FDA Approves Ketamine for Treatment-Resistant Depression

Last Updated on September 17, 2026

Yesterday, on March 5, 2019, the FDA approved the use of ketamine for treatment-resistant depression. The new drug Spravato is a nasal spray that will only be available at specialty pharmacies, clinics, and doctor’s offices. Patients are not allowed to take it home with them. Although access to Spravato is highly restricted and it can only be administered by a medical professional, there are still risks involved.

Ketamine, a commonly abused club drug, is praised by drug users for its euphoric effects and “out-of-body” experiences, yet condoned by others for its ability to be used as a date rape drug. It’s also touted by some medical professionals as a miracle drug and treatment for depression. So which is it? Dangerous club drug or miracle drug? Here’s what you need to know about ketamine.

What is Ketamine?

Ketamine is classified as a dissociative anesthetic, which is a drug that has the ability to distort sight and sound, inhibit physical movement, and produce “out-of-body” experiences. A popular club drug and party pill, many users refer to ketamine by its street names or slang terms, which include:

• Special K
• K
• Cat valium
• Cat tranquilizer
• Jet K
• Kit Kat
• Purple
• Special La Coke
• Super acid
• Vitamin K¹

Aside from being a commonly abused club drug, ketamine does have legitimate medical uses. In fact, it is a well-established anesthetic drug that has been used to sedate people for medical procedures for the last 50 years or so.

Ketamine was used to treat wounded soldiers on the battlefield during the Vietnam war and it is still widely used by the U.S. military today, as it has been shown to reduce symptoms of PTSD among veterans.

In low doses, ketamine can relieve pain, depression, and reduce or even completely eliminate suicidal ideation very quickly. On the other hand, when it is abused, ketamine can cause hallucinations, increase heart rate and blood pressure, and potentially even cause fatal respiratory problems, among other harmful short-term and long-term side effects.

Is Ketamine Addictive?

Although it is effective in treating symptoms of deep depression and suicidal ideation, ketamine does have the potential to cause dependence and addiction, especially if it is used on a long-term basis.² A person who has developed a ketamine addiction may lose interest in their hobbies, isolate themselves from others, experience cravings, and be intensely preoccupied with using ketamine.

Other physical signs of ketamine addiction and abuse may include:

• Disorientation
• Drowsiness
• Difficulty concentrating
• Fatigue
• Lack of coordination or difficulty moving
• Slurred speech
• Skin redness
• Insomnia
• Bladder pain and/or incontinence

What are the Long-Term Effects of Ketamine?

Using ketamine on a long-term basis can result in several harmful side effects. In low doses, ketamine can help to relieve symptoms of severe depression, but when it is abused and taken in large and/or frequent doses, it can cause serious physical and psychological damage.

When people abuse ketamine to get high, they often describe it as “falling into a k hole.” This slang expression is used to describe the feelings of impairment and self-detachment they experience while they are high on the drug. Abusing ketamine can also result in euphoria, which may encourage a person to continue abusing it.

The risks of ketamine abuse are serious and include:

• Abnormal heartbeat
• Low blood pressure
• Difficulty breathing
• Seizures
• Abnormal movements
• Irreversible brain damage
• Date rape^3,4

There is very little research available regarding the long-term effects of ketamine, but one study found that chronic abuse of ketamine can cause verbal problems, short-term memory loss, and visual memory loss. It may also result in urinary problems and permanent brain damage.⁵

Who Abuses Ketamine?

Despite the unpleasant short-term and long-term side effects of ketamine, some people still abuse it due to the euphoric effects it provides and the “escape” from reality that a “k hole” experience offers.

Although many experiences using ketamine can definitely be unpleasant, at least 50 percent of ketamine users report experiencing pleasant effects like happiness, relaxation and an enhanced perception of the things around them.³ People who are struggling to cope with difficult life situations may also abuse ketamine regularly to escape the stress of everyday life, despite its negative effects.

Ketamine is classified by the FDA as a Schedule III drug and according to the National Survey on Drug Use and Health (NSDUH) young adults ages 18 and older are the most frequent abusers of ketamine and other hallucinogens like LSD, MDMA (Ecstasy), and NBOMe.^6,7 Ketamine first emerged as a recreational drug in the mid-1980s and continues to be abused by young adults in the party scene. Since its effects are felt quickly and they generally wear off in an hour or less, it is ideal for recreational abuse at clubs and raves.

Ketamine Treatment for Depression

On March 5, 2019, the FDA approved the use of a ketamine nasal spray to be prescribed for treatment-resistant depression. The drug was evaluated based on five different clinical trials, but only two of the studies showed significant positive results compared to a placebo.⁸

The drug esketamine will be sold under the brand name Spravato and will only be administered in a certified medical office under the direct supervision of a medical professional. Patients cannot take the drug home with them.

According to recent reports of the FDA-approval of Spravato, this new drug will be beneficial for people who suffer from treatment-resistant depression, but that population is a small one. The majority of people will not benefit from the drug.

While some doctors are fully onboard with ketamine treatment for depression, others are not. Some medical professionals argue that although the risks of prescribing ketamine for depression are real, so are the risks of untreated severe depression.

Regardless of its potential for abuse and addiction, ketamine clinics exist nationwide., giving rise to the view that ketamine is an effective and safe treatment for severe depression and suicidal behaviors. Many of these clinics provide ketamine infusion therapy, which is a series of IV infusions administered over several days.⁹ This type of treatment has not been thoroughly tested for long-term safety and effectiveness but experts say, based on the positive studies we do have, it shows promise for treating deep depression.

Medical experts aren’t exactly sure how ketamine works to treat depression, but they do know that it works differently than other popular antidepressant drugs like Celexa, , Prozac, and Cymbalta. According to a recent article from The Fix, Dr. Steven Mandel, president of the American Society of Ketamine Physicians, says ketamine treatment relieve his patients’ symptoms of depression 83 percent of the time and stops suicidal ideation more than 90 percent of the time.¹⁰

Risks of Using Ketamine to Treat Depression

When taking ketamine for any reason, whether recreational or medical, severe side effects may occur. Depending on the dosage taken, a user may:

• Have a severe allergic reaction
• Experience abnormal movements
• Experience dissociation (feel disconnected from yourself and your body)
• Have trouble talking
• Have low blood pressure and an irregular heartbeat
• Have difficulty breathing⁵

Although medical administration of the drug is safer than recreational ketamine abuse, it should still be used with caution and there is always a risk of dependence, abuse, and addiction.

Additionally, it’s important to recognize that ketamine is not a miracle drug and it won’t solve all your problems. Based on the research available, if you are suffering from severe depression and suicidal thoughts, ketamine infusion therapy or the recently-approved Spravato may temporarily help relieve the symptoms of depression and stop suicidal ideation, but ongoing therapy is necessary to address the root causes of the psychological problems.

Help for Ketamine Addiction

If you are suffering from ketamine addiction and depression, your substance abuse could be contributing to your mental health issues. If you need help to recover from addiction, drug detox and long-term rehab can provide comprehensive, ongoing care and behavioral therapy to eliminate drug-abusing behaviors and address the root causes of your addictive behaviors and co-occurring disorders like depression. Call Nova Recovery today to learn more about our 90-day drug rehab program and aftercare services.

References:

1. https://drugfree.org/drug/ketamine/
2. https://www.rxlist.com/ketamine-hydrochloride-side-effects-drug-center.htm#professional
3. https://www.verywellmind.com/what-is-a-k-hole-21861
4. https://drugfree.org/drug/ketamine/
5. https://www.verywellmind.com/basic-facts-about-ketamine-67495
6. https://www.dea.gov/drug-scheduling
7. https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.pdf
8. https://onezero.medium.com/the-party-drug-that-could-help-stop-depression-2e57c195b294
9. https://www.thefix.com/club-drug-ketamine-nears-fda-approval-depression-treatment

Fact-Checked Ketamine Information: FDA Approval & Clinical Evidence

Last Updated: August 2026

This section reflects current FDA guidance and clinical evidence as of August 2026. All claims below are sourced to official FDA approvals, SAMHSA clinical guidelines, and peer-reviewed research.

FDA Approval Timeline & Official Status

• Esketamine (Spravato®): FDA-approved March 2019 for treatment-resistant depression (TRD) in adults. Nasal spray administered in clinical settings only.
• Ketamine (IV): FDA-approved for anesthesia (1970); off-label use in TRD is clinically recognized but not formally FDA-approved as a psychiatric treatment. Clinical use follows published protocols from major medical centers and SAMHSA guidelines.
• Source: FDA.gov – Center for Drug Evaluation and Research (CDER) product approvals; FDA Press Release, March 5, 2019

How Ketamine Works in Treatment-Resistant Depression

Unlike traditional antidepressants (SSRIs, SNRIs) that target serotonin and norepinephrine, ketamine works through the glutamate system:

• Blocks NMDA receptors on glutamate neurons, increasing synaptic glutamate
• Activates AMPA receptors, promoting neuroplasticity
• Produces rapid effects: symptom relief can occur within hours to days (vs. weeks for traditional antidepressants)
• May reduce suicidal ideation acutely
• Clinical Evidence: Multiple randomized controlled trials confirm efficacy; see PubMed / MEDLINE for peer-reviewed literature (keywords: “ketamine treatment-resistant depression RCT”)

Who Is a Candidate for Ketamine Treatment?

Ketamine-based therapies are typically considered when:

• A person has failed 2 or more adequate trials of different antidepressant classes
• Depression is severe and causing functional impairment or suicide risk
• Rapid symptom relief is needed
• Traditional medications are ineffective or intolerable

Medical Review: All candidates must undergo comprehensive psychiatric and medical evaluation by a licensed psychiatrist or addiction medicine physician before treatment begins.

Treatment Protocols & Safety

Esketamine (Spravato®):

• Administered under medical supervision in a clinic or hospital
• Typical dosing: 56 mg or 84 mg intranasal, twice weekly initially, then weekly or biweekly
• Requires 2-hour post-dose medical monitoring (dissociation, blood pressure changes)
• REMS program mandates: enrollment, clinic certification, patient risk assessment
• Source: FDA Spravato Safety Page

IV Ketamine (Off-Label):

• Administered in specialty clinics or hospital settings
• Typical dosing: 0.5–1 mg/kg IV over 40 minutes, 2–3 times per week
• Duration varies; many require ongoing maintenance doses
• Off-label use follows published protocols (e.g., from Yale School of Medicine, UC San Diego) but is not formally FDA-approved for psychiatry

Side Effects & Contraindications

Common Side Effects:

• Dissociation, dizziness, nausea (usually mild and temporary)
• Increased blood pressure and heart rate (monitored during treatment)
• Headache, sedation

Serious Risks (Rare):

• Substance use disorder risk (due to ketamine’s potential for misuse); requires careful screening and monitoring
• Psychosis or worsening mood symptoms in vulnerable individuals
• Blood pressure emergency (hypertensive crisis) in uncontrolled hypertension

Contraindications:

• Uncontrolled or severe hypertension
• Active psychosis or untreated schizophrenia
• Cardiac arrhythmias or severe heart disease
• Current substance use disorder (especially stimulants or dissociatives)
• Severe or unstable medical illness

All contraindications are assessed by a licensed psychiatrist during intake evaluation.

Nova Recovery Center’s Approach to Ketamine & Dual Diagnosis

Ketamine treatment for depression requires rigorous medical oversight, especially for individuals with co-occurring addiction or substance use history. Our inpatient and outpatient programs integrate:

• Psychiatric Assessment: Board-certified psychiatrists screen for treatment-resistant depression, dual diagnosis, and substance use risk
• Medical Clearance: Physical exam, labs, and cardiac monitoring where indicated before ketamine initiation
• Behavioral Therapy: Concurrent psychotherapy (CBT, DBT, motivational interviewing) maximizes treatment response
• Addiction Monitoring: For clients with substance use history, we maintain heightened vigilance during ketamine therapy and monitor for relapse risk
• Monthly Clinician Review: All ketamine-treated clients are reviewed by our clinical team monthly to ensure factual accuracy of protocols and compliance with current FDA/SAMHSA guidelines

If you or a loved one is struggling with treatment-resistant depression, especially alongside addiction or mental health challenges, our team can assess whether ketamine therapy is appropriate and connect you to evidence-based care.

Frequently Asked Questions

Is ketamine addiction treatment the same as ketamine for depression?

No. Ketamine-assisted therapy for depression targets treatment-resistant mood disorder in a medical setting with psychiatric supervision. Ketamine is NOT used as a primary addiction treatment at Nova Recovery Center. We treat alcohol, opioid, stimulant, and other substance use disorders through residential and outpatient behavioral and medical interventions.

How long does ketamine treatment for depression last?

Initial induction typically lasts 4–8 weeks (8–12 infusions or esketamine doses). Many people then require maintenance doses (weekly to monthly) to sustain benefits. Duration is individualized based on response and relapse risk. Your psychiatrist will establish a treatment plan during your intake assessment.

Can ketamine be used if I have a history of substance use disorder?

Careful screening is required. People with active substance use, high relapse risk, or stimulant/dissociative use disorder may not be candidates for ketamine due to abuse potential. Our intake process includes comprehensive addiction and psychiatric evaluation to determine safety and alternatives if ketamine is not appropriate.

What is the difference between esketamine (Spravato®) and IV ketamine?

Esketamine is the S-enantiomer of ketamine, FDA-approved for TRD, and administered as a nasal spray in a clinic setting under REMS. IV ketamine is racemic (equal mix of S and R enantiomers), used off-label for TRD, and administered intravenously. Both require medical supervision; esketamine has formal FDA labeling for psychiatry, while IV ketamine is based on published clinical protocols. Efficacy and tolerability vary individually.

Does ketamine treatment work for bipolar depression?

Research on ketamine in bipolar disorder is emerging but limited. Rapid-acting antidepressants carry some risk of mood cycling or switching in bipolar disorder. Individuals with bipolar depression require specialized psychiatric evaluation before ketamine is considered. Nova’s psychiatrists assess each person individually and may recommend alternative or adjunctive treatments.

How do I know if ketamine treatment is right for me?

Start with a comprehensive psychiatric evaluation. Ketamine is typically considered if you have: (1) failed 2+ adequate antidepressant trials, (2) severe, disabling depression, (3) suicide risk, or (4) need for rapid symptom relief. Call Nova Recovery Center at (512) 893-6955 to speak with a psychiatrist about whether ketamine is appropriate for your situation.

Related Resources & Further Reading

• FDA Spravato (esketamine) Official Page: FDA.gov – Spravato Safety & Efficacy
• SAMHSA Clinical Guidelines: SAMHSA Treatment Locator & Evidence-Based Practices
• PubMed Ketamine Research: Search “ketamine treatment-resistant depression” on PubMed
• Nova Recovery Services: Understanding Dual Diagnosis & Co-Occurring Disorders
• Depression & Addiction: Depression & Mental Health in Addiction Recovery
• Finding the Right Treatment: How to Find the Right Rehab Facility for Your Needs

Disclaimer: This content is educational and does not replace consultation with a licensed healthcare provider. Ketamine treatment decisions must be made with a board-certified psychiatrist or qualified addiction medicine physician after thorough evaluation. All medical information is current as of August 2026 and reflects FDA guidance and peer-reviewed clinical evidence available at that date.