for eating and sleeping during your treatment. You can also spend time with visitors, including your child (or children).

Your doctor will likely start the treatment in the morning. This allows them to monitor you for side effects during the day, when you are most likely to be awake.

Taking Zulresso with food

The Zulresso infusion lasts 60 hours (2.5 days), so you will likely eat meals during that time. The healthcare facility will provide meals during your stay.

How Zulresso works

It’s not known exactly how Zulresso helps treat postpartum depression (PPD).

About PPD

PPD is caused in part by an imbalance of the activity of neurosteroids and stress hormones, as well as your overall nervous system. Neurosteroids are steroids that are naturally found in the body. These substances play a role in regulating the activity of your nervous system.

How Zulresso may help

Zulresso is a man-made version of allopregnanolone, a neurosteroid. It’s thought to restore balance to your nervous system and stress hormones. It does this by increasing the activity of certain neurotransmitters (chemicals that send messages between nerve cells).

Specifically, Zulresso increases the activity of gamma aminobutyric acid (GABA), a neurotransmitter that helps produce a calming effect. Increased activity of GABA may help relieve symptoms of PPD.

How long does it take to work?

You’ll likely notice a reduction in your PPD symptoms within a few hours of starting your infusion.

In clinical studies, Zulresso relieved people’s symptoms within two hours of starting the medication.

Zulresso and pregnancy

Zulresso is not meant to be used during pregnancy. It’s approved by the Food and Drug Administration (FDA) for use during the “postpartum” period, which occurs after childbirth.

There aren’t any studies of Zulresso use in humans during pregnancy. In animal studies, Zulresso caused harm to the fetus when the mother received the drug. However, animal studies don’t always predict what will happen in humans.

Before taking Zulresso, tell your doctor if there is a chance you may be pregnant. They will discuss with you the risks and benefits of Zulresso use during pregnancy.

If you do receive Zulresso while pregnant, consider enrolling in a pregnancy registry. Pregnancy registries collect information about drug use during pregnancy to help doctors learn more about the drug’s safety. You can register at the National Pregnancy Registry for Antidepressants or by calling 844-405-6185.

Zulresso and breastfeeding

Breastfeeding during Zulresso treatment is likely safe. A small study in humans found that Zulresso does pass into breast milk. However, it is found in very low levels in breast milk.

Additionally, if a child swallows breast milk that contains Zulresso, the drug will have little to no effect on them. That’s because Zulresso is broken down and made inactive in the child’s stomach. Therefore, children who are breastfed will only receive very small amounts of active Zulresso.

Talk with your doctor about whether breastfeeding during Zulresso treatment is a good option for you.

Common questions about Zulresso

Here are answers to some frequently asked questions about Zulresso.

Can Zulresso treat other types of depression besides postpartum depression?

At this time, it’s not known if Zulresso can treat other forms of depression. Zulresso has only been tested for safety and effectiveness in women who have postpartum depression (PPD).

If you have questions about whether Zulresso is right for you, talk with your doctor.

Why is Zulresso available only at a REMS-certified facility?

Zulresso is only available at a REMS-certified facility because of how severe the side effects can be. REMS (Risk Evaluation and Mitigation Strategies) is a program created by the Food and Drug Administration (FDA). It helps make sure that drugs are used safely and provided by specially trained healthcare professionals.

Zulresso can cause serious side effects, such as severe sedation. Symptoms can include extreme sleepiness, trouble thinking clearly, and not being able to drive or use heavy machinery. Zulresso can also cause sudden loss of consciousness (not being able to respond to sound or touch).

Because of how severe these side effects can be, Zulresso is only given in certain healthcare facilities. These facilities have doctors who are specially trained to monitor and treat the possible side effects of Zulresso. This helps make sure you receive Zulresso safely.

Will I still need to take oral antidepressants after Zulresso treatment?

You might. Just as antidepressants don’t cure other types of depression (they only help relieve symptoms), Zulresso does not cure PPD. Therefore, you may need continued medication for your depression after your treatment with Zulresso.

After you receive Zulresso treatment, you and your doctor will continue to work together to find the best treatment strategies to help you feel your best. Do not stop taking your oral antidepressants unless your doctor tells you to do so.

Can men get postpartum depression, too? If so, can they use Zulresso?

It’s thought that men can also suffer from PPD. An analysis pooled results from studies in 22 different countries that included more than 40,000 men. This analysis found that about 8% of men in the study had depression after their baby was born. More men reported feeling depressed three to six months after the baby was born, compared to other periods of time.

However, it’s not known whether Zulresso is effective at treating PPD in men. Clinical studies of Zulresso have only included women with PPD.

Can Zulresso treat postpartum psychosis?

Not at this time. Zulresso is not FDA-approved to treat postpartum psychosis. Clinical trials for Zulresso did not include women with postpartum psychosis. Therefore, it’s not known whether Zulresso is safe and effective for treating this condition.

Postpartum psychosis causes a woman to experience symptoms that can include:

• hearing voices
• seeing things that aren’t really there
• having extreme feelings of sadness and anxiety

These symptoms are serious. If you experience them, call 911.

Can Zulresso treat postpartum depression in teenagers?

Zulresso is FDA-approved to treat PPD in women ages 18 years and older. Clinical studies have not included females younger than 18. It’s not known whether Zulresso is safe or effective for treating younger teenagers with PPD.

Zulresso precautions

This drug comes with several warnings.

FDA warning: Excessive sedation and sudden loss of consciousness

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

Zulresso can cause severe sedation. Symptoms can include sleepiness, trouble thinking clearly, and not being able to drive or use heavy machinery. Zulresso can also cause sudden loss of consciousness (not being able to respond to sound or touch).

Zulresso is only available through certified facilities. Your doctor will monitor you closely throughout your Zulresso treatment. They will also be present if you are with your child (or children) in case you lose consciousness.

Other warnings

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

• End-stage kidney disease. It’s not known if Zulresso is safe for people with end-stage kidney (renal) disease. If you have end-stage kidney disease and need Zulresso, talk with your doctor about the risks and benefits. They may prescribe a different drug for you.

Note: For more information about the potential negative effects of Zulresso, see the “Zulresso side effects” section above.

Professional information for Zulresso

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

Indications

Zulresso (brexanolone) is approved by the Food and Drug Administration (FDA) to treat postpartum depression (PPD) in adults. It’s the first and only drug the FDA has approved to specifically treat PPD.

Mechanism of action

Zulresso is a synthetic analog of allopregnanolone. The exact mechanism of action of Zulresso is not known, but its effects on PPD are thought to be related to gamma aminobutyric acid (GABA) activity enhancement through positive allosteric modulation. Allosteric modulation occurs when Zulresso binds to a site other than the GABA receptor and amplifies the effect of GABA binding to its receptor. It’s thought that enhancement of GABA activity regulates stress-signaling in the hypothalamic-pituitary-adrenal axis (HPA). Dysfunctional HPA activity plays a role in PPD.

Pharmacokinetics and metabolism

Zulresso exhibits dose-proportional pharmacokinetics. There is extensive distribution into tissues and more than 99% plasma protein binding.

Zulresso is metabolized via non-CYP pathways to inactive metabolites. Terminal elimination half-life is approximately nine hours. In feces, 47% of Zulresso is excreted, while in urine 42% is excreted.

The effects of end-stage renal disease on Zulresso pharmacokinetics is unknown; Zulresso use should be avoided in this population.

Contraindications

There are no contraindications to Zulresso use.

Abuse and dependence

Zulresso is a controlled substance, and it’s classified as a schedule 4 (IV) drug.

Storage

Zulresso should be stored in the refrigerator at 36⁰F–46⁰F (2⁰C–7⁰C). Protect vials from light and don’t freeze.

After dilution, Zulresso can be stored in the infusion bag for up to 12 hours at room temperature. If not used immediately after dilution, it can be stored for up to 96 hours in the refrigerator.

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