What is Brexanolone-based Medication (Brand name: Zulresso)?
Zulresso: Dose information, potential adverse reactions, applications, and additional details
This is a specific prescription medication utilized for addressing postpartum depression (PPD) in adults. PPD usually develops within a few weeks or even months post-delivery for some individuals.
Brexanolone-based medication, like Zulresso, does not cure PPD, but it can indeed alleviate its symptoms. These might include persistent feelings of intense sadness, anxiety, and being overwhelmed. PPD can make it challenging to care for the newborn, and it can have significant negative impacts on both the individual and their family.
The drug is administered as an intravenous (IV) infusion, which is directly injected into a vein. This treatment process takes 60 hours (around 2.5 days). During this time, you'll be confined to a specialized healthcare facility to ensure safety and proper administration of the medication (it's not yet determined if multiple treatments are safe or effective).
Efficacy
In clinical studies, this medication demonstrated better results in easing PPD symptoms than a placebo (a treatment without an active drug). The depression severity scale score for PPD ranges from 0 to 52 points. A depression score of 20 to 25 indicates moderate PPD, while 26 points or above signifies severe PPD.
One study focused on women with severe PPD. The women who underwent the 60-hour Zulresso infusion saw improvements in their depression scores by 3.7 to 5.5 points compared to placebo group members.
In another study focusing on women experiencing moderate PPD, Zulresso improved depression scores by 2.5 points more than a placebo after the 60-hour IV infusion.
FDA Approval
The Food and Drug Administration (FDA) approved this medication in March 2019, marking it as the first and only drug specifically approved to tackle PPD. However, it's not yet available for use (see "Is Zulresso a controlled substance?" below).
Is Brexanolone-based Medication (Zulresso) a Controlled Substance?
Yes, it is a controlled substance, meaning its usage is closely regulated by the federal government. Each controlled substance is assigned a schedule based on its medical utility and potential for misuse. Zulresso is classified as a schedule 4 (IV) drug.
Zulresso should be accessible in late June 2019.
The government has set up unique regulations for dispensing each category of scheduled drugs. Your doctor and pharmacist can provide more information about these regulations.
Availability of Zulresso's Generic Version
At the moment, Zulresso is only available as a brand-name medication. There's no generic version available.
Zulresso contains the active ingredient, brexanolone.
Zulresso's Cost
The cost of Zulresso can vary, just like any other medication. Manufacturer Sage Therapeutics states that the list price for one vial is $7,450, and treatment often requires an average of 4.5 vials, resulting in a total cost of approximately $34,000 before discounts. The actual cost you pay depends on your insurance plan.
Financial Assistance and Insurance Coverage
If financial assistance is necessary to afford Zulresso, there's help available. Sage Therapeutics has announced they will offer financial aid programs for eligible patients.
To learn more, you can contact Sage Therapeutics at 617-299-8380. For updated information, you can also visit the company's website.
Zulresso Side Effects
Zulresso can cause several mild or serious side effects. The following outlines some of the common side effects associated with this medication, keeping in mind this isn't an exhaustive list.
For further details on Zulresso's potential side effects, speak with your doctor or pharmacist. They can provide tips on managing any bothersome side effects.
More common side effects
Common side effects of Zulresso may include:
- Drowsiness (sleepiness, difficulty thinking clearly, inability to operate heavy machinery)
- Dizziness or vertigo (sensation of spinning)
- Feeling faint
- Dry mouth
- Skin flushing (redness and warmth on the skin)
Most of these side effects usually subside within a few days or two weeks. If they're severe or persist, feel free to discuss with your doctor or pharmacist.
Serious side effects
More serious side effects from Zulresso can occur. If you encounter serious side effects post-leave from the healthcare facility, consult your doctor immediately. Call 911 if you think you're having a medical emergency or if your symptoms seem life-threatening.
Serious side effects and their symptoms might include the following:
- Loss of consciousness (symptoms may include feeling faint, weak, or disoriented)
- Suicidal thoughts and behaviors in young adults (under 25 years old)
These effects can also impact children, as this medication is not approved for use in children.
Similar to many drugs, some individuals might encounter an adverse reaction following the consumption of Zulresso. Indicators of a mild adverse reaction might include:
- a skin rash
- itching
- feeling warm and reddened on your skin (flushing)
Although a more severe adverse reaction is less common, it's possible. Symptoms of a severe adverse reaction could include:
- angioedema (swelling under the skin, typically affecting areas like the eyelids, lips, hands, or feet)
- swelling of the tongue, mouth, or throat
- difficulty breathing
If you experience a severe adverse reaction to Zulresso after leaving the medical facility, promptly contact your doctor. In situations where the symptoms appear life-threatening or suggest a medical emergency, dial 911 immediately.
Sedation and Loss of Consciousness
Sedation often occurs as a side effect of Zulresso. Signs of sedation include drowsiness and trouble concentrating. In some instances, sedation may turn severe, leading to profound drowsiness and even loss of consciousness.
In clinical trials, 5% of individuals experienced severe sedation that necessitated a temporary halt or modification in treatment. Conversely, in individuals receiving a placebo (an inactive treatment), none displayed the same reaction.
Loss of consciousness refers to fainting or appearing to be asleep. During this period, you're unable to respond to sounds or touch. In the clinical trials, 4% of individuals who consumed Zulresso experienced loss of consciousness. On the other hand, none of the individuals receiving a placebo experienced this symptom.
For each individual who lost consciousness in the studies, treatment was suspended. The recovery process typically took between 15 to 60 minutes following the cessation of treatment.
During the administration of Zulresso, your doctor will monitor you for loss of consciousness. This monitoring occurs every 2 hours during wakeful periods (following a regular sleep schedule during treatment).
Both severe sedation and loss of consciousness can result in reduced oxygen levels (hypoxia). If you become sedated or lose consciousness, your breathing may slow down, leading to diminished oxygen intake. Inadequate oxygen in your cells and tissues can cause harm to your brain, liver, and various organs.
For this reason, your doctor will keep track of the oxygen levels in your blood throughout your treatment. If loss of consciousness or reduced oxygen levels in your blood occur, your doctor may temporarily halt the Zulresso treatment. In certain cases, they may subsequently administer the drug at a lower dose.
Given the risk of loss of consciousness, Zulresso is administered by healthcare professionals licensed to administer this treatment.
[Production: Insert Pros-Cons Suicide Prevention Widget]
Zulresso for Postpartum Depression (PPD)
The Food and Drug Administration (FDA) approves prescription medications, such as Zulresso, to treat certain conditions.
Zulresso has been authorized by the FDA to treat adults experiencing Postpartum Depression (PPD). This condition is a severe form of major depression that emerges within weeks to months following childbirth. It's more severe than the "baby blues" that many women experience shortly after delivery. Untreated PPD may make a mother less capable of caring for her baby.
PPD may be caused by various factors, including:
- alterations in hormone levels
- fatigue (lack of energy)
- poor or irregular diet
- changes in your social or professional life (such as spending more time at home)
- changes in your sleep schedule
- feelings of loneliness
Symptoms of postpartum depression can include:
- extreme exhaustion
- anxiety
- significant mood swings
- feelings of self-blame as a mother
- trouble sleeping or eating
- concerns about harming yourself or others
- suicidal thoughts or behaviors
In clinical trials, Zulresso effectively alleviated PPD symptoms to a greater extent than a placebo (an inactive treatment). The trials employed a rating scale to assess the severity of each individual's depression prior to and after being administered Zulresso. The rating scale possesses a maximum score of 52 points, with higher scores indicating more severe depression. According to the trials, moderate PPD is characterized by a score of 20 to 25 points, while severe PPD is marked by a score of 26 points or higher.
One trial included individuals with severe PPD. After the 60-hour Zulresso infusion, depression scores for these individuals improved by 3.7 to 5.5 more points than the scores of individuals receiving a placebo. In another trial that included individuals with moderate PPD, Zulresso improved depression scores by 2.5 more points than a placebo following the 60-hour infusion.
Zulresso Dosage
The dosage of Zulresso prescribed by your doctor will depend on your body's response to the drug.
Your doctor will commence treatment with a low dose, which they'll gradually increase over several hours. They'll adjust it according to your body's tolerance, aiming to reach an amount that minimizes severe side effects without causing harm. In the latter stages of the treatment, they'll decrease the dose again.
The following information outlines commonly used or recommended dosages. Your doctor will determine the best dosage for your specific needs.
Drug Forms and Strengths
Zulresso is available as a solution intended for intravenous (IV) infusion, which is administered into your vein. Treatment involves receiving the infusion over a period of 60 hours (2.5 days). You will be required to remain in a medical facility for the entirety of the infusion.
Dosage for Postpartum Depression (PPD)
Your doctor will base your dosage on your weight. A kilogram (kg) equates to approximately 2.2 pounds.
The recommended dosage of Zulresso for PPD is:
- Initial infusion duration from hour 1 to 3: 30 mcg/kg every hour
- Hours 4 to 23: 60 mcg/kg every hour
- Hours 24 to 51: 90 mcg/kg every hour
- Hours 52 to 55: 60 mcg/kg every hour
- Hours 56 to 60: 30 mcg/kg every hour
If you experience serious adverse effects during the infusion, your doctor might halt the treatment or decrease the dosage of Zulresso. They may choose to restart the treatment or maintain the dosage if they deem it safe for you to continue using Zulresso.
Will I need to use this drug for an extended period?
Zulresso is not intended for long-term use. Following your Zulresso treatment, you and your doctor can discuss suitable, long-term antidepressant treatments that you might require.
Zulresso and alcohol
Avoid consuming alcohol in the hours preceding or during your Zulresso treatment. Alcohol may intensify the risk of severe sedation (drowsiness, difficulty in thinking clearly) when consumed alongside Zulresso. It may also increase the risk of fainting (losing consciousness and the inability to respond to sound or touch).
If you have reservations regarding avoiding alcohol around your treatment time, consult your doctor. You can also discuss the safety of drinking alcohol after your treatment has concluded.
Zulresso drug interactions
Zulresso can react with various other medications.
Different interactions may produce varying results. For instance, some interactions may interfere with a drug's effectiveness. Other interactions may escalate side effects or make them more severe.
Zulresso and other medications
Below is a list of medications that may interact with Zulresso. This list is not exhaustive and may exclude some drugs that could interact with Zulresso.
Before taking Zulresso, communicate with your doctor and pharmacist. Disclose all prescription, over-the-counter, and additional drugs you take. Share information 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 could impact you, consult your doctor or pharmacist.
Zulresso and opioids
Administering pain medications, such as opioids, before or during Zulresso treatment might increase the risk of severe adverse effects. Taking Zulresso with opioids can escalate the risk of severe sedation (drowsiness, difficulty in thinking clearly, and inability to drive or operate heavy machinery). It may also augment your risk of fainting (loss of consciousness and the inability to respond to sound or touch).
Examples of opioids that can increase the risk of sedation and fainting 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 blend of opioids and additional drugs. Be sure to inform your doctor about all medications you take. If you're taking a pain medication, they may advise against taking it before and during Zulresso treatment. This will help decrease the risk of severe sedation and fainting.
Zulresso and certain anxiety medications
Taking Zulresso with benzodiazepines (medications used to treat anxiety) might increase the risk of severe adverse effects. Taking Zulresso with a benzodiazepine can escalate the risk of severe sedation (drowsiness, difficulty in thinking clearly, inability to drive or operate heavy machinery). It may also amplify your risk of fainting (loss of consciousness and the inability to respond to sound or touch).
Examples of benzodiazepines that can increase the risk of sedation and fainting 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 (difficulty sleeping) might increase the risk of severe sedation. Symptoms of sedation can include drowsiness, difficulty in thinking clearly, inability to drive or operate heavy machinery, and fainting (loss of consciousness and the inability to respond to sound or touch).
Examples of insomnia medications that can increase the risk of sedation and fainting if taken with Zulresso include:
- eszopiclone (Lunesta)
- zaleplon (Sonata)
- zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist)
- fluoxetine (Prozac, Sarafem, Selfemra)
- paroxetine (Brisdelle, Paxil, Pexeva)
- sertraline (Zoloft, generic sertraline)
- nortriptyline (Pamelor)
- amitriptyline
- bupropion (Wellbutrin SR, Wellbutrin XL, Zyban)
- esketamine (Spravato)
Alternatives to Zulresso for Postpartum Depression (PPD)
Various medications, approved for different conditions, can be utilized off-label for treating PPD. Discuss these alternatives with your doctor to determine which might be most beneficial for you.
Some potential medications for off-label use in treating PPD include:
- fluoxetine (Prozac, Sarafem, Selfemra)
- paroxetine (Brisdelle, Paxil, Pexeva)
- sertraline (Zoloft, generic sertraline)
- nortriptyline (Pamelor)
- amitriptyline
- bupropion (Wellbutrin SR, Wellbutrin XL, Zyban)
- esketamine (Spravato)
Zulresso vs. Sertraline (Zoloft)
So, how do Zulresso and Sertraline (Zoloft) compare in treating similar conditions? Let's delve into their similarities and differences.
Uses
Zulresso and Sertraline (Zoloft) are FDA-approved for different indications.
Zulresso is approved for treating postpartum depression (PPD) in adults.
Sertraline (Zoloft) is FDA-approved to treat the following conditions in adults:
- major depressive disorder
- panic disorder
- post-traumatic stress disorder
- premenstrual dysphoric disorder
- social anxiety disorder
Sertraline (Zoloft) is also approved to treat people aged 6 and older with obsessive-compulsive disorder. It's used off-label to treat PPD.
Drug forms and administration
Zulresso is provided as a solution administered intravenously (IV) over a 60-hour period (approximately 2.5 days) in a healthcare facility.
Sertraline (Zoloft) is available in tablet or solution forms, which are taken orally once daily.
Side effects and risks
Since Zulresso and Sertraline (Zoloft) are made with different drugs, they may lead to different adverse effects. The following list contains some examples of these side effects.
More common side effects
This section includes examples of more frequent side effects associated with Zulresso and Sertraline (Zoloft).
- Possible with Zulresso:
- sedation (drowsiness, impaired cognitive function, inability to operate heavy machinery)
- dizziness or vertigo (sensation of movement when none occurs)
- fainting sensation
- dry mouth
- skin flushing (redness, warmth in skin)
- Possible with Sertraline (Zoloft):
- nausea
- diarrhea or loose stools
- stomach upset
- lack of appetite
- excessive sweating
- tremor (uncontrolled body movement)
- difficulty achieving ejaculation
- decreased libido (low sex drive)
Serious side effects
Lists below provide examples of potentially serious side effects associated with Zulresso, Sertraline (Zoloft), or both medications, taken individually.
- Possible with Zulresso:
- severe sedation
- loss of consciousness (unresponsiveness to external stimuli)
- Possible with Sertraline (Zoloft):
- serotonin syndrome (elevated serotonin levels)
- increased bleeding risk
- hyponatremia (low sodium levels in blood)
- abnormal heart rhythm
- discontinuation rebound symptoms
- angle-closure glaucoma (increased eye pressure)
- Possible with both Zulresso and Sertraline (Zoloft):
- suicidal thoughts and behaviors in individuals under the age of 25
Effectiveness and cost
Both Zulresso and Sertraline (Zoloft) are not approved for the same conditions, but both can be used to treat PPD off-label, with Sertraline (Zoloft) being the more common choice.
Unfortunately, direct comparison studies between Zulresso and Sertraline (Zoloft) in treating PPD are unavailable, as they are approved for different conditions. Nevertheless, studies suggest that Zulresso is effective in addressing PPD, while the effectiveness of Sertraline (Zoloft) in treating PPD is inconsistent between studies.
When it comes to cost, Zulresso is a brand-name drug with no generic alternatives at the moment, whereas Sertraline (Zoloft) has a generic version (sertraline) available, which tends to be more affordable.
Zulresso and Lexapro, both prescribed for diverse therapeutic indications, share some similarities and differences.
Uses and Approval
Zulresso, a medication containing brexanolone, is approved by the Food and Drug Administration (FDA) for treating postpartum depression (PPD) in adults. On the other hand, Lexapro, containing escitalopram, is approved for major depressive disorder in individuals aged 12 years and above, and adult patients suffering from generalized anxiety disorder. Additionally, Lexapro is utilized off-label for PPD treatment.
Drug Forms and Administration
The two medications have diverse forms of administration. Zulresso is presented as an intravenous (IV) infusion solution and is administered in healthcare facilities over a stretch of approximately 60 hours (2.5 days). Meanwhile, Lexapro comes in tablet and solution form and is taken orally once daily.
Side Effects and Risks
Due to the varying active ingredients, Zulresso and Lexapro have distinct side effects and risks. For Zulresso, more common side effects include dizziness, feeling lightheaded, dry mouth, and skin flushing. Lexapro, on the other hand, can result in insomnia, nausea, sweating, reduced sex drive, difficulty in reaching orgasm, and delayed ejaculation. Common side effects for both medications may include sedation, sleepiness, trouble thinking clearly, and difficulty in operating heavy machinery.
Serious Side Effects
Zulresso may cause severe sedation and loss of consciousness, whereas Lexapro-related adverse events can include serotonin syndrome, hyponatremia, and increased risk of bleeding. Both medications may incur withdrawal symptoms and angle closure glaucoma. Another serious side effect to consider is the increased risk of suicidal thoughts and behaviors in young adults (under 25 years old) for both medications.
Effectiveness
Although Zulresso and Lexapro have distinct approvals, Zulresso is also used off-label for PPD treatment, while Lexapro may potentially help in treating PPD (with doctor consultation). Despite the absence of direct clinical trials comparing the two, both have demonstrated effectiveness in addressing PPD.
Costs
Both medications are brand-name drugs. Brand-name options tend to be more expensive than generic alternatives. Although the manufacturer's quarterly report mentions a list price of about $34,000 for Zulresso infusions before discounts, the actual cost is subject to insurance coverage. Lexapro has a generic equivalent called escitalopram.
Paraphrased text:
The cost of Zulresso before insurance discounts is about $34,000, as per the company's quarterly report. Your insurance plan determines the final price you pay for either drug.
Zulresso vs. Lexapro
Zulresso and Lexapro share similar therapeutic uses, but they differ in some aspects.
Approved Uses
Zulresso, a drug consisting of brexanolone, is authorized by the FDA to manage postpartum depression (PPD) in adults. In contrast, Lexapro, which contains escitalopram, is approved for major depressive disorder in people aged 12 and above, as well as for treating generalized anxiety disorder in adults. Lexapro also finds off-label use in tackling PPD.
Forms and Administration
Zulresso is available as an IV infusion solution, administered over a period of approximately 60 hours (2.5 days) in a healthcare facility. Lexapro, on the other hand, exists in two forms – tablet and solution, both taken orally once daily.
Side Effects and Risks
The two medications exhibit distinct side effects and risks due to their different active ingredients. For Zulresso, common side effects include dizziness, feeling lightheaded, dry mouth, and skin flushing. Lexapro can result in insomnia, nausea, sweating, reduced sex drive, difficulty in reaching orgasm, and delayed ejaculation. Common side effects for both medications may include sedation, sleepiness, trouble thinking clearly, and difficulty in operating heavy machinery.
Serious Side Effects
Zulresso may cause severe sedation and loss of consciousness, whereas Lexapro-related adverse events can include serotonin syndrome, hyponatremia, and increased risk of bleeding. Both medications may incur withdrawal symptoms and angle closure glaucoma. Another serious side effect to consider is the increased risk of suicidal thoughts and behaviors in young adults (under 25 years old) for both medications.
Effectiveness
Although Zulresso and Lexapro have distinct approvals, Zulresso is also used off-label for PPD treatment, while Lexapro may potentially help in treating PPD (with doctor consultation). Despite the absence of direct clinical trials comparing the two, both have demonstrated effectiveness in addressing PPD.
Costs
Both medications are brand-name drugs. Brand-name options tend to be more expensive than generic alternatives. Although the manufacturer's quarterly report mentions a list price of about $34,000 for Zulresso infusions before discounts, the actual cost is subject to insurance coverage. Lexapro has a generic equivalent called escitalopram.
Zulresso's infusion period lasts 60 hours, or approximately 2.5 days, so you'll probably consume meals during this time. The healthcare facility where you're staying will provide these meals for you.
Understanding Zulresso
The precise mechanism by which Zulresso aids in managing postpartum depression (PPD) is not fully understood.
PPD Explained
PPD often stems from a disruption in the balance of neurosteroids and stress hormones, as well as an overall impact on your nervous system. Neurosteroids are naturally occurring substances in the body that play a role in regulating your nervous system's activity.
Zulresso's Role
Zulresso is a synthetic form of allopregnanolone, a neurosteroid. It's believed to restore balance to your nervous system and stress hormones by enhancing the activity of specific neurotransmitters. These are chemicals that facilitate communication between nerve cells.
Particularly, Zulresso increases the activity of gamma aminobutyric acid (GABA), a neurotransmitter that helps produce a soothing effect. An increase in GABA activation may help alleviate symptoms of PPD.
Timing
You may observe an improvement in your PPD symptoms within a few hours of beginning the infusion.
In clinical trials, Zulresso led to a reduction in symptoms within two hours of administration of the medication.
Zulresso and Pregnancy
Zulresso is not intended for use during pregnancy. It's FDA-approved for utilization during the "postpartum" phase, following childbirth.
There have been no studies on Zulresso usage in pregnant individuals. In animal studies, Zulresso triggered harm to the fetus when the mother was administered the drug. However, animal studies do not always accurately predict human outcomes.
Before taking Zulresso, inform your doctor if there is a possibility of pregnancy. They will help evaluate the potential risks and benefits of using Zulresso during pregnancy.
If you do receive Zulresso while pregnant, consider registering in a pregnancy registry. Pregnancy registries collect data on drug use during pregnancy to aid doctors in understanding 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 present in very low levels in breast milk.
If a baby consumes breast milk containing Zulresso, the drug will have minimal-to-no impact on the baby. This is because Zulresso is broken down and rendered inactive in the baby's stomach. As a result, babies who are breastfed will only receive minimal doses of active Zulresso.
Discuss breastfeeding during Zulresso treatment with your doctor to determine what's best for you.
Commonly Asked Questions about Zulresso
Can Zulresso treat various forms of depression aside from postpartum depression?
At this point, it's unclear if Zulresso can be used to treat other types of depression. Zulresso has only been tested for safety and efficacy in women with PPD.
If you have questions about whether Zulresso is suitable for you, consult your doctor.
Why is Zulresso only available at a REMS-certified facility?
Zulresso is available only at a REMS-certified facility due to the potential severity of its side effects. REMS is a program created by the FDA to ensure that drugs are used safely and provided by specially trained healthcare professionals.
Zulresso can cause severe side effects, such as intense sedation. Symptoms can include extreme drowsiness, difficulty in thinking clearly, and inability to drive or operate heavy machinery. Zulresso can also result in sudden loss of consciousness.
Due to the severity of these side effects, Zulresso is only administered in specific healthcare facilities. These facilities have doctors who are trained to monitor and treat the possible side effects of Zulresso, ensuring your safety.
Will I still need to take oral antidepressants after Zulresso treatment?
This is a possibility. Just as antidepressants do not cure other forms of depression (they only help manage symptoms), Zulresso does not cure PPD. Consequently, you may require ongoing medication for your depression following Zulresso treatment.
After you receive Zulresso treatment, you and your doctor will continue to work together to develop the best treatment strategies for your optimal well-being. Do not discontinue your oral antidepressants unless your doctor instructs you to do so.
Can men suffer from PPD, and if so, can they use Zulresso?
It's believed that men can also experience PPD. A meta-analysis of studies across 22 different countries involving more than 40,000 men revealed that about 8% of the men in the study suffered from depression post-birth. More men reported feelings of depression three to six months after the baby's birth compared to other time periods.
That being said, it's unclear if Zulresso is effective at treating PPD in men. Clinical trials of Zulresso have only included women with PPD.
Does Zulresso tackle postpartum psychosis?
At the moment, it doesn't. Zulresso isn't FDA-authorized to manage postpartum psychosis. Research trials for Zulresso didn't feature women dealing with postpartum psychosis. Consequently, it's unclear if Zulresso is safe and effective for managing this particular disorder.
Postpartum psychosis triggers symptoms such as:
- Hearing hallucinations
- Seeing non-existent things
- Extreme bouts of sadness and anxiety
These symptoms are severe. If you encounter them, dial 911.
Can Zulresso handle postpartum depression in teenagers?
Zulresso has FDA approval to treat PPD in women aged 18 and above. Studies have omitted females under 18. It's yet unknown if Zulresso is secure or beneficial for treating young teenagers with PPD.
Zulresso precautions
This medication comes with a number of warnings.
FDA warning: Extreme drowsiness and sudden loss of consciousness
Zulresso carries a boxed warning from the FDA. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that might be hazardous.
Zulresso can induce severe drowsiness. Symptoms include sleepiness, trouble focusing, and failing to operate heavy machinery or drive. Zulresso can also trigger sudden loss of consciousness (being unresponsive to sound or touch).
Zulresso is only accessible through certified facilities. Your doctor will keep a close eye on you throughout your Zulresso treatment. They will also be present if you're with your child (or children) in case you lose consciousness.
Other warnings
Before taking Zulresso, consult with your doctor about your medical history. Zulresso might not be suitable for individuals with certain medical conditions. These include:
- End-stage kidney disease. It's uncertain if Zulresso is secure for people with end-stage kidney (renal) disease. If you have end-stage kidney disease and require Zulresso, discuss the pros and cons with your doctor. They might prescribe an alternate drug for you.
Note: For further information about the potential negative effects of Zulresso, see the “Zulresso side effects” section above.
Professional information for Zulresso
The following information is intended for healthcare professionals.
Indications
Zulresso (brexanolone) is endorsed by the 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 believed to be linked 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 shows dose-proportional pharmacokinetics. There's 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 uncertain; 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.
Disclaimer: Our Website has made every effort to ensure 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.
After reading the provided text, here are two sentences that follow and contain the term 'personality disorders':
- It's crucial to note that Brexanolone-based medication, such as Zulresso, is not a treatment option for individuals suffering from personality disorders.
- While Zulresso is primarily used to treat postpartum depression, patients with concurrent personality disorders may require additional care, as antidepressant medications may interact with their symptoms or existing treatments for the personality disorder.
