FDA-Approved Depression Treatments: Understanding TMS and Esketamine (Spravato)

Knowing a therapy is FDA-approved gives you confidence in its safety, oversight, and evidence base - but what does that really mean, and how does it apply to two leading options we offer at our clinic: TMS and Esketamine (Spravato®)? This guide walks you through what FDA approval means in mental-health care, how each treatment works, who qualifies, risks and benefits, and how to decide which path is right for you.

What “FDA-Approved” Really Means for Mental-Health Treatments

The phrase “FDA-approved” carries significant meaning in the realm of mental-health care. When a treatment receives clearance or approval from the U.S. Food and Drug Administration (FDA), it means that the agency has evaluated evidence showing the treatment is safe and effective for a specific indication in a defined patient population.

That definition matters: many therapies may be used off-label, but FDA approval signals a higher level of regulatory review, standardized manufacturing, and defined protocols for use.

In the context of depression and related disorders, an FDA-approved therapy means device platforms or medications have been tested in rigorous clinical trials, their benefits outweighed risks under defined conditions, and post-marketing monitoring is in place. Practically, approval often enables better insurance coverage, more clinician confidence, and access under supervised conditions.

It also means that the approval is indication-specific - the FDA may clear a device (e.g., a TMS system) for a defined type of major depressive disorder (MDD), or approve a drug (e.g., nasal esketamine) for treatment-resistant depression. Patients and clinicians should always check the approved indication, monitoring requirements, and whether the facility offering the therapy is certified to deliver it. For example, certain drugs are available only through REMS programs.

By focusing on FDA-approved therapies, you’re aligning with treatments that have met regulatory benchmarks. At our clinic, we offer only FDA-cleared/approved options, so you can be confident in the evidence base and oversight behind the care.

FDA-Approved Therapy #1 – TMS (Transcranial Magnetic Stimulation)

Transcranial Magnetic Stimulation (TMS) is a non-invasive, FDA-cleared brain-stimulation therapy that uses magnetic pulses to stimulate nerve cells in regions of the brain involved in mood regulation (Mayo Clinic). A coil is placed on the scalp, generating targeted magnetic fields that help activate under-performing neural circuits associated with depression.

TMS was first cleared by the FDA in 2008 for major depressive disorder (MDD) in adults. Since then, additional devices, coil types, and protocols have been cleared—including modern, shorter-treatment protocols and expanded age eligibility.

Modern TMS Protocols at Our Clinic

At our clinic, we deliver TMS using the latest FDA-cleared systems. Modern protocols are significantly shorter than early-generation treatments:

• Theta Burst (iTBS): under 4 minutes per session
  
  
• Standard rTMS: typically 10–20 minutes
  
  
• Older 37-minute protocols: no longer used
  
  

A full FDA-cleared TMS course consists of 36 sessions, delivered as daily weekday treatments across 7 to 9 weeks. This is the standard protocol recognized and approved by insurers. While accelerated protocols such as SAINT show promise, these are not currently covered by managed care, so we follow the evidence-based, insurance-approved standard course.

Effectiveness and Clinical Outcomes

TMS offers a well-tolerated, non-systemic alternative for patients who have not improved with medications. Clinical studies consistently show:

• 50–70% response rates
  
  
• 30–50% remission rates
  
  
• Significant improvements in PHQ-9 and other standardized depression scores
  
  

These outcomes are notable in patients who have previously failed one or more antidepressants.

Safety Profile

As a device-based therapy, TMS has a favorable safety profile:

• Most common effects: mild scalp discomfort or headache
  
  
• Rare risk: seizure, minimized through careful screening
  
  
• No systemic effects or medication-related side effects
  
  

For many patients, TMS provides a non-medication pathway toward recovery when traditional pharmacologic options have been exhausted.

FDA-Approved Therapy #2 – Esketamine (Spravato®) Nasal Spray

Esketamine (brand-name Spravato®) is a nasal-spray antidepressant derived from ketamine (its S-enantiomer) but formulated and regulated differently. Unlike traditional antidepressants that act on serotonin or norepinephrine, esketamine works on the glutamate system - a newer mechanism in mood disorders.

The FDA initially approved Spravato in March 2019 for adults with treatment-resistant depression (TRD) in conjunction with an oral antidepressant (FDA Approval Summary). Recently (January 2025), the FDA expanded its approval to allow Spravato as a monotherapy (stand-alone treatment) for adults with major depressive disorder (MDD) who have not responded adequately to at least two oral antidepressants (UTHealth Houston).

At our clinic, Spravato is administered under strict supervision: the patient self-administers the nasal spray in a certified treatment environment and remains under observation for at least two hours due to risks such as sedation, dissociation, and respiratory depression (FDA REMS Label).

Candidate patients are those who have failed multiple antidepressant trials (and possibly also those with suicidal thoughts or behavior, under specific protocols). We conduct a comprehensive evaluation, ensure patient safety (monitor blood pressure, screen for substance use), and provide the required monitoring infrastructure.

While outcomes can be rapid - some patients report symptom reductions within 24 hours - esketamine requires ongoing monitoring, and long-term benefits and durability vary.

Because it is a controlled substance (Schedule III) and part of a REMS (Risk Evaluation and Mitigation Strategy) program, Spravato can only be delivered in certified clinics and is typically covered under specific insurance criteria. The cost, frequency of treatments, and insurance coverage should be discussed in advance.

Comparing TMS & Esketamine: Choosing the Right Option

When considering FDA-approved therapies for depression such as TMS and esketamine, it’s helpful to compare how they differ so you can see which may align better with your clinical profile and preferences.

• Indication/Modality: TMS is a device-based neuromodulation treatment; esketamine is a pharmacologic nasal spray. Both are FDA-approved for depression, but the exact indications differ (e.g., TRD vs broader MDD).
  
  
• Treatment setting & commitment: TMS typically requires daily or accelerated clinic visits over several weeks. Esketamine also requires in-clinic administration and monitoring (minimum 2 hours post-dose), so both involve time in a clinical setting - but the frequency, duration, and logistics differ.
  
  
• Onset of effect: Esketamine has been shown to produce relatively rapid symptom relief (some within a day). TMS benefits may accumulate over weeks.
  
  
• Safety/side effect profiles: TMS side effects are mostly regional (scalp discomfort, headaches, rare seizure); esketamine’s risks include sedation, dissociation, respiratory depression, and misuse/abuse potential (hence the REMS program).
  
  
• Insurance & cost: Both being FDA-approved enhances eligibility for coverage, but device therapy and novel pharmacologic therapy may differ in cost structures, insurance prior-authorization, number of sessions, etc.
  
  
• Fit for patient history: If a patient has failed multiple medications and desires a non-systemic option, TMS may be appealing. If more rapid relief is needed, or medications have been largely ineffective, esketamine might be considered.
  
  

Our clinical team at Sacramento NeuroPsych Associates will assess your history, preferences, and medical condition to recommend the optimal path. Schedule your consultation →

What to Do Next - Getting Evaluated at Our Clinic

If you are exploring FDA-approved depression treatments, here’s how you can proceed at our clinic.

First, schedule a consultation. During the intake, we’ll review your medical and mental-health history, previous treatments (medications, therapy, devices), and current symptoms. We’ll determine whether you meet criteria for TMS or esketamine (or both) and discuss risks, benefits, logistics, and expected time-frames. We’ll also review insurance coverage and cost estimates.

If you proceed, we’ll schedule baseline testing (if needed), consent, and treatment planning. Our goal is to deliver safe, evidence-based, FDA-approved care tailored to your needs.

By choosing a clinic that offers only FDA-cleared/approved therapies, you’re opting for treatments with regulatory backing, standardized protocols, and oversight that protects your safety and outcomes. Let’s begin the path to relief together.

Frequently Asked Questions

Q: What does “FDA-approved” mean for depression treatments?
A: It means the therapy has gone through the FDA’s review process for safety and effectiveness for a specific condition and is being marketed for that indication.

Q: Is TMS FDA-approved for depression?
A: Yes - TMS was first cleared by the FDA in 2008 for major depressive disorder. (FDA)

Q: Is esketamine (Spravato®) FDA-approved?
A: Yes - it was originally approved in 2019 for treatment-resistant depression and in 2025 its approval was expanded to allow monotherapy use in adults with major depressive disorder. (UTHealth Houston)

Q: Who is eligible for these treatments?
A: Eligibility varies by treatment; typically someone who has tried and not responded sufficiently to other antidepressant therapies is a candidate - our clinic will evaluate your medical history and current status.

Q: Are these treatments safe? What are the risks?
A: Both have safety profiles: TMS is generally well-tolerated with mild scalp/headache side effects; esketamine involves monitoring for sedation, dissociation, and respiratory issues and is managed via a REMS program. (FDA Label 2020)

Q: How do I choose between TMS vs esketamine?
A: The choice depends on your treatment history, how fast relief is needed, treatment logistics (clinic visits vs monitoring), safety profile, and personal preference. Discuss with your provider.

Q: Will my insurance cover these treatments?
A: Many insurers cover FDA-approved therapies, but coverage may vary based on your plan, prior treatment history, and documented need. Our clinic’s intake will include insurance review.

Q: How long does each treatment take to work?
A: Esketamine may produce relief in as little as 24 hours in some cases. TMS effects generally build over several weeks of daily or accelerated sessions. (Mayo Clinic)

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