You are likely a Spravato candidate if you are 18 or older, have major depressive disorder, and at least two antidepressants at adequate doses for six weeks or more have not worked. Major depression with acute suicidal thoughts also qualifies. Aneurysms, brain bleeds, uncontrolled blood pressure and pregnancy rule it out or require caution.
This page walks through each criterion the way we apply it at Stedfast Psychiatry, what counts as a failed antidepressant trial, which conditions rule Spravato out, and which situations call for extra caution. If you recognize yourself in the first section, an evaluation at any of our three Palm Beach County Spravato offices is the next step.
Who it is for
There are two FDA-approved paths. The first is treatment-resistant depression: a current episode of major depressive disorder that has not adequately responded to at least two different oral antidepressants taken at a therapeutic dose for an adequate duration, generally six to eight weeks each. Those two medications can be from the same class or different classes, and augmentation strategies such as adding an antipsychotic or lithium usually count as well. Most insurance plans require documentation of these trials, including names, doses and dates.
The second path is major depressive disorder with acute suicidal ideation or behavior. Here the goal is rapid symptom reduction in a person who is safe enough to be treated as an outpatient but is in a dangerous stretch, often after an emergency room visit or hospitalization. Prior medication failures are not required for this indication, but you must be on an oral antidepressant alongside Spravato, and Spravato does not replace a safety plan or hospitalization when that is needed.
In both cases you must be 18 or older. Spravato is not approved for children or adolescents, and a pediatric trial did not show benefit.
How it works
At your evaluation, one of our psychiatrists or psychiatric nurse practitioners confirms the diagnosis with a structured interview and the PHQ-9 and MADRS rating scales. We build a medication history: what you took, at what dose, for how long, and what happened. We check your blood pressure, ask about heart disease, stroke, aneurysm and brain injury, and screen for substance use and for bipolar disorder, since esketamine was not studied in bipolar depression and could in theory trigger mania. We review your current medications for interactions, especially benzodiazepines, stimulants and MAOIs. If everything fits, we submit the prior authorization and enroll you in the REMS program.
About 30 percent of adults treated for major depression do not reach remission after two adequate antidepressant trials, which is the threshold for treatment-resistant depression.
Source: STAR*D trial, National Institute of Mental Health; Rush et al., American Journal of Psychiatry, 2006
The FDA-approved Spravato indications are treatment-resistant depression in adults and major depressive disorder with acute suicidal ideation or behavior in adults; the label does not include patients under 18.
Source: Spravato prescribing information, FDA
In the pivotal TRANSFORM-2 trial, enrolled patients had failed a median of two to three antidepressants in the current episode, and about half had been depressed for more than two years.
Source: Popova et al., American Journal of Psychiatry, 2019
Esketamine raised systolic blood pressure by an average of about 7 to 9 mm Hg at 40 minutes after dosing in short-term trials, with larger rises in a minority of patients.
Source: Spravato prescribing information, FDA
What to expect
The evaluation takes about an hour and can be done in person or by telehealth, though your first dose must be in the office. Bring a list of prior medications if you can, or sign a records release so that we can obtain it. If you qualify, most insurance authorizations come back within one to two weeks, and we schedule your induction sessions in a block so that you have the twice-weekly cadence set from the start. If you do not qualify, we tell you why and what we recommend instead, which may be a different medication strategy, Deep TMS at our Palm Beach Gardens office, or a referral for ECT.
Benefits
- Clear, label-based criteria so you know before the evaluation whether you are likely to qualify
- Documentation of prior trials handled by our staff for insurance prior authorization
- Screening protects you: blood pressure, vascular history and substance use checks are built into the process
- If you do not qualify, you leave with a specific alternative plan rather than a dead end
Risks and side effects
Absolute contraindications, where we will not prescribe Spravato: aneurysmal vascular disease anywhere in the body (including aortic, intracranial and peripheral aneurysms), arteriovenous malformation, a history of intracerebral hemorrhage, and hypersensitivity to esketamine or ketamine. Relative cautions that require discussion and sometimes additional workup: uncontrolled hypertension or a recent cardiovascular event, since esketamine raises blood pressure; a history of substance use disorder, since esketamine carries misuse potential and is a controlled substance; pregnancy or breastfeeding, since animal data show possible fetal harm and the drug has not been studied in pregnant women; a history of psychosis, which can worsen; and significant liver disease, which slows clearance.
Cost and insurance
Insurance plans mirror the FDA criteria. For treatment-resistant depression, nearly every plan requires documented failure of two antidepressants, and some require a trial of augmentation or psychotherapy as well. For the suicidal ideation indication, plans generally approve quickly with a clinical note. Medicare Part B does not require prior authorization for the drug itself but does require that the medical record support medical necessity. Our Spravato cost, insurance and Medicare page covers this in detail.
Candidate checklist
You are likely a candidate if all of the following are true:
- You are 18 or older.
- You have a diagnosis of major depressive disorder, not bipolar disorder or a psychotic disorder.
- In your current episode, at least two different antidepressants at adequate doses for at least six weeks each have not worked, or you have acute suicidal thoughts with major depression.
- You have no aneurysm, arteriovenous malformation or history of bleeding in the brain.
- Your blood pressure is controlled, or can be controlled before starting.
- You are not pregnant or breastfeeding.
- You can commit to twice-weekly office visits of about two and a half hours for the first month, with a ride home each time.
Situations that need a closer look
| Situation | What it means for Spravato |
|---|---|
| Uncontrolled high blood pressure | Treat first; we recheck before each dose and withhold if too high |
| Recent heart attack, stroke or heart failure | Cardiology clearance before starting |
| Past alcohol or drug use disorder | Individual assessment; often workable because the drug never leaves the office |
| Current benzodiazepine use | Can blunt the response and add sedation; we may adjust timing or dose |
| History of psychosis | Generally avoid; dissociation can worsen psychotic symptoms |
| Pregnancy, breastfeeding or planning pregnancy | Not recommended; discuss alternatives |
| Significant liver disease | Slower clearance; longer monitoring and careful dosing |
| Age 65 and older | Eligible; the trial in older adults showed a smaller effect, and we start at 28 mg and watch blood pressure closely |
Spravato, TMS or something else?
Many candidates for Spravato are also candidates for Deep TMS, which we offer at Palm Beach Gardens. TMS is FDA-cleared for major depressive disorder and has no drug side effects, but requires daily visits for six to nine weeks. Spravato involves a drug with dissociative effects and a ride home, but fewer total visits and a faster expected onset. People with active suicidal ideation, a strong need for rapid relief, or a schedule that cannot absorb daily appointments often lean toward Spravato. People who want to avoid medication effects entirely, or who have a contraindication to esketamine, often lean toward TMS. Some patients do both in sequence. Our Spravato vs TMS page compares them in detail, and your provider will recommend one based on your history rather than on what we happen to offer at the office you visit.
Practical readiness
Qualifying medically is one half. The other half is logistics. The first four weeks require eight visits, each roughly two and a half hours, with someone to drive you home. If you work, you may need to schedule sessions in the late morning so that you can rest afterward, or use intermittent FMLA leave, which we can document. If transportation is a problem, ride-share services are acceptable. We raise all of this at the evaluation because a candidate who cannot complete induction will not get the benefit.
Spravato at Stedfast Psychiatry
We offer Spravato at three Palm Beach County offices, each with a dedicated monitoring room and staff trained under the Spravato REMS program:
- Boynton Beach: 10301 Hagen Ranch Rd, Suite D720, Boynton Beach, FL 33437
- Palm Beach Gardens: 11641 Kew Gardens Ave, Suite 209, Palm Beach Gardens, FL 33410
- Royal Palm Beach: 420 South State Road 7, Suite 112, Royal Palm Beach, FL 33414
Call the office nearest you or request an appointment online. The first step is an evaluation, in person or by telehealth, to confirm you are a candidate and to start insurance authorization.
Frequently asked questions
What counts as a failed antidepressant?
A medication taken at a dose within the therapeutic range for at least six weeks (eight for some plans) without a satisfactory improvement, or stopped early because of side effects after a reasonable attempt. Two SSRIs count as two trials. An augmentation step, such as adding aripiprazole or lithium to an antidepressant, generally counts as an additional trial. Stopping a medication after a week because you did not like it usually does not count. We document each trial with name, dose and dates.
Do I have to be on an antidepressant to take Spravato?
Not anymore for treatment-resistant depression. Since January 2025, Spravato is FDA-approved as a standalone treatment, so patients who cannot tolerate oral antidepressants can take it alone. Many patients still continue an antidepressant because the combination was what the original trials studied and the maintenance data are longer. For the suicidal ideation indication, an oral antidepressant is still required alongside Spravato.
Can I get Spravato if I have bipolar disorder?
Spravato is not FDA-approved for bipolar depression, and people with bipolar disorder were excluded from its trials because NMDA antagonists can in theory trigger mania. We do not prescribe it for bipolar depression. If you have bipolar disorder and depression that has not responded to treatment, we have other evidence-based options, including lithium, lamotrigine, quetiapine, lurasidone and Deep TMS.
Is Spravato approved for PTSD or anxiety?
No. Spravato is approved only for treatment-resistant depression and major depression with acute suicidal ideation. Some clinics offer ketamine products off-label for PTSD, OCD and anxiety, but the evidence is thin and insurance will not cover it. If you have PTSD and also meet criteria for treatment-resistant major depression, you may qualify on the depression diagnosis, and we would treat the PTSD with trauma-focused therapy and appropriate medication at the same time.
Can teenagers get Spravato?
No. The FDA approval is for adults 18 and older. A trial of esketamine in adolescents with depression and suicidal ideation did not meet its primary endpoint, and the REMS program does not permit use under 18. For adolescents with severe or treatment-resistant depression we use evidence-based medication strategies, therapy and, when appropriate, referral for TMS or inpatient care.
What if I have high blood pressure?
Controlled hypertension is not a barrier. We will check your blood pressure before every dose and will not administer Spravato if it is above a safe threshold that day. Uncontrolled hypertension needs to be managed first, often with a quick visit to your primary care provider. A history of heart attack, stroke or a recent cardiovascular event requires clearance before starting. Aneurysms and brain bleeds rule Spravato out entirely.
Can I take Spravato if I have a history of substance use?
It depends. A past history of alcohol or substance use disorder is a caution, not an absolute contraindication, and many people in recovery have been treated safely because the drug is never dispensed to take home. Active substance use, especially alcohol, benzodiazepines or stimulants, is a problem both for safety during sessions and for the risk of misuse. We assess this honestly at the evaluation and may ask for a period of sobriety or coordinate with your addiction treatment provider.
What if I am pregnant or planning to be?
Spravato is not recommended during pregnancy. Animal studies show potential harm to the developing brain, and there are no adequate human data. We ask about pregnancy and contraception at the evaluation, and we recommend effective contraception during treatment. If you are breastfeeding, esketamine passes into milk and we would advise against it. If pregnancy is a possibility soon, we will discuss alternatives such as psychotherapy, pregnancy-compatible medications or TMS.
Where this treatment is offered
- Boynton Beach, FL
10301 Hagen Ranch Rd, Suite D720 and Suite B710 - Palm Beach Gardens, FL
11641 Kew Gardens Ave, Suite 209 - Royal Palm Beach, FL
420 South State Road 7, Suite 112
Conditions this treats
If you are in crisis, call or text 988 or go to the nearest emergency room. Educational content; individual results vary. Reviewed by Dr. David Husted, board-certified psychiatrist.