Spravato is a brand-name prescription medication that's prescribed for treatment-resistant depression (TRD). TRD is depression that hasn't improved after treatment with two or more antidepressants.
Spravato contains the drug esketamine. It's approved for use in adults, but not in children.
Spravato comes as a nasal spray. It's taken under the supervision of a healthcare provider at a certified medical facility. Spravato should be used in combination with at least one other antidepressant medication that's taken by mouth.
In a clinical study lasting four weeks, Spravato improved symptoms of depression in people taking the drug. One group was given Spravato and an oral antidepressant. The other group was given a placebo (no treatment) and an oral antidepressant. Depression symptoms were measured on a scale of zero to 60 (with higher scores meaning worse depression symptoms).
People taking Spravato had fewer depression symptoms than people taking the placebo. Scores for people taking Spravato improved by 4 points more than scores for people taking the placebo. The greatest improvement in symptoms was seen in the first 24 hours after people took Spravato.
Spravato was approved by the Food and Drug Administration (FDA) in March 2019.
Its approval is considered controversial by some people for a few reasons:
Long-term studies are still being done regarding how safe and effective Spravato is. The results of these studies will be helpful for doctors managing TRD.
Yes, Spravato is a controlled substance. It's classified by the FDA as a schedule three (III) drug. This means that Spravato is accepted for medical use, but has a high risk of dependence. Spravato has the potential to be misused.
The U.S. government passed laws to govern how controlled substances are prescribed and dispensed. Your doctor or pharmacist can tell you more about these laws.
Spravato is available only as a brand-name medication. It's not currently available in generic form.
Spravato contains the drug esketamine.
Spravato is approved by the Food and Drug Administration (FDA) to treat a form of depression called treatment-resistant depression (TRD). It's approved for use in adults, in combination with at least one other antidepressant drug that's taken by mouth.
TRD is a type of depression that hasn't improved after you've tried at least two different antidepressant medications. Your doctor will determine if you have TRD based on your use of other antidepressants.
The Food and Drug Administration (FDA) approves prescription drugs such as Spravato to treat certain conditions. Spravato may also be used off-label for other conditions. Off-label use is when a drug that's approved to treat one condition is used to treat a different condition.
Spravato is FDA-approved to treat a form of depression called treatment-resistant depression (see 'Spravato for depression' above). It's approved for use in adults, in combination with at least one other antidepressant that's taken by mouth.
In a clinical study lasting four weeks, Spravato improved symptoms of depression in people taking the drug. One group was given Spravato and an oral antidepressant. The other group was given a placebo (no treatment) and an oral antidepressant. Depression symptoms were measured on a scale of zero to 60 (with higher scores indicating worse depression symptoms).
People taking Spravato had fewer depression symptoms than people taking the placebo. Scores for people taking Spravato improved by 4 points more than scores for people taking the placebo. The greatest improvement in symptoms was seen in the first 24 hours after people took Spravato.
After the four-week trial, some people enrolled in a year-long study. These were people who had a significant improvement in their depression symptoms during the first study.
In the year-long study, Spravato also improved depression symptoms. During this study, people were taking an oral antidepressant with either Spravato or a placebo nasal spray. Those who took Spravato were 51% to 70% less likely to relapse back to severe depression than those taking the placebo.
You may wonder if Spravato is used to treat other mental health conditions. Spravato hasn't been FDA-approved to treat the conditions described below.
Spravato for anxiety (not an appropriate use)
Spravato isn't approved to treat anxiety. Clinical studies haven't looked at the use of Spravato for this purpose, but studies may take place in the future.
However, ketamine (a drug similar to Spravato) has been studied for use in treating anxiety disorders. These disorders include social anxiety disorder, anxiety in adolescents, and refractory anxiety. Some of these studies have shown promising results, but it's not known if similar results would be seen with Spravato.
More research is needed to know whether Spravato or ketamine are safe or effective for treating anxiety.
Spravato for OCD (not an appropriate use)
Spravato isn't approved to treat obsessive-compulsive disorder (OCD). No clinical studies have been done that would show whether Spravato is effective for treating OCD.
Ketamine (a drug similar to Spravato) has been looked at in several clinical studies as a treatment for OCD. Results in these studies were conflicting. It's not known whether similar results would be seen with Spravato as a treatment for OCD.
More studies are needed to know whether Spravato or ketamine are safe or effective for OCD treatment.
Spravato can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Spravato. This list does not include all possible side effects.
For more information on the possible side effects of Spravato, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.
The more common side effects of Spravato can include:
Most of these side effects may go away within a few hours to a couple days. If they're more severe or don't go away, talk to your doctor or pharmacist.
Serious side effects from Spravato aren't common, but they can occur. Call your doctor right away if you have serious side effects after leaving the doctor's office. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.
Serious side effects and their symptoms can include the following:
* These effects can also occur in children. This drug is not approved for use in children.
You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here's some detail on certain side effects this drug may cause.
As with most drugs, some people can have an allergic reaction after taking Spravato. It's not known how often this occurs in people taking Spravato. Symptoms of a mild allergic reaction can include:
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:
You will stay in the doctor's office for at least two hours after you take Spravato. Your healthcare provider will monitor you for side effects or allergic reactions.
Call your doctor right away if you have a severe allergic reaction to Spravato after leaving the office. Call 911 if your symptoms feel life-threatening or if you think you're having a medical emergency.
Dissociation was one of the most common side effects seen during clinical trials of Spravato. This condition is a change in your mental state. It's often described as having an 'out-of-body' experience. People can feel disconnected from time, space, or their own body or mind.
Symptoms of dissociation can include:
In clinical trials of Spravato, between 61% and 75% of people taking the drug had symptoms of dissociation. These symptoms, which were temporary, occurred on the day Spravato was taken. Dissociation was more common in people ages 65 years and older. It was also more common in people taking higher doses than in people taking lower doses of the drug.
In clinical studies, only 0.4% of people stopped taking Spravato because of dissociation symptoms.
During your appointment to receive Spravato, your healthcare provider will monitor you for at least two hours after you take the drug. They will check you for side effects including dissociation. They'll let you know when it's safe for you to go home.
Some people have a greater risk of dissociation after taking Spravato. If you have a history of psychosis, you may be at increased risk. Talk with your doctor about whether Spravato is safe for you.
Sedation was a common side effect seen in clinical studies of Spravato. Symptoms of sedation include extreme sleepiness, having trouble thinking, and a decreased ability to respond.
In clinical studies, sedation was more common in:
Only 0.3% of people actually lost consciousness after taking Spravato in the studies. This means there was a short period where they didn't respond when their healthcare provider tried to wake them.
Some medications taken with Spravato can also cause symptoms of sedation. People using these medications may be at increased risk of sedation.
After taking Spravato, you'll stay in the healthcare facility for at least two hours. Your doctor will monitor you for symptoms of sedation. They will advise when you can safely go home. You'll need a trusted friend or family member to drive you home. You shouldn't drive or operate heavy machinery until after you've had a full night's sleep.
Increased blood pressure was seen in people taking Spravato during clinical studies. Up to 17% of people who took Spravato had increased blood pressure. The blood pressure changes seen within 1.5 hours of taking Spravato included:
Your doctor will check your blood pressure before you take Spravato. If your blood pressure is high, they may recommend that you wait to take your dose of Spravato. You and your doctor can weigh the benefits and risks of using this drug at that time.
Your doctor will also check your blood pressure about 40 minutes after you take Spravato. They will have you stay at the healthcare facility at least two hours after taking Spravato. If your blood pressure is high after you take the drug, you may need to stay at the facility longer for monitoring or possible treatment.
If you have uncontrolled high blood pressure before starting Spravato, your doctor may decide that you shouldn't use this drug. (For more information, see 'Spravato warnings' below.)
The Spravato dosage your doctor prescribes will depend on how your body responds to Spravato.
Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that's right for you. They'll ultimately prescribe the smallest dosage that provides the desired effect.
The following information describes dosages that are commonly used or recommended. Your doctor will determine the best dosage to suit your needs.
Spravato comes as a nasal spray. It's given through a special device that sprays the drug into your nose. Each device delivers two sprays of the medication. Each spray contains 14 mg of Spravato.
Depending on the dose your doctor prescribes, you will need to use either two or three devices each time you take Spravato.
The dosage for Spravato is given in two phases: An induction (starting) phase and a maintenance (ongoing) phase.
Each dose of Spravato is taken under the supervision of your healthcare provider at a certified medical clinic. Your blood pressure will be checked before you take the drug, and you'll be monitored for side effects for at least two hours after you take Spravato.
The induction phase lasts for the first four weeks of Spravato treatment. During this phase, you'll take the drug two times each week.
The first dose of Spravato is 56 mg. Each dose after that is either 56 mg or 84 mg. Your doctor will prescribe your dose based on how well your body tolerates the drug.
At the end of the induction phase, you and your doctor will discuss whether you should continue to the maintenance phase. This decision depends on how well the drug works for you and if you're tolerating any side effects.
The maintenance phase starts at the beginning of week 5 of using Spravato. During week 5 through week 8, you'll take Spravato once each week.
During week 9 and after, you'll take Spravato either once weekly or twice weekly.
The dose during the maintenance phase is either 56 mg or 84 mg. Your doctor will advise how often you should use Spravato. This depends on how well your body tolerates the medication and if your symptoms improve. Ultimately, your doctor will prescribe the lowest dose that's effective for you.
If you miss an appointment for a Spravato dose, call your doctor's office as soon as you remember. They will reschedule your appointment. They may also adjust your upcoming appointments to better fit your schedule. This helps you maintain a safe and effective dosing schedule.
It depends. Your doctor may recommend that you take Spravato on a long-term basis if it's safe, effective, and necessary for you. You and your doctor will make this decision together.
As with all medications, the cost of Spravato can vary. Your doctor's office will purchase Spravato from a specialty pharmacy. Spravato isn't available for you to purchase at a pharmacy.
Spravato may be covered by your prescription insurance coverage or your medical insurance coverage. This will depend on your specific insurance plan.
If you need financial support to pay for Spravato, or if you need help understanding your insurance coverage, help is available.
Janssen, the manufacturer of Spravato, offers a program called Janssen CarePath. For more information and to find out if you're eligible for support, call 844-777-2828 or visit the program website.
Spravato is taken as a nasal spray that you'll administer yourself. You will take the drug at a certified medical facility. Your doctor will show you how to use the nasal spray device. They'll also monitor you while you take Spravato to make sure you don't have any problems using the device.
You will be asked to blow your nose before you take the first spray of Spravato. This is done to make sure the medication is not blocked by any congestion inside your nose.
Your healthcare provider will provide the correct number of devices needed for your treatment. The number of devices you'll use depends on your specific dose. Each nasal spray device contains 28 mg of Spravato. If your dose is 56 mg, you'll need to use two devices. If your dose is 84 mg, you'll use three Spravato devices.
Your doctor will show you how to use the nasal spray device. Before you take the dose, you'll recline to about a 45-degree angle. This helps the medication stay inside your nose so that your body can absorb it.
Your healthcare provider will monitor you while you're taking Spravato. They'll continue to watch you for at least two hours after your dose. This monitoring is done to make sure that you have no serious side effects after your treatment. Your doctor will advise when you can safely leave the clinic.
You'll need to have someone drive you home after your Spravato treatment. You shouldn't drive after taking the drug. You should also avoid taking part in activities that require coordination and mental alertness. You can usually resume all of your normal activities the day after your Spravato treatment.
Spravato is taken once or twice per week. Your doctor will recommend the dosing schedule that's best for you.
Spravato may cause nausea or vomiting in some people. To help prevent these side effects:
Depression is a complicated mood disorder. It's thought to be caused in part by imbalanced levels of neurotransmitters in your brain. Neurotransmitters are chemical messengers in your body that help nerves communicate with each other. Examples of neurotransmitters include serotonin and dopamine.
Neurotransmitter levels can become imbalanced if they increase or decrease in activity. This can affect the body's ability to function properly. Moods and mental well-being can be affected by imbalance in neurotransmitter levels. These imbalances may also be related to depression.
It's not known exactly how Spravato helps improve depression symptoms. It may be related to how Spravato interacts with neurotransmitters.
Spravato blocks a neurotransmitter called glutamate from binding to a certain receptor (attachment site) on your nerves. The blocked receptor is called NMDA (N-methyl-D-aspartate) receptor. Blocking glutamate from attaching to this receptor may help regulate communication between nerve cells in the brain. This may help improve symptoms of depression.
Spravato starts working very quickly. In clinical studies, many people who took Spravato felt improved depression symptoms within four hours of taking the drug.
Other drugs are available that can treat your condition. Some may be better suited for you than others. If you're interested in finding an alternative to Spravato, talk to your doctor to learn more about other medications that may work well for you.
Note: Some of the drugs listed here are used off-label to treat this condition.
Depression is a very complicated disease that we're still learning about. Because of its complexity, treating depression is often a process of trial and error. You may need to try several different medications before you find one that helps improve your symptoms.
There are many different medications available to treat depression. The following are examples of other drugs that may be used for depression, including treatment-resistant depression (TRD):
Spravato is approved for use in combination with other antidepressant medications. It should always be used with at least one other antidepressant that's taken by mouth.
There are many different antidepressant medications that can be used with Spravato. Many of the treatment options listed above in 'Alternatives to Spravato' can also be taken with Spravato.
You may wonder how Spravato compares to other medications that are prescribed to treat treatment-resistant depression (TRD). Below are comparisons between Spravato and other medications.
Spravato contains the drug esketamine. Abilify contains the drug aripiprazole. These medications belong to different drug classes, but they're both used to treat depression.
Spravato is approved to treat a form of depression called treatment-resistant depression (TRD) in adults. It's approved for use in combination with at least one other antidepressant medication that's taken by mouth.
Abilify is approved to treat depression in adults. It should also be used in combination with other antidepressant medications. It's also approved to treat the following conditions:
Spravato comes as a nasal spray. It's given either once or twice each week. It's usually given in doses of 56 mg or 84 mg.
You'll give Spravato to yourself at a certified healthcare facility. Healthcare providers will monitor you for side effects during and after your treatment. You'll stay at the facility for at least two hours after you receive your dose. Your doctor will let you know when it's safe for you to go home.
Abilify comes in these forms:
There is also an Abilify oral tablet available that has a sensor inside. This sensor can track when you take your medication.
Abilify is usually taken once per day by mouth when used to treat depression. The usual dosage range in adults is 2 mg to 15 mg. This drug can be taken at home. It doesn't need to be given at a certified healthcare facility.
Spravato and Abilify contain very different drugs. Therefore, these medications can cause different side effects. Below are examples of these side effects.
More common side effects
These lists contain examples of more common side effects that can occur with Spravato, with Abilify, or with both drugs (when taken individually).
Serious side effects
These lists contain examples of serious side effects that can occur with Spravato, with Abilify, or with both drugs (when taken individually).
Spravato and Abilify have different FDA-approved uses, but they're both used to treat types of depression. They're given in combination with other antidepressant medications.
The use of Spravato and Abilify haven't been directly compared in clinical studies. Studies have found that both Spravato and Abilify are effective for treating certain types of depression.
Spravato and Abilify are both brand-name drugs. There aren't any generic forms of Spravato available. Abilify tablets and solutions are available in generic forms. Brand-name drugs usually cost more than generics.
According to estimates on GoodRx.com, Spravato may cost more than brand-name and generic forms of Abilify. The actual price you would pay for either drug depends on your dose, your insurance plan, your location, and the pharmacy you use.
Spravato contains the drug esketamine. Symbyax contains two drugs: olanzapine and fluoxetine. These medications belong to different drug classes, but they're both used to treat depression.
Both Spravato and Symbyax are FDA-approved to treat a form of depression called treatment-resistant depression (TRD). Spravato is approved for use in adults, in combination with at least one other antidepressant drug. Symbyax is approved for use alone in adults with TRD.
Symbyax is also approved for acute depressive episodes caused by bipolar I disorder in adults and in children ages 10 years and older.
Spravato comes as a nasal spray. It's given either once or twice each week. It's usually given in doses of 56 mg or 84 mg.
Spravato is self-administered in a certified healthcare facility. Healthcare providers will monitor you for side effects during and after your treatment. You'll stay at the facility for at least two hours after your dose. Your doctor will advise when it's safe for you to go home.
Symbyax comes as a capsule that's taken by mouth. It's taken once daily, in the evening. This drug doesn't need to be taken at a certified healthcare facility.
Symbyax capsules come in several different strengths:
Spravato and Symbyax contain very different medications. Therefore, they can cause different side effects. Below are examples of these side effects.
More common side effects
These lists contain examples of more common side effects that can occur with Spravato, with Symbyax, or with both drugs (when taken individually).
Serious side effects
These lists contain examples of serious side effects that can occur with Spravato, with Symbyax, or with both drugs (when taken individually).
Spravato and Symbyax have different FDA-approved uses, but they're both used to treat treatment-resistant depression (TRD).
These drugs haven't been directly compared to each other in clinical studies. However, both Spravato and Symbyax have been effective to treat depression symptoms during clinical studies.
Spravato and Symbyax are both brand-name drugs. There aren't any generic forms of Spravato available. However, there is a generic form of Symbyax available. Brand-name medications usually cost more than generics.
According to estimates from GoodRx.com, Spravato may cost more than Symbyax. The actual price you would pay for either drug depends on your dose, your insurance plan, your location, and the pharmacy you use.
Spravato shouldn't be taken with alcohol. Both Spravato and alcohol can cause sedation (sleepiness, trouble thinking clearly, inability to drive or use heavy machinery). Taking them together can increase this risk.
Spravato can interact with several other medications. It can also interact with certain supplements as well as certain foods.
Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.
Below are lists of medications that can interact with Spravato. These lists do not contain all the drugs that may interact with Spravato.
Before taking Spravato, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.
If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.
Spravato and opioids can both cause sedation. Taking Spravato together with opioid drugs can cause excessive sedation (sleepiness, trouble thinking clearly, inability to drive or use heavy machinery).
If you're taking an opioid pain medication and need Spravato treatment, talk to your doctor about your risk of sedation. You may need to be monitored for a longer time after taking Spravato to make sure that you don't feel sedated after treatment.
Examples of opioids that can increase the risk of sedation if taken with Spravato include:
Many pain relievers contain a combination of drugs, and one of those drugs may be an opioid. Be sure to tell your doctor about all medications you take. If you're taking an opioid, they may recommend a different medication for you. This can help you avoid an increased risk of sedation.
Spravato and benzodiazepines can both cause sedation. Taking Spravato and benzodiazepines together can cause excessive sedation (sleepiness, trouble thinking clearly, inability to drive or use heavy machinery).
If you're taking a benzodiazepine and considering Spravato treatment, talk with your doctor about the risk of sedation. You may need to be monitored for a longer time after taking Spravato to make sure that you don't feel sedated after treatment.
Examples of benzodiazepines that can increase sedation if taken with Spravato include:
Taking Spravato with medications that are used to help you fall or stay asleep can cause prolonged or worsened sedation (sleepiness, trouble thinking clearly, inability to drive or use heavy machinery).
Talk to your doctor if you take medications to help you sleep. They may recommend that you skip your sleep medication on the night before your Spravato dose.
If you take medications to help you sleep, you may need to be monitored for a longer time after taking Spravato. This will help make sure that you are not sedated after your treatment.
Examples of sleep medication that can increase sedation if taken with Spravato include:
Taking Spravato with stimulant medications may increase blood pressure more than either drug would alone. Increased blood pressure could cause serious complications with blood vessels in your heart or brain. These complications include heart attack, stroke, or swelling in your brain.
Examples of stimulant medications include:
If you are taking a stimulant medication, talk to your doctor about your risk of elevated blood pressure. You may need to be monitored more closely after taking Spravato for dangerously high blood pressure.
Taking Spravato with monoamine oxidase inhibitors (MAOIs) can cause an increase in blood pressure. Increased blood pressure could cause serious complications with blood vessels in your heart or brain. These complications include heart attack, stroke, or swelling in your brain.
MAOIs are a class of medications used to treat depression. Examples of MAOIs that can cause high blood pressure if taken with Spravato include:
If you are taking an MAOI, talk to your doctor about your risk of elevated blood pressure. They may monitor you more closely for dangerously high blood pressure after your Spravato treatments.
Taking a nasal corticosteroid or nasal decongestant around the time of your Spravato dose may reduce how much Spravato your body absorbs. This could make the drug less effective for you.
To avoid this interaction, don't use a nasal corticosteroid or nasal decongestant for at least one hour before your Spravato dose.
Eating or drinking certain things around the time of your Spravato dose may increase your risk of side effects.
Spravato can cause nausea and vomiting in some people. To reduce this risk:
Caffeine, which is a stimulant, can increase your blood pressure. Spravato may also increase blood pressure. Taking Spravato with caffeine could increase your blood pressure to levels that are not safe.
If you consume caffeine, talk with your doctor about how much is safe for you to consume on the day of your Spravato dose.
Spravato is not recommended for use during pregnancy. In animal studies, pregnant females who received Spravato had offspring with brain and bone damage. However, it's not known how Spravato use during pregnancy would affect humans.
If you are pregnant or may become pregnant, talk with your doctor about the safety of Spravato use during pregnancy.
If you take Spravato during pregnancy, you are encouraged to contact the National Pregnancy Registry for Antidepressants. This registry collects information about the safety of antidepressant use during pregnancy. You can register by calling 844-405-6185 or visiting the NPRAD website.
Breastfeeding is not recommended for women who are taking Spravato.
It's not known for sure how Spravato would affect humans who consume it in breast milk. However, it is known that the drug passes into human breast milk. In animal studies, Spravato passed into the breastmilk of lactating mothers and caused brain damage when this milk was consumed by animals.
If you're breastfeeding and considering Spravato treatment, your doctor may recommend that you stop breastfeeding while you receive treatment.
Here are answers to some frequently asked questions about Spravato.
Spravato is considered controversial by some people for two main reasons:
The active drug in Spravato is called esketamine, which is made from ketamine. Ketamine is approved by the Food and Drug Administration (FDA) for use as an anesthetic. However, it's also taken as a 'party drug' that's referred to as 'Special K' and can be misused.
It's important to note that Spravato and ketamine are not the same drug (see the next section, 'What's the difference between esketamine and ketamine?'). Both drugs are only available with a prescription from a healthcare provider. However, Spravato is only given at certified healthcare facilities and can't be purchased for use at home.
As for the second concern about Spravato, it can cause serious side effects, including sedation (sleepiness, trouble thinking clearly, or inability to drive or use heavy machinery) and dissociation (an 'out-of-body' experience). Because Spravato has these serious side effects, the FDA has placed restrictions on its use. It can only be given through a Risk Evaluation and Mitigation Strategy (REMS) (see the section below, 'What is a REMS?') at certified medical facilities.
The REMS requires that after taking Spravato, you'll be monitored by a healthcare provider for at least two hours. During this time, they'll watch you for side effects. They'll also make sure it's safe for you to leave the facility.
You shouldn't drive at all on the day of your Spravato treatment. You'll need to have someone who can drive you home after your treatment. You'll be able to resume driving the day following your treatment.
Esketamine (the active drug in Spravato) and ketamine are not the same drug, but they are similar chemicals. Esketamine is found in ketamine. It's what's called an enantiomer.
Ketamine contains a mixture of enantiomers, which are two chemicals that are mirror images of each other. Enantiomers look similar to each other but have different effects inside the body. Esketamine is one of these mirror images found within ketamine. Esketamine is made when it's removed from ketamine.
It's thought that ketamine and esketamine work differently because of their different structures. These drugs interact in different ways with nerves in your brain.
Spravato is approved to treat a form of depression called treatment-resistant depression (TRD). It's used in combination with other antidepressant medications taken by mouth.
Ketamine isn't approved to treat depression at this time. However, it is approved for use as an anesthetic drug during surgeries or other medical procedures.
Several small studies have looked at using ketamine to treat depression. These studies have had promising short-term results. Up to 71% of people who took ketamine had improved depression symptoms. However, more studies are needed to know if ketamine is safe and effective for long-term treatment of depression.
A REMS (Risk Evaluation and Mitigation Strategy) is a program created by the Food and Drug Administration (FDA). It's used to reduce the risks related to prescribing certain drugs.
The FDA requires that some prescription drugs be given through REMS programs. This typically includes drugs that have serious side effects.
REMS programs help educate consumers on how to safely use certain medications. REMS programs also teach healthcare providers how to prescribe certain drugs. This helps doctors know if the drug's benefit outweighs its risk when used for medical treatment.
The REMS program for Spravato requires that healthcare facilities that give Spravato be certified to administer the drug. Spravato isn't available for purchase at your local pharmacy. You can only receive the drug at certified healthcare facilities.
The REMS program also requires that you're fully informed of the risks before taking Spravato. Risks can include serious side effects such as sedation (sleepiness, trouble thinking clearly, or inability to drive or use heavy machinery) and dissociation (an 'out-of-body' experience).
If you're taking Spravato, you'll need to sign an enrollment form stating that you understand the following:
Additional information about the REMS requirements for Spravato can be found on the FDA's website.
No, it's not. The active drug in Spravato (esketamine) isn't approved for use as an anesthetic for surgery. Ketamine (a drug similar to esketamine) is FDA-approved to be used as an anesthetic.
Yes, Spravato can cause hallucinations in some people. This side effect is most likely to occur within minutes to hours after taking Spravato.
You'll stay at your doctor's office for at least two hours after you take Spravato. This allows the healthcare provider to monitor you for any side effects, including hallucinations. Your healthcare provider will let you know when they feel you can safely go home.
This drug comes with several warnings.
This drug has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.
Before taking Spravato, talk with your doctor about your health history. Spravato may not be right for you if you have certain medical conditions. These include:
Note: For more information about the potential negative effects of Spravato, see the 'Spravato side effects' section above.
The following information is provided for clinicians and other healthcare professionals.
Spravato (esketamine) is FDA-approved to treat treatment-resistant depression in combination with oral antidepressant therapy. It is only approved for use in adults.
Spravato is the S-enantiomer of ketamine. It is a nonselective, noncompetitive antagonist of the NMDA receptor. It works by blocking glutamate activity. The exact mechanism of action for treating depression is unknown.
Esketamine exposure is dose-proportional between 56 mg and 84 mg. There is no evidence of accumulation from twice weekly dosing.
Absolute bioavailability is approximately 48% following nasal administration. Maximum concentration is reached within 20 to 40 minutes after the dose. Decline in concentration is biphasic; levels rapidly decline in the first 2 to 4 hours, but have a terminal half-life of 7 to 12 hours.
Protein binding is 43% to 45%. Metabolism occurs via CYP2B6, CYP3A4, CYP2C9, and CYP2C19. Elimination of metabolites occurs primarily in urine, and to a lesser degree in feces.
Spravato is contraindicated in patients with a history of hypersensitivity to esketamine, ketamine, or any of Spravato's excipients.
Spravato is also contraindicated in people with aneurysmal vascular disease, arteriovenous malformation, or history of intracerebral hemorrhage.
Spravato is classified by the DEA as a Schedule III controlled substance, indicating a potential for misuse and dependence.
Spravato should be stored at room temperature (68°F to 77°F/20°C to 25°C). Used devices should be disposed of per applicable schedule three (III) drug laws.
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.