Spravato Shortage: What Providers and Prescribers Need to Know in 2026

Spravato (esketamine) is not on the FDA's official drug shortage list in 2026 — but as a prescriber treating patients with treatment-resistant depression (TRD), you are likely well aware that "not in shortage" does not mean "easily accessible." Structural access barriers continue to prevent a significant portion of appropriate candidates from initiating or maintaining Spravato treatment. This guide is designed to help you navigate these barriers on behalf of your patients.

Current Spravato Availability Status (2026)

Janssen Pharmaceuticals continues to manufacture and distribute SPRAVATO (esketamine) CIII nasal spray without reported supply shortages. The drug is available in 56 mg and 84 mg dose kits through specialty pharmacy distributors to REMS-certified healthcare facilities.

The key access challenges your patients face are not supply-side problems, but rather:

REMS-program requirements limiting administration sites

Insurance prior authorization processes and coverage denials

Geographic gaps in certified treatment center availability

High out-of-pocket costs for uninsured or underinsured patients

Logistical barriers (transportation requirements, 2-hour post-dose monitoring, session frequency)

2025 Regulatory Update: Spravato as TRD Monotherapy

On January 21, 2025, the FDA approved a supplemental NDA making Spravato the first and only FDA-approved monotherapy for adults with TRD (defined as inadequate response to at least 2 oral antidepressants of adequate dose and duration in the current episode). This supplemental approval was supported by a Phase 4 randomized, double-blind, placebo-controlled study (NCT04599855) in 378 adults with TRD.

Key clinical data from the pivotal trial: At Day 28, esketamine 56 mg showed a -5.1 MADRS total score improvement over placebo, and esketamine 84 mg showed a -6.8 MADRS improvement (both p<0.001). Improvements were observed approximately 24 hours after the first dose and sustained through the 4-week treatment period.

This labeling flexibility allows you to prescribe Spravato for TRD patients who cannot tolerate or refuse oral antidepressants, expanding its clinical utility. However, the REMS program requirements, administration protocols, and monitoring requirements remain unchanged.

REMS Program Requirements: What Prescribers Must Know

The SPRAVATO REMS program mandates that all parties — prescribers, healthcare settings, pharmacies, and patients — be certified or enrolled before treatment begins. Key requirements include:

Healthcare setting certification: All outpatient and inpatient settings must be REMS-certified before dispensing or administering Spravato.

Each dose must be self-administered by the patient under direct observation of a healthcare provider in the certified setting.

Post-dose monitoring for at least 2 hours is required at every session, followed by clinical assessment before discharge.

Patients in outpatient settings must be enrolled in the REMS program and have an enrolled caregiver/driver for transport home.

Pre-treatment blood pressure assessment is required; treatment should be reconsidered if systolic BP >140 mmHg or diastolic BP >90 mmHg before dosing.

Insurance Prior Authorization: What Most Plans Require

Prior authorization is required by virtually all major commercial insurers, Medicare Advantage plans, and most Medicaid programs. Standard documentation requirements across major payers include:

Diagnosis of TRD (MDD with inadequate response to 2+ oral antidepressants of adequate dose and duration) or MDD with acute suicidal ideation/behavior

Documentation of the 2+ failed antidepressant trials (drug name, dose, duration, reason for discontinuation)

Prescription from or in consultation with a psychiatrist (required by many payers including PA Medicaid)

No severe hepatic impairment (Child-Pugh class C)

Administration at a REMS-certified healthcare setting

Medicare Part B covers Spravato when administered in a REMS-certified facility, paying 80% of approved costs after the annual deductible. Medicare Part D may apply when dispensed through specialty pharmacy channels. Approval timelines typically range from several days to 2–4 weeks.

Dosing Schedule Reminder for 2026 Prescribers

For TRD: Induction is 56 mg or 84 mg intranasally twice weekly for 4 weeks. Maintenance starts at 56 mg or 84 mg once weekly for 4 weeks, then tapers to once weekly or once every 2 weeks. Dosing frequency should be individualized to the least frequent dosing that maintains remission.

For MDD with acute suicidal ideation or behavior: 84 mg twice weekly for 4 weeks (may reduce to 56 mg for tolerability). Always administer in conjunction with an oral antidepressant for this indication.

When to Consider Alternatives to Spravato

If Spravato is contraindicated, inaccessible, or not covered for your patient, consider these evidence-based alternatives:

TMS: FDA-cleared for MDD; widely covered; no systemic side effects; no REMS requirement

ECT: Most effective biological treatment for severe TRD; standard of care for life-threatening depression; covered by most insurers

Auvelity (dextromethorphan/bupropion): FDA-approved for MDD; oral; at-home use; faster onset than SSRIs/SNRIs; NMDA antagonism component

Medication augmentation: Atypical antipsychotics, lithium, thyroid hormone — standard of care for TRD before procedural options

Key Contraindications to Screen For

Screen patients for the following absolute contraindications before initiating Spravato:

Hypersensitivity to esketamine, ketamine, or any excipients

Aneurysmal vascular disease (thoracic or abdominal aorta, intracranial or peripheral arterial vessels) or arteriovenous malformation (risk of rupture from blood pressure elevations)

Severe hepatic impairment (Child-Pugh class C) — may lead to prolonged esketamine exposure

How medfinder Supports Your Patients' Medication Access

Your patients managing TRD often require multiple concurrent medications — oral antidepressants, mood stabilizers, anxiolytics, sleep aids — that can be hard to find at local pharmacies. medfinder for providers helps your patients locate pharmacies that have their full medication regimen in stock, reducing gaps in care caused by access issues.

See also our full guide: How to Help Your Patients Find Spravato In Stock: A Provider's Guide.