*An off-label use of a medication is a use that is not FDA-approved. Prescribers can decide to use a medication off-label because, in their professional judgment, they believe it may offer a benefit to someone.
Zurzuvae (zuranolone) is a recently approved medication for postpartum depression that may cause side effects such as dizziness, drowsiness, and nausea. It may also cause headaches or sleep disturbances. Contact your doctor if these persist. Serious side effects are rare, but seek medical help for mood changes or allergic reactions.
If you are considering Zurzuvae or want to discuss your current medication treatment with a provider, online psychiatry platforms, such as Talkiatry and Brightside Health are a good place to start. Their providers offer assessments and prescription consultation, and can answer any questions you have about Zurzuvae side effects.
Boxed Warning: Zurzuvae – Risk of impairment when driving or engaging in other activities
Zurzuvae has a black box warning. These are the most serious types of warnings from the Food and Drug Administration (FDA). Zurzuvae can cause impairment for up to 12 hours and individuals should not drive or perform hazardous activities for at least 12 hours after taking Zurzuvae. Zurzuvae may also cause decreased awareness and alertness [central nervous system (CNS) depressant effects].
Zurzuvae is a controlled substance, which means that it’s more likely to be misused or cause dependence. There are federal and state laws that limit the amount of medication that can be prescribed or dispensed within a certain period of time.
What Is Zurzuvae & How Is It Used?
Zurzuvae belongs to a class of drugs known as neuroactive steroids. It was recently FDA-approved as the first oral treatment for postpartum depression and contains the active ingredient zuranolone. It acts on GABA receptors in the brain, leading to calming and mood-stabilizing effects. It’s FDA-approved to treat postpartum depression (PPD) in adults.1
Zurzuvae offers a new approach as a rapid-acting oral therapy for this condition, with the potential to alleviate symptoms within 14 days of treatment.2
Is Zurzuvae FDA-approved?
Zurzuvae has received FDA approval as the first oral treatment for postpartum depression in adults. Previously PPD treatment was only available as an IV injection given by a health care provider in certain health care facilities.
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How Does Zurzuvae Work?
Zurzuvae is a medication belonging to the neuroactive steroid class. It acts on GABA receptors, providing rapid relief for postpartum depression (PPD) in adults. With its potential to alleviate symptoms within days, Zurzuvae offers new hope for those struggling with PPD. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and assists with regulating brain function. Altered neurotransmission of GABA has been implicated in the pathogenesis of depression.1
Common Side Effects of Zurzuvae
During clinical trials of Zurzuvae, some common side effects were observed. These typically included drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infections. While these effects are generally manageable, it’s advised to exercise caution when engaging in activities requiring alertness.
Other reported side effects encompassed headaches and sleep disturbances. It’s important to note that certain side effects might require medical attention if they persist or worsen. As with any medication, discussing potential side effects with a healthcare provider ensures a thorough understanding and appropriate management.1
Common side effects of Zurzuvae include:*3
- Somnolence (drowsiness)
- Dizziness
- Diarrhea
- Fatigue
- Nasopharyngitis (common cold)
- Urinary tract infection
- Headache
*All medications, including Zurzuvae, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
Serious Side Effects of Zurzuvae
While serious side effects of Zurzuvae are uncommon, they necessitate prompt medical attention if they occur. These potentially severe effects include significant mood changes such as increased agitation, restlessness, or suicidal thoughts. Additionally, any signs of an allergic reaction, such as rash, itching, swelling, severe dizziness, or difficulty breathing, should be taken seriously.
If you experience any of these reactions while taking Zurzuvae, it’s crucial to seek immediate medical help. Always prioritize your safety and well-being by discussing any concerns with your healthcare provider.
Serious side effects of Zurzuvae include:*3
- Sudden mood changes
- Increased agitation
- Allergic reactions
- Worsening of depression or suicidal thoughts
*All medications, including Zurzuvae, can cause side effects which can be mild or serious. This is not a comprehensive list of all possible side effects. You should talk with your doctor about any questions you have and to understand the potential side effects and benefits of any medication.
Zurzuvae Warnings & Precautions
Zurzuvae can cause CNS depressant effects such as somnolence (fatigue and tiredness) and confusion. If you develop CNS depression, your doctor may look at lowering your Zurzuvae dose or suggesting a different medication.d. Suicidal thoughts and behaviors may also worsen with Zurzuvae use. A provider may consider changing the therapeutic regimen, including discontinuing Zurzuvae, in patients whose PPD worsens or who are experiencing emergent suicidal thoughts and behaviors.4
Zurzuvae has also been noted to likely cause fetal harm. It is advised that pregnant individuals do not take this medication. Providers should also be sure to inform individuals of the reproductive potential of the potential risk to a fetus and to use effective contraception during Zurzuvae usage.1
Precautions for taking Zurzuvae include:1
- Mood changes and suicidal thoughts: Zurzuvae may lead to mood changes, including increased agitation, restlessness, or suicidal thoughts. Prompt medical attention is essential if such changes occur.
- Allergic reactions: Some individuals may experience allergic reactions to Zurzuvae, resulting in symptoms like rash, itching, swelling, severe dizziness, or difficulty breathing. Seek immediate medical help if any of these symptoms arise.
- Drug interactions: Zurzuvae might interact with other antidepressants or medications that affect the central nervous system, potentially affecting their efficacy or causing adverse effects. Discuss all current medications with your healthcare provider to prevent any potential interactions.
- Use in pregnancy and breastfeeding: Zurzuvae may cause fetal harm during pregnancy and should not be given. For people of childbearing age, contraception is recommended when taking Zurzuvae. Consult your healthcare provider before using this medication if you are pregnant, planning to become pregnant, or breastfeeding.
- Abrupt discontinuation: Abruptly stopping Zurzuvae can lead to withdrawal symptoms or a return of the underlying depressive symptoms. It’s important to follow your healthcare provider’s guidance for discontinuing the medication.
- Driving and activities requiring alertness: Zurzuvae can cause drowsiness and dizziness, affecting your ability to perform tasks that require alertness. Avoid driving or operating machinery until you know how the medication affects you.
- Alcohol and CNS depressants: Combining Zurzuvae with alcohol or other central nervous system (CNS) depressants can increase the risk of drowsiness and respiratory depression. Avoid consuming alcohol or using other CNS depressants while taking Zurzuvae.
Allergic Reactions
While allergic reactions have not been noted in the current studies testing Zurzuvae, it is important to note that there is still potential for allergic reactions to occur with the use of this medication. These reactions could manifest as symptoms such as rash, itching, swelling, severe dizziness, or difficulty breathing. It’s important to note that the occurrence of allergic reactions might vary from individual to individual. If you experience any of these symptoms after taking Zurzuvae, seeking immediate medical attention is vital to prevent escalation.4
Allergic reactions to Zurzuvae may include:1
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin
- Tightness in the chest or throat, trouble breathing, swallowing, or talking
- Swelling of the mouth, face, lips, tongue, or throat.
*If someone experiences allergic reactions after taking Zurzuvae, they should seek immediate medical attention. Allergic reactions can escalate quickly and may pose serious health risks.
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How to Manage Side Effects of Zurzuvae
Managing Zurzuvae’s side effects involves several strategies. For common effects like dizziness or drowsiness, avoiding activities requiring alertness and adjusting the timing of medication might help. Nausea could be mitigated by taking the medication with fatty food. Headaches or sleep disturbances may improve with time.2
Drowsiness
Drowsiness is a common side effect of Zurzuvae that can manifest as excessive sleepiness or a general lack of alertness. This drowsiness might impair your ability to concentrate, perform tasks, or drive safely. It’s important to avoid activities that require mental focus or physical coordination until you understand how Zurzuvae affects you.
If drowsiness becomes problematic, consider taking the medication at bedtime to minimize its impact on daytime activities. However, if drowsiness persists or worsens, it’s advisable to consult your healthcare provider. They can offer guidance on potential adjustments to your dosage or timing, or recommend other strategies to manage this side effect effectively while ensuring your overall well-being. To reduce the risk of harm, patients should not drive or operate heavy machinery for at least 12 hours after taking Zurzuvae.2
Headache
Headaches are a possible side effect of taking Zurzuvae and can range from mild discomfort to more severe pain. These headaches might arise due to changes in neurotransmitter levels or other physiological responses. While they are generally manageable, frequent or severe headaches could impact your daily activities and overall well-being.
Staying hydrated, maintaining a regular sleep schedule, and managing stress can help reduce the likelihood of headaches. Over-the-counter pain relievers might provide relief for mild cases, but it’s important to consult your healthcare provider before using any new medications.
Nausea and Vomiting
Nausea and vomiting can arise as side effects of Zurzuvae, causing discomfort and potential disruption to daily activities. Nausea may be experienced as a feeling of queasiness or an urge to vomit, while vomiting involves the forceful expulsion of stomach contents. These effects might lead to decreased appetite and fluid intake, potentially impacting your overall well-being.
To manage nausea, taking Zurzuvae with fat-containing foods can often help alleviate symptoms. Consuming smaller, more frequent meals and staying hydrated might also be beneficial. However, if nausea and vomiting persist or become severe, it’s advisable to consult your healthcare provider.1
Urinary Tract Infections
Urinary tract infections (UTIs) are a potential side effect associated with Zurzuvae. UTIs can manifest as discomfort or pain while urinating, increased frequency of urination, and a persistent urge to urinate. These infections occur when bacteria enter the urinary tract and can lead to discomfort, pain, and potential complications if left untreated.1
To manage and prevent UTIs, maintaining good hygiene practices, staying hydrated, and urinating after sexual activity can be beneficial. If you experience symptoms of a UTI, it’s important to consult your healthcare provider promptly. They can diagnose the infection, prescribe appropriate antibiotics if necessary, and offer guidance on strategies to prevent future occurrences.
*It’s important to remember that individual experiences with Zurzuvae can vary, and the list of potential side effects provided may not encompass every possibility. Before starting any medication, including Zurzuvae, it’s crucial to have an open discussion with your healthcare provider.
Questions to Ask Your Healthcare Provider About Zurzuvae Side Effects
Learning about Zurzuvae’s side effects is essential when considering its use to manage depression. When discussing Zurzuvae with your doctor, psychiatrist, and therapist, inquire about common and rare side effects, how to manage them, and when to seek medical attention. Ensure you’re aware of potential interactions with other medications and share your medical history for personalized advice.
If you’re considering Zurzuvae and need to switch prescribers, online psychiatry services can offer a convenient option. They allow you to consult a qualified professional who can guide you through side effects, and medication adjustments, and ensure a smooth transition in your treatment plan.
Questions to ask your care team about Zurzuvae side effects:
- How long will it take for me to adjust to taking Zurzuvae?
- Am I at risk for more serious symptoms if I am already taking other anxiety /depression medications?
- What is the best dosage to ensure fewer side effects?
- How should I take this medication, what time of day, and what food should I eat with it?
- When should I reach out to you if I am experiencing sexual side effects?
- Is there anything I should tell my therapist about this new medication?
- What are the common and rare side effects associated with Zurzuvae?
- How can I manage potential side effects like dizziness, drowsiness, nausea, headaches, and sleep disturbances?
- Are there any specific interactions with other medications or substances that I should be aware of?
- How can I differentiate between normal side effects and potential signs that require medical attention?
- What should I do if I experience mood changes, restlessness, or worsening depression while taking Zurzuvae?
- Are there any precautions I should take if I’m pregnant, planning to become pregnant, or breastfeeding?
- How should I adjust my daily routine to accommodate potential drowsiness or impaired alertness?
- Are there any lifestyle changes or dietary considerations that might help manage side effects more effectively?
- Can you provide recommendations for alternative treatments or therapies if Zurzuvae’s side effects become problematic for me?
In My Experience
In my experience, I believe Zurzuvae will serve as a great new addition for the treatment of postpartum depression. PPD is a very tough condition to manage with few conventional options and no options previously that didn’t require constant visits to a clinic or provider to receive treatment.
I think it will be a huge benefit for mothers with this condition if they are able to take Zurzuvae for 14 days and see real tangible benefits to their PPD with an oral medication they can take from the comfort of their own home. This will make a huge difference for new mothers that will already undoubtedly be busy, and I hope I continue to see good news about the medication as it begins to hopefully become more prevalent in practice.
Additional Resources
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