1. Introduction
Version followed: US prescribing information for ZURZUVAE (zuranolone) capsules, revised 4/2026, and ZULRESSO (brexanolone) injection, revised 6/2022; EU (EMA EPAR, authorised 17 September 2025) and UK (MHRA approval, 27 August 2025) status for zuranolone; NICE CG192 (last updated 11 February 2020) for the perinatal mental health care pathway. Product status checked as of October 2026 against the sources listed.
These are prescription medicines, not psychotherapies. A psychotherapist does not prescribe, deliver or adjust them. This guide is written for the psychotherapist working alongside the prescriber or perinatal mental health team: what the treatments are as official labelling describes them, and what you do before, during and after them.
- What they are. Brexanolone (ZULRESSO) and zuranolone (ZURZUVAE) are neuroactive steroid medicines licensed specifically for postpartum depression (PPD). The US labels describe them as acting on the GABA system (the brexanolone label refers to "similar GABAergic drugs"); the zuranolone label notes it does not directly affect monoaminergic systems, unlike conventional antidepressants. [source: ZULRESSO PI 6/2022; ZURZUVAE PI 4/2026] Detailed receptor pharmacology was not extracted from the labels and is not described further here [uncertain].
- Formulations and settings. Brexanolone is an intravenous infusion given only in an enrolled healthcare facility under a REMS programme; its maker stated it would be commercially available in the US only until 31 December 2024, after uptake of the oral alternative [source: Sage Therapeutics press release, 29 Oct 2024]. Zuranolone is an oral capsule taken as a short, time-limited course at home in the US, and in the UK is to be prescribed under the supervision of a specialist team [source: ZURZUVAE PI; MHRA press release].
- Regulatory status (as sources state it). FDA approved brexanolone in 2019 and zuranolone on 4 August 2023 (the first oral PPD treatment) [source: Psychiatric Times, 4 Aug 2023, citing the FDA news release; the FDA release itself [uncertain]]. ZULRESSO: PPD in patients 15 years and older. ZURZUVAE (US): PPD in adults. EU: PPD in adults following childbirth, under additional monitoring, marketing authorisation holder Biogen Netherlands B.V. [source: EMA EPAR]. UK: moderate or severe postnatal depression in adults following childbirth, granted to Biogen [source: MHRA]. NICE draft guidance (August 2025) did not recommend zuranolone for NHS use; the final NICE decision is not confirmed [uncertain]. Both are US Schedule IV controlled substances [source: both PIs].
- Core idea of how change happens (for your work). The medicine is intended to reduce depressive symptoms quickly over a short course; your part is to make sure the person reaches perinatal psychiatric assessment, can make an informed choice, can take the treatment safely around infant care and driving, is monitored for warning signs, and has continuing psychological care because the course is short and long-term benefit is uncertain [source: NICE draft guidance GID-TA11356 notes follow-up only to day 45 in trials] [synthesis].
For ketamine-assisted psychotherapy and psychedelic-assisted therapy, see Domain VII; these are different treatments and not covered here.
2. Framework
There is no manualised psychotherapy framework for these medicines. The phases below are a care pathway built from NICE CG192, the product labelling and regulator statements; how they translate into therapy sessions is [synthesis].
Phase A: Recognition and referral (in your ongoing therapy).
- Goal: recognise moderate to severe postpartum depression, suicide risk, or possible psychosis, and get the person to the right medical assessment.
- NICE: refer any woman with, or suspected of having, a severe mental illness (or history of one) to secondary care, preferably a specialist perinatal service (rec. 1.5.10); assess for treatment within 2 weeks of referral and provide psychological interventions within 1 month of initial assessment (rec. 1.7.3). [source: NICE CG192]
- Move on when: a referral has been made and the client has a named prescriber or team.
Phase B: Prescriber assessment and shared decision (1-3 therapy sessions alongside) [synthesis].
- Goal: support the client to understand options presented by the prescriber (antidepressants, high-intensity psychological therapy such as CBT, neurosteroid treatment where available and appropriate) and to decide.
- ACOG has issued a 2026 Clinical Practice Update on brexanolone and zuranolone for PPD with onset in the third trimester or within 4 weeks postpartum, updating Clinical Practice Guideline No. 5 (2023) and replacing the August 2023 Practice Advisory; its specific recommendations are not reported here [uncertain]. [source: SMFM/OPQIC listings of the ACOG update]
- Move on when: the client has decided with the prescriber whether to proceed.
Phase C: Practical planning before the course (1-2 sessions) [synthesis based on labelling].
- Goal: plan childcare, transport, supervision during infant care, feeding decisions with the prescriber, contraception questions routed to the prescriber, alcohol and other sedatives discussed with the prescriber, and a written safety plan.
- Move on when: plan in place before the first dose.
Phase D: During the course (brief check-ins; frequency agreed with the team) [synthesis].
- Goal: support, monitor for warning signs named in labelling, pass concerns to the prescriber, keep psychological work light and supportive while sedation may affect concentration.
- Move on when: the course ends.
Phase E: After the course (ongoing therapy).
- Goal: monitor for return of symptoms, consolidate psychological treatment (NICE rec. 1.8.3: consider a high-intensity psychological intervention such as CBT for moderate or severe depression), plan for relapse, coordinate with the prescriber. [source: NICE CG192]
Format: individual sessions (in person, video or phone); joint sessions with partner or family with consent (NICE rec. 1.3.2). Session count is set by your usual treatment, not by the medicine [synthesis].
3. Guiding principles
- Prescriber owns the medicine. You never advise starting, stopping, changing, or combining any medicine; every medication question goes to the prescriber or pharmacist. [synthesis, consistent with labelling directing decisions to the clinician]
- Label-accurate information only. Describe risks and benefits as the official labelling and regulators state them, and give the client the Medication Guide or patient leaflet rather than your own summary. [source: ZURZUVAE PI, Medication Guide]
- Infant safety comes first. Sedation can impair caregiving; plan supervision of infant care and driving before treatment begins. [source: ZULRESSO PI requires accompaniment during interactions with children; ZURZUVAE boxed warning; NICE draft guidance stakeholder concerns]
- Risk assessment is continuous. Both labels carry suicidal thoughts and behaviours warnings; NICE asks for perinatal risk assessment covering self-harm, suicide and risks to others including the baby. [source: both PIs; NICE CG192 rec. 1.6.3]
- Postpartum psychosis is an emergency, not a depression subtype to manage in therapy. Sudden-onset psychotic symptoms need immediate assessment (within 4 hours of referral, per NICE). [source: NICE CG192 rec. 1.5.12]
- The woman decides. NICE asks clinicians to acknowledge her central role, discuss uncertainty, use absolute numbers and decision aids. [source: NICE CG192 rec. 1.4.6-1.4.7]
- Involve family with consent. Partners and family are central to planning childcare and noticing warning signs. [source: NICE CG192 rec. 1.3.2, 1.4.3]
- Medicine plus psychotherapy, not instead of. The course is short and trials followed people only to day 45; continuing psychological care covers the period after. [source: NICE draft guidance] [synthesis for the implication]
- Availability varies by country and over time. Check status before discussing: brexanolone was withdrawn commercially in the US at end-2024; zuranolone access in the NHS depends on NICE and local commissioning. [source: Sage 2024; NICE draft guidance] [uncertain on current NHS access]
- Respect feeding choices. Give breastfeeding information only as labelling states and route decisions to the prescriber; NICE asks clinicians to support the woman's choice of feeding method. [source: NICE CG192 rec. 1.9.8; PIs]
4. Intervention inventory
Part A describes how the treatments are delivered, at a descriptive level and as labelling states it, so you can talk accurately with clients and teams. Part B is your own work as the psychotherapist. No doses, infusion details, schedules or combinations are given; those belong to the prescriber.
Part A1. Brexanolone (ZULRESSO) as labelled (US; commercially discontinued)
- Purpose / when relevant: Mainly for clients who received it before 2025 or who ask about it. Its maker stated it would be commercially available in the US until 31 December 2024 [source: Sage press release 29 Oct 2024]. Current availability elsewhere was not found [uncertain].
- How it is delivered (descriptive): Continuous intravenous infusion in a healthcare facility enrolled in the ZULRESSO REMS. Indication: PPD in patients 15 years and older. [source: ZULRESSO PI 6/2022]
- Boxed warning: Excessive sedation and sudden loss of consciousness; patients must be monitored with continuous pulse oximetry, and the medicine is available only through a restricted programme. Some patients lost consciousness without prior sedation; consciousness typically returned after the infusion was interrupted. [source: ZULRESSO PI]
- REMS requirements (as labelled): enrolled healthcare facilities; certified pharmacies; patients enrolled before treatment; registered wholesalers. A healthcare provider must be on site throughout; patients are assessed for sedation at set intervals while awake; patients "must be accompanied during interactions with their child(ren)" and must not be the primary caregiver for dependants during the infusion. [source: ZULRESSO PI]
- Other warnings: suicidal thoughts and behaviours (reassess treatment if depression worsens or suicidality emerges); increased sedation with other CNS depressants such as opioids, benzodiazepines, alcohol. Counselling: no driving or hazardous activity until sleepiness has fully resolved; no alcohol during treatment. Most common adverse reactions: sedation or somnolence, dry mouth, loss of consciousness, flushing. Schedule IV; potential for abuse and dependence. [source: ZULRESSO PI]
- Lactation (as labelled): passes into breast milk at a low relative infant dose with minimal expected infant oral absorption; benefits of breastfeeding and maternal need are to be weighed against possible infant effects. [source: ZULRESSO PI]
- Pregnancy (as labelled): may cause fetal harm based on animal data with similar GABAergic drugs; human data insufficient; a US pregnancy registry for antidepressants exists. [source: ZULRESSO PI]
Part A2. Zuranolone (ZURZUVAE) as labelled in the US
- Purpose / when relevant: Clients in the US with PPD whose prescriber is considering or has started it.
- How it is delivered (descriptive): Oral capsule taken by the patient at home as a short, fixed, time-limited course; the prescriber and Medication Guide give the timing and food instructions. Indication: PPD in adults; not established in paediatric patients. No contraindications listed. No REMS was described in the label extract [uncertain]. [source: ZURZUVAE PI 4/2026]
- Boxed warning: impaired ability to drive or engage in other potentially hazardous activities. It causes driving impairment due to CNS depressant effects; patients should not drive or do other hazardous activities for at least 12 hours after each dose throughout the course, and may not be able to judge their own impairment. Simulation studies showed impairment including the next morning. [source: ZURZUVAE PI]
- Warnings and precautions: CNS depressant effects (somnolence, confusion, dizziness, gait problems, possible falls; serious confusional states reported); suicidal thoughts and behaviours (antidepressant class warning; increased risk in people 24 and younger; monitor for worsening and emergent suicidality); embryo-fetal toxicity. [source: ZURZUVAE PI]
- Interactions in general terms: alcohol and other CNS depressants (labelled examples include benzodiazepines, opioids, tricyclic antidepressants) can increase sedation and psychomotor impairment; some liver-enzyme (CYP3A4) interacting medicines change exposure. These are prescriber matters. [source: ZURZUVAE PI]
- Common adverse reactions: somnolence, dizziness, diarrhoea, fatigue, urinary tract infection, nasopharyngitis; somnolence was the most common reason for discontinuation in trials. [source: ZURZUVAE PI]
- Lactation (as labelled): present at low levels in human milk; no data on effects in breastfed infants; clinicians weigh benefits of breastfeeding against maternal need and possible risks to the child. [source: ZURZUVAE PI]
- Pregnancy and contraception (as labelled): animal data suggest fetal harm; effective contraception is advised during treatment and for one week after the final dose; National Pregnancy Registry for Antidepressants. [source: ZURZUVAE PI]
- Abuse and dependence: Schedule IV; abuse potential; physical dependence possible, with withdrawal-type effects reported after stopping in healthy subjects. Medication Guide: keep it secure and away from children, do not share. [source: ZURZUVAE PI]
Part A3. Zuranolone in the EU and UK
- EU: authorised 17 September 2025 for PPD in adults following childbirth; must not be taken during pregnancy; most common side effects sleepiness, dizziness, drowsiness; under additional monitoring. The full SmPC (driving, breastfeeding wording, risk-minimisation measures) is not drawn on [uncertain]. [source: EMA EPAR]
- UK: MHRA approved 27 August 2025 for moderate or severe postnatal depression in adults following childbirth; contraindicated in pregnancy; contraception during and for one week after; warnings on sedation and driving, suicidal behaviour and withdrawal reactions; to be prescribed "under the supervision of a specialist team in an appropriate setting"; report side effects via Yellow Card. [source: MHRA press release]
- NHS access: NICE draft guidance (August 2025) said zuranolone should not be used for postnatal depression in adults, pending further committee work; it expected use to be in secondary perinatal mental health services, and recorded stakeholder concerns about sedation affecting caregiving, dependence, repeat courses, and that safety in breastfeeding had not been established. Final outcome not confirmed [uncertain]. [source: NICE GID-TA11356 draft guidance]
- Who prescribes: a prescriber (in the UK, a specialist team per MHRA; in the US, a prescriber; specialist requirements were not stated in the label extract) [source: MHRA; ZURZUVAE PI] [uncertain for the US].
Part B. The psychotherapist's interventions
All of Part B is [synthesis] built on the labelling and NICE CG192 cited, unless a source is tagged.
B1. Recognising when to suggest a medical review
- Purpose / when to use: Any perinatal client whose depression is moderate to severe, worsening, not responding to therapy, or accompanied by suicidal thoughts, inability to care for self or baby, or psychotic features.
- Steps: (1) Screen routinely for mood, sleep beyond infant waking, functioning, bonding, intrusive thoughts and suicidality using your service's validated measure. (2) Ask about prior severe mental illness, bipolar disorder and family history of perinatal psychiatric illness (NICE rec. 1.5.11). (3) If thresholds are met, raise a medical review with the client in the same session. (4) Document and agree who makes the referral.
- Example language (illustrative): "What you're describing sounds like more than I can help with by talking alone. I'd like you to see a perinatal psychiatrist who can go through all the treatment options with you, including medicines."
- Watch for: minimisation driven by fear of child-protection involvement; partners describing more severe symptoms than the client reports.
B2. Referral to perinatal psychiatry and collaborative care
- Purpose / when to use: To get a prescriber assessment and coordinated care. NICE: refer severe or suspected severe illness to secondary care, preferably specialist perinatal services (rec. 1.5.10); inpatient care in the first 12 months after birth normally in a mother and baby unit (rec. 1.10.1). [source: NICE CG192]
- Steps: (1) Obtain consent to share information. (2) Send a referral naming symptoms, risks, onset relative to birth or late pregnancy, current medicines the client reports, feeding method and supports. (3) Agree a communication route with the prescriber (who to contact about side effects or risk, and how fast). (4) Confirm the appointment and follow up if it does not happen.
- Example language (illustrative): "With your permission I'll write to the perinatal team and tell them what we've talked about, so you don't have to repeat everything."
- Watch for: referral loss in transitions between maternity, primary care and mental health services; delays exceeding NICE's 2-week assessment expectation (rec. 1.7.3).
B3. Psychoeducation about neurosteroid treatment
- Purpose / when to use: When the client asks about these medicines or the prescriber has mentioned them.
- Steps: (1) Ask what the client already knows and has read online. (2) Correct misinformation using the official Medication Guide or patient leaflet, ideally reading it together. (3) Cover in plain words: it is a specific PPD treatment; the oral form is a short course; the main labelled risks are sleepiness, impaired driving, suicidality warnings, harm in pregnancy, and dependence potential; availability depends on country. (4) Write the client's questions down for the prescriber. (5) Do not offer opinions on whether it is right for her.
- Example language (illustrative): "The official leaflet says the most important thing to know is that it can make you too sleepy to drive safely, even if you feel fine. Let's look at what it says together and list questions for your psychiatrist."
- Watch for: unrealistic expectations of a cure after a short course; fear driven by the boxed warning that blocks a balanced discussion.
B4. Supporting informed consent and shared decision-making
- Purpose / when to use: Before and after the prescriber appointment where options are presented.
- Steps: (1) Help the client clarify her values (speed of relief, breastfeeding, driving needs, contraception, preference for medicine or therapy). (2) Use NICE's discussion points: likely benefits, uncertainty, risks of no treatment, risks of each option (rec. 1.4.6). (3) Encourage her to ask the prescriber for absolute numbers and a decision aid (rec. 1.4.7). (4) Check understanding with teach-back. (5) If she is too unwell to weigh information, tell the prescriber; capacity assessment is the medical team's role.
- Example language (illustrative): "It's your decision. What matters most to you about how you get better? Let's make sure your psychiatrist hears that."
- Watch for: coercion by others (family pressure for or against medication); consent given without understanding the driving and childcare implications.
B5. Practical planning around treatment (driving, childcare, infant safety)
- Purpose / when to use: Before an oral course begins; for brexanolone (historic or elsewhere), before admission.
- Steps: (1) Map the client's daily driving and hazardous tasks (school runs, work, using machinery). (2) Plan alternatives for the whole course, based on the boxed warning that she should not drive for at least 12 hours after each dose and may not judge her own impairment. (3) Plan who will be present for infant care while she may be sleepy, including night feeds, bathing and carrying the baby on stairs, given labelled somnolence, dizziness, confusion and fall risk. (4) Agree safe storage of the capsules away from children (Medication Guide). (5) Note alcohol: labelling advises avoiding it; encourage her to discuss other sedating medicines with her prescriber. (6) Write the plan down and share with partner/family with consent.
- Example language (illustrative): "The leaflet is clear that you shouldn't drive for a while after each dose, even if you feel alert. Who could take over the driving and stay nearby while you're with the baby during this time?"
- Watch for: lack of any support person (raise with the prescriber before treatment begins); single parents; shift-working partners. [source for warnings: ZURZUVAE PI; ZULRESSO PI]
B6. Breastfeeding conversations (labelling only)
- Purpose / when to use: When the client is breastfeeding or expressing milk and is considering treatment.
- Steps: (1) Give only what the label states: for zuranolone, low levels in milk and no data on infant effects, with the clinician weighing benefits against risks; in the UK, NICE stakeholders noted safety in breastfeeding had not been established. (2) Refer feeding decisions to the prescriber and, if available, an infant-feeding or lactation specialist. (3) Explore the emotional meaning of feeding choices without steering. (4) Support whatever she decides (NICE rec. 1.9.8).
- Example language (illustrative): "The leaflet says there's very little information on babies. That's a question your psychiatrist and the infant-feeding team can go through with you. How are you feeling about feeding in general?"
- Watch for: guilt and shame about feeding decisions; worsening mood if feeding is disrupted.
B7. Pregnancy and contraception routing
- Purpose / when to use: Any client who could become pregnant during or soon after a zuranolone course.
- Steps: (1) Note that US, EU and UK labelling warn of fetal harm (EU and UK: contraindicated in pregnancy) and advise contraception during and for one week after. (2) Prompt her to raise contraception with her prescriber or GP. (3) If she discloses possible pregnancy, advise her to contact the prescriber promptly. [source: ZURZUVAE PI; MHRA; EMA]
- Example language (illustrative): "The leaflet mentions contraception. Has your doctor talked that through with you?"
- Watch for: discomfort talking about sex and contraception after birth.
B8. Monitoring and passing on side effects and warning signs
- Purpose / when to use: Throughout the course and in the weeks after.
- Steps: (1) At each contact ask briefly about sleepiness, confusion, dizziness, falls, mood, suicidal thoughts, and any driving that happened. (2) Ask the partner or support person, with consent, what they have noticed. (3) Pass any labelled warning sign (worsening depression, emergent suicidality, confusion, excessive sedation, falls, unusual behaviour) to the prescriber the same day; urgent risk goes to emergency services. (4) Remind the client that she or you can report suspected side effects (US: FDA MedWatch per the Medication Guide; UK: Yellow Card per MHRA). (5) Record what you passed on and to whom.
- Example language (illustrative): "You sound much more muddled today than usual. I'd like to ring your psychiatrist now, with you here, to let them know."
- Watch for: sedation in session (slowed speech, losing track); new withdrawal-type symptoms after a course (the label reports insomnia, palpitations, nausea and paranoia after stopping in healthy subjects) to pass on, not interpret. [source: ZURZUVAE PI; MHRA]
B9. Conversations about adherence and ambivalence (never advising a change)
- Purpose / when to use: The client is unsure about taking the medicine, has missed doses, wants to stop, or wants to take more.
- Steps: (1) Explore the ambivalence with open questions and reflections (both sides). (2) Do not recommend continuing, stopping or adjusting. (3) Ask her to contact the prescriber before making any change; offer to help her prepare what she will say. (4) If she discloses taking extra capsules, sharing them, or combining with alcohol or other sedatives, treat it as a safety issue: check her immediate state and contact the prescriber, poison service or emergency services as needed.
- Example language (illustrative): "Part of you wants to feel better quickly, and part of you worries about being drowsy with the baby. Both make sense. That's exactly the conversation to have with your psychiatrist before you decide anything."
- Watch for: your own views about medication leaking into your reflections; pressure from relatives.
B10. Suicide risk assessment and safety planning
- Purpose / when to use: At assessment, before, during and after the course. Both labels carry suicidal thoughts and behaviours warnings, and NICE requires perinatal risk assessment including risks to the baby. [source: PIs; NICE CG192 rec. 1.6.3, 1.6.5]
- Steps: (1) Ask directly about suicidal thoughts, plans, intent, and thoughts of harming the baby, distinguishing intrusive unwanted thoughts from intent. (2) Follow your service's risk-assessment procedure. (3) Build a written safety plan: warning signs, coping steps, people to contact, professional and crisis numbers, and lethal-means counselling (secure storage of medicines, including the zuranolone supply, held by another adult if risk is raised; removal of other means). (4) Share the plan with the prescriber and, with consent, family. (5) Escalate same day if risk rises; inform relevant professionals (NICE rec. 1.6.5).
- Example language (illustrative): "Sometimes when people feel this low they have thoughts of ending their life, or frightening thoughts about the baby. Have you had any thoughts like that?"
- Watch for: sudden calm after distress; hopelessness; social withdrawal; partners reporting talk of being a burden.
B11. Recognising postpartum psychosis and emergency referral
- Purpose / when to use: Any sign of sudden-onset psychotic or manic symptoms, especially in the first 2 weeks after birth, or in clients with severe mental illness or a first-degree relative with severe perinatal illness. [source: NICE CG192 rec. 1.5.11]
- Steps: (1) Note symptoms such as confusion, disordered thinking, unusual beliefs (including about the baby), hallucinations, marked agitation or elation, or severe insomnia. (2) Treat as a psychiatric emergency: arrange immediate assessment by secondary or specialist perinatal services (NICE: within 4 hours of referral, rec. 1.5.12) or emergency services. (3) Do not leave her alone with the baby if safety is in doubt; contact a support person. (4) Do not attempt to manage it in psychotherapy. (5) Tell the prescriber; confusional states on zuranolone also need urgent medical review because the label reports serious confusional states. [source: ZURZUVAE PI]
- Example language (illustrative): "I'm worried about what you're experiencing and I want a doctor to see you today. I'm going to call them now and ask your partner to come."
- Watch for: rapid fluctuation; families normalising symptoms as exhaustion.
B12. Infant safeguarding
- Purpose / when to use: When maternal illness, sedation or risk could affect the baby's or other dependants' safety.
- Steps: (1) Include the baby and other dependants in every risk assessment (NICE rec. 1.3.4, 1.6.3). (2) Plan supervision during periods of sedation (B5). (3) Follow local safeguarding protocols where there is concern about maltreatment (rec. 1.6.4). (4) Be transparent with the client about when you would share concerns. (5) Frame safeguarding as protecting the family, which reduces fear-driven concealment.
- Example language (illustrative): "My job is to help you and your baby be safe. If I ever had to share a worry, I would tell you first wherever I could."
- Watch for: fear of losing custody leading to hidden symptoms.
B13. Integrating psychotherapy before, during and after the course
- Purpose / when to use: All clients receiving or considering neurosteroid treatment.
- Steps: (1) Before: continue or start evidence-based therapy; NICE advises considering a high-intensity psychological intervention such as CBT for moderate or severe depression (rec. 1.8.3). (2) During: shorter, supportive, practical sessions; avoid heavy cognitive tasks or emotionally intense work when the client is sedated; focus on sleep protection, support, monitoring. (3) After: resume full therapy; address relationship, attachment and bonding, role transition, trauma related to birth, and relapse prevention. (4) Keep the prescriber informed of progress.
- Example language (illustrative): "While you're on the medicine we'll keep sessions shorter and practical. Afterwards we'll get back to the work on what led here and how to stay well."
- Watch for: the client dropping out of therapy once mood lifts; attributing all change to the medicine.
B14. Support after the course ends and relapse planning
- Purpose / when to use: In the weeks and months after a course; long-term benefit is uncertain because trial follow-up ended at day 45. [source: NICE draft guidance]
- Steps: (1) Agree measures to track mood regularly. (2) Write a relapse signature with the client and family (early signs, actions, contacts). (3) Make sure she knows how to reach the prescriber quickly if symptoms return; questions about repeat treatment go to the prescriber. (4) Plan for future pregnancies: NICE suggests preconception counselling for women with current or past severe mental illness (rec. 1.4.2).
- Example language (illustrative): "Let's write down what the first signs of feeling worse would look like for you, and exactly who you'll contact."
- Watch for: symptom return as the course effect fades; discouragement if improvement was partial.
5. Handling problems
The sources do not address psychotherapy problems directly; everything below is [synthesis] unless tagged.
- Client asks you whether she should take it, or stop it. Say plainly this is a decision for her and her prescriber; offer to help her prepare questions and clarify her values (B4, B9). Illustrative: "I can't advise on the medicine itself, but I can help you work out what you want to ask."
- Client wants to keep driving during the course. Restate the boxed warning (she may not be able to judge her own impairment) [source: ZURZUVAE PI]; problem-solve transport; if she says she will drive anyway, tell the prescriber and document. Do not threaten or moralise.
- No one available to help with infant care. Raise with the prescriber before treatment begins; explore family, health visitor or community supports; this may change the prescriber's plan, which is their decision.
- Medicine not available or not funded (e.g. NHS, or brexanolone after 2024). Validate disappointment; refocus on available options through the perinatal team (antidepressants, high-intensity psychological therapy per NICE CG192). [source: Sage 2024; NICE draft guidance]
- Overwhelm or sedation in session. Shorten the session, check safety and who is with the baby, avoid heavy emotional work, and inform the prescriber if sedation is marked or new (B8).
- Stuck after the course (partial or no response, or relapse). Return to the prescriber for review; intensify psychotherapy; reassess for bipolar features, trauma, relationship stress, sleep deprivation and physical causes the medical team should check.
- Non-adherence (missed doses, extra doses, sharing). Explore without judgement; route dosing questions to the prescriber; treat extra doses or combining with alcohol or other sedatives as a safety issue (B9). The Medication Guide advises poison help or emergency care for overdose. [source: ZURZUVAE PI]
- Fear of child protection blocks disclosure. Explain the limits of confidentiality early and calmly; frame safeguarding as support (B12).
- Rupture: client feels pushed toward or away from medication. Name it, apologise for any pressure she felt, reaffirm that the decision is hers and the prescriber's, and return to her goals.
- Family pressure (for or against medicine). With consent, hold a joint session to share label-based information and the safety plan; keep the client's choice central (NICE rec. 1.3.2, 1.4.7).
- Breastfeeding conflict. Give labelling information only, refer to prescriber and infant-feeding support, and work on guilt or grief about feeding choices (B6).
- Signs of psychosis, confusion or acute suicidality. Stop the therapeutic agenda and follow B10 and B11 immediately.
- Concern about misuse or dependence (Schedule IV). Ask about substance use history, encourage the client to be open with the prescriber, and pass on concerns; NICE stakeholders and the label both note dependence potential. [source: ZURZUVAE PI; NICE draft guidance]
- Possible pregnancy during treatment. Encourage immediate contact with the prescriber; support her through uncertainty (B7).
- Information overload from online sources. Use the official Medication Guide or patient leaflet as the shared reference; keep a question list for the prescriber.
Sources
Sources:
- ZULRESSO (brexanolone) injection, US prescribing information, revised 6/2022 (FDA accessdata)
- Zurzuvae (zuranolone) prescribing information, revised 4/2026 (Drugs.com reproduction of US label)
- EMA: Zurzuvae EPAR
- MHRA press release: MHRA approves zuranolone to treat postnatal depression in adults following childbirth (27 August 2025)
- NICE CG192: Antenatal and postnatal mental health: clinical management and service guidance (last updated 11 February 2020)
- NICE GID-TA11356 (zuranolone, postnatal depression): draft guidance (August 2025)
- Sage Therapeutics third-quarter 2024 results press release (Business Wire, 29 October 2024)
- Psychiatric Times: FDA approves first oral treatment for postpartum depression in adults (4 August 2023)
- MGH Center for Women's Mental Health (Nonacs R.): How worrisome is the boxed warning for the new postpartum depression medication? (23 January 2024)
- SMFM listing: ACOG Clinical Practice Update: Zuranolone for the Treatment of Postpartum Depression (2026; abstract only)
- OPQIC listing: ACOG Zuranolone and Brexanolone for the Treatment of Postpartum Depression (abstract only)
Further reading (not drawn on) [uncertain]: FDA news release on zuranolone approval (4 August 2023); EU Zurzuvae summary of product characteristics; ACOG Clinical Practice Guideline No. 5, Treatment and Management of Mental Health Conditions During Pregnancy and Postpartum, Obstet Gynecol 2023;141:1262-88 (cited as given in the ACOG update abstract); final NICE technology appraisal decision on zuranolone.