Ketamine and esketamine

1. Introduction

Version followed: for esketamine, the US SPRAVATO (esketamine) nasal spray Prescribing Information and Medication Guide (Medication Guide revised 09/2026; prescribing information revised 3/2026 as shown on Drugs.com) and the EU Summary of Product Characteristics (EMA, first authorised 18 December 2019, renewed 22 August 2024); for racemic ketamine, the FDA statement on compounded ketamine (10 October 2023) and the APA Council of Research task force consensus statement on off-label ketamine (Sanacora et al., JAMA Psychiatry, 2017, as reported by MDedge). Status checked October 2026.

This is a prescriber-delivered medicine, not a psychotherapy. This guide is written for the psychotherapist working alongside the prescriber and treatment team. It contains no doses, schedules, combinations or preparation details; those belong to the prescriber and the official labelling. Ketamine-assisted psychotherapy (KAP), where the drug experience is used inside a structured psychotherapy, is a psychotherapy and is covered in Domain VII; this entry only cross-refers to it.

Two products are involved, and their status differs sharply [source: Drugs.com Spravato PI; FDA 2023 compounded ketamine statement]:

Esketamine nasal spray (Spravato) is an approved antidepressant medicine. In the US it is indicated for adults with treatment-resistant depression (alone or with an oral antidepressant) and, with an oral antidepressant, for depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behaviour. The label states it has not been shown to prevent suicide or reduce suicidal ideation, and does not replace hospitalisation when clinically needed. It is available only through a restricted programme (REMS) and is self-administered under direct observation in a certified healthcare setting.
Racemic ketamine (the anaesthetic, Ketalar) is FDA-approved only as an injectable anaesthetic. The FDA states that "Ketamine is not FDA approved for the treatment of any psychiatric disorder." Psychiatric use (for example intravenous infusion clinics, or compounded oral or sublingual products, including at-home use via telehealth) is off-label and is not covered by the esketamine REMS.

How change is thought to happen: the labelling describes a rapid-acting antidepressant effect from a drug acting on the glutamate system (NMDA receptor antagonist), with transient dissociation, sedation and blood pressure rises as expected effects that require supervision [source: EMA SmPC section 4.4; Drugs.com Spravato PI]. For the psychotherapist, the working assumption is that the medicine may open a window of symptom relief, and that durable change still depends on ongoing psychiatric care, psychotherapy, safety planning and life changes [synthesis].

2. Framework

Who delivers it and regulatory status (as sources state)

United States. Esketamine: dispensed and administered only in REMS-certified healthcare settings; pharmacies must be certified and may dispense only to certified settings; outpatient offices must be enrolled. The patient self-administers the nasal spray under direct observation of a healthcare provider [source: Drugs.com Spravato PI]. The REMS remains in force; a June 2026 FDA letter approved only website workflow changes, with no change to monitoring requirements [source: FDA letter NDA 211243/S-029, 24 June 2026]. Racemic ketamine: Schedule III controlled substance; all psychiatric uses are off-label; according to a January 2026 legal analysis, "No comprehensive regulatory scheme has emerged" for psychiatric ketamine across delivery models, oversight falls to state medical boards, DEA registration rules and enforcement, and telehealth prescribing rules for controlled substances were described as unsettled [source: PharmExec, Creizman 2026] [uncertain: telehealth rules change; check the current DEA position].
European Union. Esketamine is authorised for treatment-resistant major depressive disorder (with an SSRI or SNRI) and as acute short-term treatment of depressive symptoms in a psychiatric emergency (with oral antidepressant therapy). The decision to prescribe should be made by a psychiatrist; the patient self-administers under the direct supervision of a healthcare professional; Member States must run a controlled access programme to minimise abuse; healthcare professionals receive a guide and a checklist for deciding when a patient may leave, and patients receive a patient guide [source: EMA SmPC sections 4.1, 4.2, Annex II].
United Kingdom. Esketamine is licensed for treatment-resistant depression. NICE does not recommend it, within its marketing authorisation, for treatment-resistant depression in adults (TA854); people who started it on the NHS before the guidance can continue until they and their clinician decide to stop. In June 2024 NICE decided not to review TA854 [source: NICE TA854 recommendations; NICE review decision 2024]. A news report of the Royal College of Psychiatrists' 2025 position statement (PS02/25) says the College backs ketamine-based medication for depression "in specialist settings with appropriate oversight and long-term monitoring arrangements", that esketamine is available on the NHS in Scotland but not England, and that its president warned against "back-street clinics" [source: LBC report; RCPsych PS02/25 body text uncertain].
Other jurisdictions (Canada, Australia and others) were not checked [uncertain].

Phases as the psychotherapist meets them

The psychotherapist does not set the medical course. Course length, session frequency and continuation are set by the prescriber according to labelling and are deliberately not given here. The phases below describe the psychotherapist's work around each stage [synthesis, built on labelling requirements cited].

Before referral (exploration). Goal: recognise when a medical review of depression treatment is warranted, give balanced information, and route to the prescriber. Format: within ordinary therapy sessions. Move on when the client has a psychiatric assessment arranged.
Prescriber assessment and decision. The prescriber assesses eligibility: psychiatric diagnosis and history including psychosis and substance use, abuse risk, cardiovascular and cerebrovascular history, blood pressure, pregnancy potential, other medicines [source: EMA SmPC 4.3, 4.4; Medication Guide; APA consensus as reported]. Psychotherapist goal: support informed consent and shared decision-making; prepare practical plans. Move on when the prescriber and client have decided.
Treatment course (in-clinic sessions). Each treatment session takes place in the certified clinic: blood pressure assessed before and after dosing, observation for at least 2 hours in the US label (until clinically stable in the EU), discharge only once clinically stable, no driving or machinery until the next day after restful sleep [source: Drugs.com Spravato PI; EMA SmPC 4.2, 4.7]. Psychotherapist goal: continue regular psychotherapy, monitor mood, suicidality and side effects, help with practical and emotional preparation and brief processing. Weekly or fortnightly psychotherapy is a common pattern [synthesis].
Continuation or ending. The prescriber reviews response and decides on continuation. Psychotherapist goal: consolidate gains, relapse-prevention planning, support through any interruption (for example a clinic closing) or ending [source for interruption guidance: CDC factsheet on esketamine and ketamine disruption events].
After treatment. Ongoing psychotherapy and relapse prevention; watch for return of symptoms and for any non-medical ketamine use [synthesis].

Criteria for moving between phases are medical decisions made by the prescriber. The psychotherapist's role is to make sure the prescriber has the information it needs (with consent) about mood, risk, side effects and functioning.

3. Guiding principles

[source: labelling and regulator documents cited per line; practical meanings are synthesis]

The prescriber owns the medicine. Never tell or imply that a client should start, stop, change or obtain ketamine or esketamine; every medicine question goes to the prescriber.
Not a substitute for crisis care. The US label states esketamine does not replace hospitalisation when clinically needed and has not been shown to prevent suicide [source: Drugs.com PI]. Suicide risk is assessed and managed in its own right, whatever the treatment status.
Supervision is part of the treatment. Dissociation and perceptual changes are among the most frequent effects and are "considered part of the treatment experience requiring supervision" in the EU wording as summarised [source: EMA SmPC 4.4]. Practical meaning: present supervised administration and post-dose observation as safety features, not bureaucratic hurdles.
Approved and off-label are different things. Practical meaning: describe esketamine labelling accurately, and describe racemic ketamine clinics and compounded or at-home products as off-label with regulator warnings, without endorsing or disparaging a client's prescriber [source: FDA 2023].
Vigilance for misuse without stigma. Labelling requires abuse-risk assessment before and during treatment [source: Medication Guide; EMA SmPC 4.4]. Practical meaning: ask about substance use routinely and matter-of-factly; pass concerns to the prescriber.
Watch-and-report, not diagnose. Practical meaning: know the labelled warning signs and pass them on promptly with consent; urgent signs go to emergency services.
Psychotherapy continues. Practical meaning: the medicine is not a reason to pause evidence-based psychotherapy for depression [synthesis].
Consent-based collaboration. Practical meaning: obtain written consent to share information with the prescriber and clinic; agree who calls whom about what.
Stay in role. Practical meaning: unless you are trained and working within a structured ketamine-assisted psychotherapy programme (Domain VII), you are not a sitter, guide or monitor during dosing.
Accuracy over hope or fear. Practical meaning: avoid both the media hype and the alarm; quote labelling, and mark what is uncertain [source: LBC report of RCPsych cautions about claims that "jump ahead of the evidence"].

4. Intervention inventory

Part A describes how the treatment is delivered, as labelling and regulators publish it, at a descriptive level only. Part B gives the psychotherapist's own interventions. Example language throughout is illustrative wording for this guide, not taken from any manual.

Part A. How the treatment is delivered (descriptive)

A1. Esketamine nasal spray (Spravato) in a certified setting

Purpose: know what the client will experience and what the clinic must do, so you can prepare the client accurately and spot gaps.
Steps (as labelling describes, not instructions):
1. A prescriber (in the EU, a psychiatrist decides) assesses eligibility and abuse risk [source: EMA SmPC 4.2, 4.4].
2. Contraindications listed in the US label: aneurysmal vascular disease or arteriovenous malformation, history of intracerebral haemorrhage, hypersensitivity to esketamine or ketamine. The EU SmPC adds conditions where a rise in blood pressure or intracranial pressure is a serious risk, including a recent cardiovascular event such as myocardial infarction [source: Drugs.com PI; EMA SmPC 4.3].
3. At each treatment session, blood pressure is assessed before dosing and reassessed after; the client self-administers the nasal spray under direct observation; pre-dose restrictions on food and drink and on some nasal medicines apply, as the clinic will explain [source: Drugs.com PI; EMA SmPC 4.2; Medication Guide].
4. Post-dose observation: at least 2 hours in the US label, including respiratory status with pulse oximetry and assessment of sedation and dissociation; discharge only when clinically stable. The EU wording is monitoring until clinically stable and ready to leave, using a healthcare-professional checklist [source: Drugs.com PI; EMA SmPC 4.2, Annex II].
5. The client needs arranged transport and must "not drive or operate machinery until the next day after a restful sleep" [source: Drugs.com PI].
Boxed warning (US): sedation, dissociation and respiratory depression (hence the 2-hour monitoring); abuse and misuse (hence the REMS); suicidal thoughts and behaviours in young patients taking antidepressants; not approved for paediatric use [source: Drugs.com PI].
Other labelled warnings: increases in blood pressure; cognitive impairment; impaired ability to drive; ulcerative or interstitial cystitis; embryo-fetal toxicity (not to be used in pregnancy, no breastfeeding); careful assessment of anyone with a history of psychosis; caution in mania or bipolar disorder (EU); falls risk in older people (EU) [source: Drugs.com PI; Medication Guide; EMA SmPC 4.4].
Common adverse reactions (US): dissociation, dizziness, nausea, sedation, vertigo, reduced sensation (hypoesthesia), anxiety, lethargy, raised blood pressure, vomiting, feeling drunk, headache; euphoric mood in the suicidal-ideation population [source: Drugs.com PI].
Watch for (psychotherapist): the client knows they cannot drive that day; has a plan for transport and the rest of the day; understands dissociation is expected but monitored; reports bladder, breathing, chest pain, severe headache, vision changes or cognitive problems [source: Medication Guide].

A2. Racemic ketamine in off-label clinics (for example intravenous infusion)

Purpose: understand a common route by which clients encounter ketamine, and its regulatory position.
Status as sources describe: ketamine is FDA-approved only as an injectable anaesthetic; psychiatric use is off-label; ketamine is Schedule III; no REMS applies; no comprehensive federal scheme governs psychiatric ketamine; state medical boards discipline over documentation, consent and advertising, and federal prosecutors and the DEA have acted against some clinics and tele-prescribers (allegations as reported) [source: FDA 2023; PharmExec 2026; CDC factsheet]. In the UK, racemic ketamine for depression is unlicensed use [uncertain: not confirmed in a UK regulator source].
What the 2017 APA task force consensus statement recommended (as reported; the statement says it is not a standard or guideline): a full pre-treatment psychiatric assessment with attention to substance use and psychosis, physical examination and tests matched to expected sedation, baseline urine toxicology; clinicians able to manage sedation and cardiac emergencies; a site-specific standard operating procedure with monitoring of breathing, heart and mental status and defined stopping criteria; discharge to an adult caregiver; written informed consent that covers limited long-term data; concern about cognitive impairment, cystitis and abuse with frequent long-term use [source: MDedge report of Sanacora et al. 2017].
Watch for (psychotherapist): whether the clinic did a psychiatric assessment, who is responsible for ongoing psychiatric care, whether there is a crisis pathway, and how the clinic communicates with other clinicians [synthesis].

A3. Compounded and at-home ketamine (oral, sublingual, telehealth)

Purpose: be able to describe regulator warnings to clients who use or consider these products.
What the FDA warns (10 October 2023): compounded drugs are not FDA-reviewed for safety, effectiveness or quality; compounded ketamine, including oral and sublingual forms sold via telemedicine for at-home use, carries risks of abuse and misuse, psychiatric events, raised blood pressure, respiratory depression and lower urinary tract and bladder symptoms; at home "onsite monitoring by a health care provider is not available"; the FDA received a report in April 2023 of respiratory depression in a patient using compounded oral ketamine at home for PTSD; compounded ketamine is not under a REMS [source: FDA 2023].
Further risks named by CDC: illegally sourced ketamine may contain unknown additives including fentanyl; combining ketamine with opioids, benzodiazepines or alcohol may cause sedation, slowed breathing, coma, seizures and death; abrupt discontinuation after heavy use can bring cravings, irritability, anxiety and depression [source: CDC factsheet].
Watch for: use alone without another adult present, use with alcohol or sedatives, escalating use, bladder symptoms, use outside prescription [synthesis informed by FDA and CDC].

Part B. The psychotherapist's interventions

B1. Recognising when to suggest a medical review

Purpose: route clients whose depression has not responded to treatment to a prescriber, without steering them to a specific drug.
When: persistent moderate-to-severe depression despite treatment; repeated relapses; the client raises ketamine after media coverage; you are uncertain whether the current medicine plan is working [synthesis].
Steps: 1) Summarise what has and has not helped, using measures you routinely use. 2) Name that medicine options are the prescriber's domain. 3) Offer to write (with consent) a short summary for the prescriber. 4) If acute suicidality is present, follow the crisis pathway first; esketamine is not a substitute for hospitalisation [source: Drugs.com PI] [synthesis for steps].
Example language (illustrative): "You've worked hard at this and the low mood hasn't shifted the way we hoped. I think it's worth a review with your psychiatrist about all the options, including the newer ones you've read about. Shall I send them a summary of what we've tried here?"
Watch for: the client hearing "ketamine is your answer"; correct this. Working: the client books a review and brings questions.

B2. Psychoeducation from the labelling

Purpose: give accurate, balanced information.
Steps: 1) Explain the difference between esketamine (approved, REMS, in-clinic) and racemic ketamine (anaesthetic approval, off-label psychiatric use) [source: FDA 2023]. 2) Describe what a clinic visit involves: blood pressure checks, self-administered spray under observation, a monitoring period, no driving until next day after sleep [source: Drugs.com PI]. 3) Describe expected effects (dissociation, dizziness, nausea, sedation) and that they are monitored [source: Drugs.com PI]. 4) Say clearly that it has not been shown to prevent suicide [source: Drugs.com PI]. 5) Point to the Medication Guide or EU patient guide as the authoritative patient text. 6) Defer all questions about doses and suitability to the prescriber.
Example language (illustrative): "Feeling detached or as if things look strange during the session is one of the most common effects. That's why the clinic watches you until it settles and you're cleared to leave."
Watch for: misinformation from social media or marketing; overstated claims ("cure") or catastrophic fears. Working: the client can describe the visit and the warnings in their own words.

B3. Supporting informed consent and shared decision-making

Purpose: help the client arrive at the prescriber appointment able to weigh options.
Steps: 1) Elicit values and goals (speed of relief, side-effect concerns, practical burden of clinic visits and transport, costs) [synthesis]. 2) Help the client list questions for the prescriber, for example: Am I eligible? What are the risks for me given my blood pressure, pregnancy plans, past substance use or psychosis history? Who handles a crisis? How will we decide whether it is working? What happens if the clinic closes? [source for risk areas: Medication Guide; EMA SmPC; CDC factsheet]. 3) Explore the decision without stating a preference. 4) Record that information was given and that the medical decision rests with the client and prescriber.
Example language (illustrative): "My job isn't to tell you whether to have it. It's to help you get clear on what matters to you and what to ask, so the decision you make with your psychiatrist really is yours."
Watch for: pressure from family or from a clinic's marketing; desperation narrowing choice. Working: the client attends with written questions and reports understanding the answers.

B4. Practical preparation for treatment days

Purpose: reduce avoidable risks and missed sessions.
Steps: 1) Plan transport to and from every session, since the client must not drive until the next day after restful sleep [source: Drugs.com PI]. 2) Plan the rest of the day: no work needing alertness, no machinery, ideally someone at home [synthesis]. 3) Prompt the client to tell the clinic about all medicines and substances, including alcohol and sedatives [source: Medication Guide]. 4) Encourage the client to follow the clinic's pre-session instructions exactly. 5) Plan how to reach the clinic and you between sessions.
Example language (illustrative): "Let's work out the treatment-day plan now: who's driving you home, and what does the rest of your day look like?"
Watch for: plans to drive or go back to work; no support at home. Working: plan written and used.

B5. Preparing for dissociation and perceptual changes

Purpose: reduce fear and help the client describe experiences to the clinic team.
Steps: 1) Describe dissociation in plain terms (feeling disconnected from self, thoughts, feelings, space and time) [source: Medication Guide]. 2) Teach one or two simple grounding skills the client already finds useful, for use in the observation period if the clinic agrees [synthesis]. 3) Encourage the client to tell staff about distress, and to note what happened afterwards. 4) For clients with trauma histories or dissociative disorders, discuss with the prescriber before treatment [synthesis] [uncertain: no labelling guidance on dissociative disorders was found].
Example language (illustrative): "If it feels strange, that's expected and staff are right there. You can tell them, and you can use the feet-on-the-floor grounding we practised."
Watch for: panic, re-experiencing of trauma, persistent dissociation after discharge (report to the prescriber). Working: the client describes sessions as manageable.

B6. Brief processing after sessions (not structured KAP)

Purpose: help the client make sense of the experience and link any relief to ongoing therapy goals. Structured ketamine-assisted psychotherapy, in which the drug experience is used as therapy material in a planned model, is in Domain VII.
Steps: 1) Next psychotherapy session: ask open questions about the experience and the days after. 2) Separate meaning-making from medical observations; pass side effects to the prescriber. 3) Use any window of improved mood to re-engage behavioural activation, problem solving or other active work from your usual approach [synthesis].
Example language (illustrative): "What was it like, and what have you noticed in the days since? If your energy is a bit better, which of the things we put on hold could you try this week?"
Watch for: the client attributing profound or spiritual meaning and wanting more frequent or unsupervised use; refer back to the prescriber and to Domain VII for structured approaches. Working: gains translate into activity and functioning.

B7. Monitoring and passing on side effects and warning signs

Purpose: act as an extra pair of eyes between clinic visits.
Steps: 1) At each session during the course, do a brief check covering the Medication Guide warning signs: suicidal thoughts or attempts; new or worse depression, anxiety or panic; agitation, restlessness, insomnia; aggression or irritability; mania; acting on dangerous impulses; feeling unable to stay awake or about to faint; breathing difficulty; chest pain, shortness of breath, sudden severe headache, vision changes, seizures; trouble thinking or remembering; urinary trouble or pain [source: Medication Guide]. 2) Ask about persistent dissociation or perceptual changes after sessions. 3) Agree in advance (with consent) how and when you contact the prescriber. 4) Urgent signs (breathing problems, chest pain, seizures, sudden severe headache, imminent suicide risk): emergency services first, then the prescriber. 5) Advise the client that side effects can also be reported to the regulator (FDA MedWatch in the US) [source: Medication Guide; FDA 2023]. 6) Document what was observed and to whom it was passed.
Example language (illustrative): "Before we start, a quick check-in on how the treatment's been: any trouble with your bladder, thinking, sleep, or any new urges or dark thoughts?"
Watch for: under-reporting because the client fears losing the treatment. Working: concerns reach the prescriber promptly and the client knows how to report.

B8. Suicide risk assessment and safety planning

Purpose: keep risk management active throughout; the medicine is not a suicide-prevention treatment.
Steps: 1) Assess risk with your service's standard approach at baseline and at every contact during the course [synthesis]. 2) Build or update a written safety plan (warning signs, coping steps, people and places, professional and crisis contacts, making the environment safer through storage and removal of means). 3) Note the labelled caution that antidepressants can increase suicidal thoughts and actions in people aged 24 and younger, especially early in treatment or when doses change [source: Medication Guide]. 4) Include in the plan what to do if the clinic closes or access is lost; CDC notes symptoms, including suicidal thoughts, may return, and directs people with suicidal thoughts after losing access to their clinician or an emergency room [source: CDC factsheet]. 5) Do not let a pending esketamine appointment delay an indicated crisis admission [source: Drugs.com PI].
Example language (illustrative): "Even if the treatment helps quickly, I want us to keep your safety plan up to date. Let's add what you'd do if your appointments were cancelled or you felt worse after a session."
Watch for: sudden improvement followed by a crash; hopelessness if early sessions do not help. Working: the plan is current and used.

B9. Substance use and misuse vigilance

Purpose: support the labelled requirement to monitor for abuse, misuse and dependence [source: Medication Guide; EMA SmPC 4.4].
Steps: 1) Ask routinely about alcohol, sedatives, opioids, stimulants and non-prescribed ketamine. 2) Explore any wish for more frequent or at-home use. 3) Share concerns with the prescriber (with consent, or under your service's safeguarding duties if risk is serious). 4) If misuse is present, offer or refer to substance-use treatment [synthesis].
Example language (illustrative): "Some people find they want that feeling more often or try getting ketamine elsewhere. If that happens for you, I'd rather we talk about it openly."
Watch for: seeking extra supplies, online purchase, use with alcohol, bladder symptoms. Working: honest disclosure.

B10. Conversations about adherence and ambivalence (never advising a change)

Purpose: help the client resolve ambivalence and bring it to the prescriber.
Steps: 1) Explore both sides with open questions and reflections (for example burden of visits, cost, side effects, fear of dependence, wish to keep going). 2) Summarise and ask what the client wants to raise with the prescriber. 3) State plainly that decisions to start, stop or change are made with the prescriber. 4) Help prepare for that conversation [synthesis].
Example language (illustrative): "It sounds like part of you wants to keep going because the mornings are easier, and part of you hates the travel and the spaced-out feeling. That's a really important thing to talk through with your psychiatrist. What would you want to say to them?"
Watch for: missed sessions, stopping without telling the prescriber, a pull toward unregulated sources. Working: ambivalence is discussed with the prescriber.

B11. Collaborative care communication

Purpose: one coordinated plan across psychotherapist, prescriber and clinic.
Steps: 1) Obtain written consent specifying what is shared and with whom. 2) Agree roles: who leads on medical decisions, risk and crisis response, and who contacts whom. 3) Send concise updates (mood measures, risk, observed side effects, functioning). 4) Ask the clinic how the client can be reached between sessions and what its out-of-hours pathway is [synthesis].
Example language (illustrative, to a prescriber): "With [client]'s consent: since starting treatment, PHQ-9 scores have moved from X to Y; she reports new urinary urgency and two nights of poor sleep. No change in suicide risk. I've advised her to raise the urinary symptoms with you."
Watch for: no named responsible clinician (more common in off-label settings) [synthesis]. Working: timely two-way contact.

B12. Integrating psychotherapy before, during and after treatment

Purpose: keep evidence-based psychotherapy as the backbone.
Steps: 1) Before: set therapy goals that do not depend on the medicine. 2) During: continue your usual approach; use any lift in mood to strengthen active components; avoid scheduling demanding sessions on treatment days, when the client may be sedated or unable to travel safely [synthesis]. 3) After: relapse-prevention plan, early-warning signs, maintaining routines [synthesis].
Example language (illustrative): "Whatever the treatment does, the skills we build here are yours to keep."
Watch for: the client or service treating psychotherapy as optional. Working: sustained functional gains.

B13. Treatment interruption and ending

Purpose: support clients through planned endings and unplanned disruptions.
Steps: 1) Discuss in advance what happens if treatment ends or is interrupted. 2) If a certified clinic closes or the prescriber leaves, CDC guidance is that patients needing ongoing treatment should continue with another provider in the same setting or another REMS-certified setting; patients do not re-enrol, but enrolment is verified before any dose; the Spravato REMS call centre helps find a certified setting [source: CDC factsheet]. 3) Help the client contact the prescriber or REMS call centre; never suggest an alternative source. 4) Increase contact and update the safety plan during gaps [synthesis].
Example language (illustrative): "Let's call the clinic together now to find out where your care moves to, and step up our sessions until it's sorted."
Watch for: return of symptoms or suicidal thoughts; turning to street or online ketamine [source: CDC factsheet]. Working: continuity maintained.

B14. Talking with clients who use or consider off-label, compounded or at-home ketamine

Purpose: give accurate regulator information and keep the client connected to care.
Steps: 1) Ask non-judgementally what they use, from where, prescribed by whom, and whether anyone is with them during use. 2) Share the FDA's warnings: not approved for psychiatric disorders, compounded products not FDA-reviewed, no onsite monitoring at home, risks of respiratory depression, raised blood pressure, psychiatric events, bladder symptoms and abuse [source: FDA 2023]. 3) Share CDC cautions on combining with alcohol, opioids or benzodiazepines and on contaminated illegal supply [source: CDC factsheet]. 4) Encourage the client to discuss this with their prescriber or GP; do not tell them to stop or continue. 5) Safety-plan for overdose or crisis [synthesis].
Example language (illustrative): "I'm not going to tell you what to do with it, but I'd like you to know what the regulator has said about at-home ketamine, and I'd really encourage you to go over it with your doctor."
Watch for: solitary use, combining with sedatives, escalating use. Working: the client discusses use with a prescriber.

B15. Groups needing extra care (pass to the prescriber)

Purpose: flag labelled risk groups.
Points: pregnancy or plans for pregnancy, and breastfeeding (embryo-fetal toxicity; not for use in pregnancy; pregnancy registry noted) [source: Medication Guide]; people aged 24 and under (suicidality warning; not approved for children) [source: Drugs.com PI; Medication Guide]; history of psychosis, mania or bipolar disorder [source: Medication Guide; EMA SmPC 4.4]; substance use history [source: Medication Guide]; cardiovascular or cerebrovascular disease and raised blood pressure [source: EMA SmPC 4.3]; older people (falls) [source: EMA SmPC 4.4]; jobs involving driving or machinery [source: EMA SmPC 4.7].
Example language (illustrative): "You mentioned you're hoping to get pregnant next year; that's something the label says the prescriber needs to know about. Can you raise it with them?"
Watch for: clients not disclosing. Working: the prescriber has the information.

5. Handling problems

The sources (labelling, regulators) describe the medical risks but not the psychotherapist's responses. All responses below are [synthesis] unless a source is named.

Client wants ketamine "as a last resort" and pressures you to endorse it. Acknowledge the desperation; restate that the decision belongs with a prescriber; offer B3 and a referral summary. Keep working on hope and safety in the meantime.
Stuck: no response after starting treatment. Normalise variable response; pass the observation to the prescriber; keep psychotherapy goals independent of the medicine; review the safety plan, since hopelessness may rise if a hoped-for treatment fails.
Sudden improvement then crash. Treat as a risk point: reassess suicide risk, contact the prescriber with consent, increase session frequency.
Overwhelm or distressing dissociation in sessions. The clinic manages acute effects in the observation period [source: Drugs.com PI; EMA SmPC]. Afterwards, process the experience, rehearse grounding, and encourage the client to report to the prescriber; persistent dissociation, perceptual disturbance or psychotic symptoms after discharge go to the prescriber urgently.
Trauma memories surfacing. Contain and stabilise in the next session; do not turn it into unplanned trauma processing; discuss pacing with the client and prescriber. Planned trauma-focused work linked to ketamine sessions belongs to structured KAP (Domain VII).
Non-adherence (missed clinic visits). Explore practical barriers (transport on treatment days, cost, work); problem-solve; encourage the client to tell the clinic. Never suggest skipping, shifting or adding sessions.
Resistance to continuing psychotherapy ("the spray fixes it"). Validate relief; link continued therapy to relapse prevention; agree a review point.
Wanting more, or seeking ketamine elsewhere. Use B9 and B14; share FDA and CDC warnings [source: FDA 2023; CDC factsheet]; inform the prescriber within consent and safeguarding rules.
Driving after treatment. Restate the labelling: no driving until the next day after restful sleep [source: Drugs.com PI]; if the client plans to drive regardless, raise with the clinic; consider risk to others under your professional duties.
Bladder or urinary symptoms. Prompt reporting to the prescriber; labelling and regulators list cystitis and lower urinary tract symptoms [source: Drugs.com PI; FDA 2023].
Rupture: client feels you are "against" their ketamine clinic. Repair: clarify that your role is safety and information, not judgement of their choice; separate the clinic's off-label status (a fact) from the client's worth or judgement.
Rupture: client feels you are "pushing" a drug. Repair: restate neutrality and that medicine decisions are theirs and the prescriber's.
Clinic offers no psychiatric follow-up or crisis cover. Ask the client for permission to contact the clinic; make sure a GP or psychiatrist holds ongoing care; document. The APA consensus statement stressed full psychiatric assessment and planning for follow-up [source: MDedge report of Sanacora et al. 2017].
Clinic closure or loss of access. Follow B13 and CDC guidance [source: CDC factsheet].
Client is pregnant or planning pregnancy. Prompt immediate contact with the prescriber [source: Medication Guide].
Client is young (24 or under). Heighten monitoring for suicidal thoughts and behaviour change, involve family where appropriate [source: Medication Guide].
Cost and access inequity (for example NICE not recommending esketamine in England). Explain status factually [source: NICE TA854]; help the client discuss NHS options with their clinician; warn about unregulated alternatives.
Your own competence limits. If a client asks you to sit with them during at-home use, decline; this is outside your role and the FDA warns at-home use lacks monitoring [source: FDA 2023]. Refer interested clients to Domain VII for how structured KAP is delivered by trained teams.

Sources

Sources: