Most moms expect some sleepless nights, sore breasts, and some pain as they recover from delivering their baby. What they don’t expect is to be slain by a force so powerful they struggle to meet their baby’s basic needs.

It’s tragic and more common than you might think. The fact is, one in 10 women experience postpartum depression (PPD) and for half of them, PPD is their first episode of depression so many don’t recognize it as a problem.1

To be clear, postpartum depression is not the same as the “baby blues”. The two are related, but the baby blues is a temporary condition triggered by the sudden change in hormonal fluctuations after delivery, sleep deprivation, and stress.1 A new mom with the baby blues feels tearful, overwhelmed, and emotionally fragile. But those feelings typically subside within a month or so following childbirth.

Experts say postpartum depression is largely underdiagnosed and screening for it is inconsistent at best. What’s worse, many women struggling with it either mistakenly believe it’s a normal part of motherhood or feel too ashamed to reveal it to a loved one or their doctor. Having a baby is supposed to be a time of great happiness and joy, isn’t it?

Constant crying, irritability, guilt, anxiety, and paralyzing fatigue really weren’t the emotions you expected when you signed on for motherhood. But when postpartum depression sets in those difficult feelings seem inescapable. PPD can make you feel angry and withdrawn from your newborn (many women want to hurt themselves or their child) and dangerously impact the baby’s cognitive and emotional development.2

Until recently, there’s never been a very good way to treat postpartum depression. Therapy and antidepressant medications can help but neither option works quickly. Being told relief is on the way but it will take another 4 to 6 weeks to feel it can make a bad situation worse.

Given the number of women affected, and the severity of the symptoms, finally having a more effective option is good news. In March 2019, brexanolone (Zulresso) became the first drug to be approved by the US Food and Drug Administration (FDA) specifically for the treatment of postpartum depression in adults, giving new hope to legions of women (and some men) living with PPD.

Here’s what to know.

What is Zulresso?

Zulresso is the brand name for the prescription drug brexanalone. It’s a synthetic form of allopregnanolone, a neurosteroid that acts as an antidepressant when administered to the body.3

Relief from depressive symptoms typically occurs within 48 hours but the treatment isn’t terribly convenient. Brexanalone is administered as an intravenous infusion at a certified healthcare facility over the course of 60 hours. Adults receiving it must be continuously monitored due to the risk of serious side effects including suicidal thoughts in some people.

Zulresso is available only through a Risk Evaluation and Mitigation Strategy (REMS) program. REMS requires treatment recipients to be enrolled in the program prior to receiving the drug.

How effective is Zulresso in treating postpartum depression (PPD)?

Clinical studies have shown Zulresso to be effective in improving the symptoms of PPD. One study included patients with severe PPD and the other included patients with moderate PPD. In both studies, depressive symptoms improved at the end of the first infusion of Zulresso and were observed again at the end of the 30-day follow-up period. Zulresso does not cure PPD, but it can lessen its symptoms.

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How does Zulresso work?

It is not known how exactly how Zulresso (brexanalone) works, but according to experts, it may have something to do with the fact that it is an allosteric modulator of GABA-A receptors. GABA is the primary inhibitory neurotransmitter in the brain and may play an important role in modulating vulnerability to depression and anxiety.

Zulresso Side Effects

Common side effects of Zulresso can include:

  • Sedation (sleepiness)
  • Dizziness or vertigo
  • Feeling faint
  • Dry mouth
  • Flushed skin

Zulresso also carries the risk of more serious side effects including loss of consciousness and suicidal thoughts in adults younger than 25.

Zulresso Dosage

Your doctor will determine the dosage of Zulresso based on your weight. The recommended dosage of Zulresso to treat 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

How much does Zulresso cost?

According to Sage Therapeutics, the biopharmaceutical company taking Zulresso to market, the drug will cost around $7,450 a vial, which amounts to approximately $34,000 before discounts or insurance. It’s important to note that the high price tag does not include the cost of staying at a medical facility for more than two days.

Does Insurance Cover Zulresso?

Speak to your insurance provider to find out about your coverage for treatment with Zulresso. Sage Central offers financial assistance programs to help patients reduce their out-of-pocket costs related to their treatment. Through the Zulresso Drug Co-Pay Assistance Program some patients may be eligible for copay assistance to reduce their out-of-pocket, drug-related copay costs up to $15,000.

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Did you know men can develop postpartum depression?

Read more about PPD in men here.

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Zulresso Warnings

Brexanalone (brand name Zulresso) comes with a boxed warning: the most serious type of warning from the Food and Drug Administration (FDA). Zulresso can cause severe sedation or sudden loss of consciousness during the administration of the drug. Patients must be monitored continuously, and the infusion stopped immediately if the signs of sedation are present.

Patients should discuss their medical history with their doctor before taking Zulresso. Zulresso may not be safe for patients with end-stage kidney (renal) disease.

Zulresso Interactions

Zulresso can interact with many other medications. Below is a list of medications that can interact with Zulresso. This list is not exhaustive and does not include all drugs that may interact with Zulresso. Consult with your doctor about the drugs you take to avoid any potential interactions.

  • Opioids, such as hydrocodone (Hysingla, Zohydro), oxycodone (Oxycontin, Roxicodone, Xtampza ER), codeine, morphine (Kadian, MS Contin), etc.
  • Benzodiazepines, such as alprazolam (Xanax, Xanax XR), diazepam (Valium), lorazepam (Ativan), etc. ·Certain sleep medications, such as eszopiclone (Lunesta), zaleplon (Sonata), zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist), etc.
  • Certain antidepressants, such as fluoxetine (Prozac, Sarafem, Selfemra), sertraline (Zoloft), citalopram (Celexa), escitalopram (Lexapro), etc.

Despite the cost and inconvenience of using Zulresso (60 hours of closely-monitored IV administration that takes you away from your family for more than two days), most women in the clinical trial were so thrilled to have relief from their symptoms they described the process as worth it.

Zulresso FAQS

Is Zulresso safe for breastfeeding women?

Breastfeeding while receiving treatment with Zulresso is likely safe. While Zulresso does pass into breast milk at very low levels, the drug will have little to no effect on the child drinking the breast milk. There are currently no reports on whether brexanalone effects milk production.

What kind of drug is Zulresso?

Brexanalone (brand name Zulresso) is a derivative of allopregnanolone. In the human body, allopregnanolone is a byproduct of the hormone progesterone. While brexanalone has antidepressant effects, it is not in fact an antidepressant, but what is known as a neurosteroid.

When will Zulresso be available for use?

Zulresso became available for use in 2019. Zulresso is available only through a restricted program under a REMS called the Zulresso REMS. Patients must be enrolled in the Zulresso REMS prior to administration of Zulresso.

Is Zulresso a controlled substance?

Zulresso is a controlled substance, which means its use is closely monitored by the federal government. Zulresso is classified as a schedule 4 (IV) drug.

Is there a generic version of Zulresso?

No, Zulresso is available only as a brand-name medication. There is currently no generic version of Zulresso.

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Last Updated: Feb 23, 2021