Zuranolone
Postpartum Depression
.svg)
Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
NO
Pharmaceutical Class
Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Controlled Drug Substance
No
Zuranolone
Summary
Zuranolone is used to treat postpartum depression (PPD) in adult women. PPD is a type of depression that occurs after childbirth.
Zuranolone works by modulating GABAA receptors in the brain. This helps to stabilize mood and reduce symptoms of depression.
The usual daily dose of Zuranolone for adults is 50 mg, taken orally once daily in the evening for 14 days. It should be taken with fat-containing food.
Common side effects of Zuranolone include somnolence (36%), dizziness (13%), diarrhea (6%), and fatigue (5%). Serious adverse effects can include suicidal thoughts, confusion, and CNS depression.
Zuranolone can cause drowsiness, dizziness, and confusion which can impair driving. It may also cause suicidal thoughts, especially in young adults. Avoid alcohol and other CNS depressants during treatment. It should not be used in children.
Indications and Purpose
How does Zuranolone work?
Zuranolone acts as a positive allosteric modulator of GABAA receptors in the brain. This modulation enhances the inhibitory effects of GABA, a neurotransmitter, which helps to stabilize mood and reduce symptoms of depression. Its exact mechanism in treating postpartum depression is not fully understood but is believed to involve these pathways.
Is Zuranolone effective?
Zuranolone has been shown to be effective in treating postpartum depression (PPD) in adults through clinical studies. In these studies, patients taking Zuranolone experienced a statistically significant improvement in depressive symptoms compared to those taking a placebo. The primary endpoint was the change from baseline in depressive symptoms as measured by the HAMD-17 total score at Day 15.
What is Zuranolone?
Zuranolone is used to treat postpartum depression in adult women. It belongs to a class of medications called neurosteroid antidepressants and works by modulating GABAA receptors in the brain, which helps to alleviate depressive symptoms. It is taken once daily in the evening with fat-containing food for a 14-day course.
Directions for Use
For how long do I take Zuranolone?
The typical duration of use for Zuranolone is 14 days. It is taken once daily in the evening with fat-containing food. The safety and effectiveness of using Zuranolone beyond this 14-day treatment course have not been established.
How do I take Zuranolone?
Zuranolone should be taken once daily in the evening with fat-containing food, such as a meal with 400 to 1,000 calories and 25% to 50% fat. This helps with the absorption of the medication. There are no specific food restrictions, but it is important to follow your doctor's instructions regarding diet while on this medication.
How long does it take for Zuranolone to start working?
Zuranolone typically starts to show effects within a few days of starting treatment. In clinical studies, significant improvements in depressive symptoms were observed by Day 15. However, individual responses may vary, and it is important to complete the full 14-day course as prescribed by your doctor.
How should I store Zuranolone?
Zuranolone should be stored at room temperature, between 68°F to 77°F (20°C to 25°C). It should be kept in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom to prevent exposure to excess heat and moisture. Unneeded medication should be disposed of through a take-back program, not flushed down the toilet.
What is the usual dose of Zuranolone?
The usual daily dose of Zuranolone for adults is 50 mg taken orally once daily in the evening for 14 days. It should be taken with fat-containing food. Zuranolone is not approved for use in children, so there is no recommended dose for pediatric patients.
Warnings and Precautions
Can I take Zuranolone with other prescription drugs?
Zuranolone can interact with CNS depressants like alcohol, benzodiazepines, and opioids, increasing the risk of drowsiness and respiratory depression. It also interacts with strong CYP3A4 inhibitors, which can increase Zuranolone levels and side effects. Avoid using Zuranolone with CYP3A4 inducers, as they can reduce its effectiveness. Always consult your doctor about any medications you are taking.
Can Zuranolone be taken safely while breastfeeding?
Zuranolone is present in low levels in human milk, but its effects on a breastfed infant are unknown. The decision to continue breastfeeding while on Zuranolone should consider the benefits of breastfeeding, the mother's need for the medication, and any potential risks to the infant. Consult your healthcare provider for personalized advice.
Can Zuranolone be taken safely while pregnant?
Zuranolone may cause fetal harm based on animal studies, and its use during pregnancy is not recommended unless absolutely necessary. Women of reproductive potential should use effective contraception during treatment and for one week after the final dose. There is a pregnancy exposure registry to monitor outcomes, but there is no strong evidence from human studies on fetal harm.
Is it safe to drink alcohol while taking Zuranolone?
Drinking alcohol while taking Zuranolone can increase the risk of serious side effects such as drowsiness, dizziness, and confusion. It is advised not to drink alcohol during treatment with Zuranolone without consulting your doctor, as it can enhance the central nervous system depressant effects of the medication.
Is it safe to exercise while taking Zuranolone?
Zuranolone may cause drowsiness, dizziness, and confusion, which could potentially limit your ability to exercise safely. If you experience these symptoms, it is advisable to avoid engaging in physical activities that require full alertness and coordination. Consult your doctor for personalized advice on exercising while taking Zuranolone.
Who should avoid taking Zuranolone?
Important warnings for Zuranolone include its potential to cause drowsiness, dizziness, and confusion, which can impair driving and increase the risk of falls. It may also cause suicidal thoughts, especially in young adults. Avoid alcohol and other CNS depressants during treatment. There are no specific contraindications, but caution is advised for those with liver or kidney issues, and it should not be used in children.
