MHRA approves zuranolone to treat postnatal depression in adults following childbirth
Source: gov.uk (2025-08-27)

As with any medicine, the MHRA will keep the safety of zuranolone under close review.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved zuranolone (brand name: Zurzuvae) to treat moderate or severe postnatal depression (PND) in adults following childbirth.

Postnatal depression is a type of depression that many parents experience after having a baby. It is a common problem, affecting more than 1 in every 10 women within a year of giving birth.

Common symptoms of PND include persistent feelings of sadness or inadequacy, irritability, anxiety about their baby’s wellbeing, and loss of interest in previously enjoyable activities, accompanied by physical manifestations such as extreme fatigue, disrupted sleep patterns, and changes in appetite.

Zuranolone is the first oral treatment for postnatal depression approved in the UK.

The MHRA conducted a rigorous assessment of the safety, quality, and efficacy of zuranolone.

Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:

“Keeping patients safe and enabling their access to high quality, acceptably safe, and effective medicines are key priorities for us.

“The approval of zuranolone reflects our ongoing commitment to increasing access to new medicines that have the potential to make a real difference to people suffering from serious health issues, and that have proven safety, quality and efficacy recognised by comparable international regulators.

“We are assured that the appropriate regulatory standards for the approval of this medicine have been met.

“As with all products, we will keep the safety of zuranolone under close review.”

Zuranolone comes as a capsule and is taken orally, at night with a fat-containing meal for 14 days.

The most common side effects for zuranolone include memory impairment, confusion, somnolence (drowsiness), dizziness, sedation, tremor, diarrhoea, and fatigue. The product information contains important warnings about the risk of suicidal behaviour and withdrawal reactions as well as its sedative properties affecting the ability to drive. These sedative properties must be taken into account when prescribing to a new mother and it is important that this medication is prescribed under the supervision of a specialist team in an appropriate setting.

Zuranolone may cause fetal harm and is contraindicated during pregnancy. Women should use effective contraception while taking, and for one week after taking the medicine.

A full list of side effects can be found in the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SmPC), available on the MHRA website within 7 days of approval.

As with any medicine, the MHRA will keep the safety of zuranolone under close review and a further safety study is planned.

Anyone who is prescribed this medicine in the future and suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Notes to editors

The approval was granted on 27 August 2025 to Biogen.

This product was submitted and approved via the International Recognition Procedure (IRP). (https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure)

More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website (https://products.mhra.gov.uk/) within 7 days of approval.

For more information about postnatal depression, please visit: Postnatal depression - NHS (https://www.nhs.uk/mental-health/conditions/post-natal-depression/overview/)

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

The MHRA is an executive agency of the Department of Health and Social Care.

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