Ketamine Nasal Spray Approved by FDA: A Breakthrough for Treatment-Resistant Depression

Depression affects over 16 million Americans, and while many find relief with conventional antidepressants, millions don’t. For those with treatment-resistant depression, life can feel like a constant cycle of hopelessness, emotional numbness, and failed treatments. But for the first time in over 30 years, a new class of antidepressant has emerged — and it’s changing the landscape of mental health care.

Meet Spravato, a nasal spray version of esketamine, developed by Johnson & Johnson and recently approved by the U.S. Food and Drug Administration (FDA). It’s fast-acting, backed by cutting-edge neuroscience, and specifically formulated for people who haven’t responded to at least two other antidepressants.

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 What Is Esketamine and How Does It Work?

Esketamine is a chemical variant of ketamine, a well-known anesthetic that has been used in operating rooms for decades. Ketamine has also been misused recreationally under the street name “Special K”, due to its dissociative, psychedelic effects. But under medical supervision and in low doses, ketamine has shown extraordinary promise in treating major depressive disorder (MDD), especially in patients who haven’t responded to conventional antidepressants.

Unlike standard drugs like SSRIs (e.g., Prozac) or SNRIs (e.g., Effexor) that influence serotonin, norepinephrine, or dopamine, esketamine targets glutamate — the brain’s most abundant neurotransmitter. Glutamate plays a critical role in neuroplasticity, which allows the brain to form new neural connections and “rewire” itself — crucial in combating depression.

Dr. Dennis Charney, a leading neuroscientist and dean at the Icahn School of Medicine at Mount Sinai, called Spravato “a potential game changer” for millions who have long struggled without results.

 Why Is Esketamine So Important?

1. Fast-Acting Relief

Traditional antidepressants can take 4–6 weeks to show benefits — a timeline that can feel unbearable for someone facing severe depression or suicidal thoughts. Esketamine, by contrast, often begins to work in just hours or days. Clinical trials and patient reports have shown rapid mood improvements, sometimes even after the first dose.

2. New Hope for Treatment-Resistant Depression

Spravato is approved specifically for patients who have failed at least two other antidepressants. This group represents nearly one-third of all people with depression — people who often feel forgotten by the healthcare system.

“When you haven’t responded to available treatments and you’ve been suffering for years, this can be a deadly disease,” says Dr. Charney.

 How Esketamine Differs from Ketamine

Esketamine is the S-enantiomer of ketamine, meaning it’s one of the two mirror-image molecules that make up the ketamine compound. Some studies suggest that esketamine is more potent and requires lower doses to achieve similar effects. However, generic ketamine, often delivered intravenously (IV), remains widely used in off-label depression treatment.

Esketamine offers a few key differences:

• FDA approval for depression
• Nasal spray delivery instead of IV infusion
• Monitored use in certified medical centers
• More expensive than generic ketamine
• Limited long-term data compared to decades of ketamine use

 Side Effects and Safety Concerns

Because esketamine is chemically related to a controlled substance, the FDA has implemented a Risk Evaluation and Mitigation Strategy (REMS). This means:

• Patients cannot take the medication at home
• Doses must be administered in-person at a certified clinic
• A trained provider must monitor the patient for at least 2 hours
• Patients must avoid driving or operating machinery for the rest of the day

Potential side effects of esketamine include:

• Dissociation (feeling detached from self or surroundings)
• Dizziness or confusion
• Nausea and vomiting
• Sedation
• Elevated blood pressure
• Risk of misuse or addiction
• Suicidal thoughts or behaviors (a known risk with all antidepressants)

These risks are closely monitored, and patients are thoroughly screened before beginning treatment.

 The Cost of Spravato: Is It Worth It?

Spravato is not cheap. Johnson & Johnson has priced the treatment at:

• 💲$590 to $885 per dose, depending on the strength
• 💲$4,720 to $6,785 for the first month (typically 2 doses per week)
• 💲Half the cost in later months (once-weekly maintenance)

These costs do not include provider fees for monitoring, administration, or facility overhead. In contrast, many IV ketamine clinics charge about $400–$600 per infusion, though this is often not covered by insurance.

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What Do the Clinical Trials Say?

The FDA based its approval of esketamine on five clinical trials, including:

• A short-term study showing rapid symptom improvement
• A relapse prevention trial confirming long-term effectiveness in responders

However, only two of the five studies showed statistically significant results. A key study in patients over age 65 did not meet significance, raising concerns about its efficacy in elderly populations.

Dr. Amit Anand, Vice Chair for Research at the Center for Behavioral Health, notes:
“We still don’t fully understand the long-term effects of interfering with glutamate systems. That’s why this treatment is reserved for the most severe cases.”

 Ketamine Clinics and Off-Label Use

Before Spravato’s approval, ketamine had already been used off-label by many psychiatrists and ketamine infusion clinics. These clinics often administer generic ketamine intravenously, with patients reporting profound mood improvements after just a few sessions.

Dr. Demitri Papolos, a long-time advocate of ketamine therapy, welcomed the FDA’s approval but emphasized that generic ketamine may be more affordable and effective. He also cautions that Spravato’s restrictions and costs could limit access.

 When Should You Consider Ketamine Nasal Spray?

Spravato is designed for adults with treatment-resistant depression. It may be appropriate if:

• You’ve tried two or more antidepressants without relief
• You’re experiencing severe, persistent depression
• You need rapid relief due to suicidal thoughts or intense suffering
• You’re seeking an alternative to ECT or rTMS
• You are open to being treated in a clinical setting on a weekly basis

If you’re unsure whether esketamine or generic ketamine is right for you, consult a psychiatrist familiar with both.

Hope, with Caution

The FDA’s approval of esketamine nasal spray is a historic breakthrough in the treatment of depression. While not a cure-all, it introduces a new, fast-acting, and science-backed option for those who have been left behind by traditional medications.

Still, it comes with caveats: cost, supervised dosing, and potential side effects. More research is needed to determine its long-term safety and effectiveness across diverse patient populations.

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 If You or a Loved One Is Struggling with Depression

Don’t wait. Seek professional help from a psychiatrist, psychologist, or mental health provider. In crisis? Contact a local emergency number or a mental health crisis line in your area.