Spravato: Uses, Side Effects and Dosage

Serious warnings and precautions box

What SPRAVATO is used for:

• SPRAVATO is a nasal spray used to treat adults with major depressive disorder that is moderate to severe in intensity and has not responded to two or more separate courses of treatment in the current episode of depression. Separate courses refers to previous treatment with different antidepressants, each given at adequate doses for an adequate amount of time. SPRAVATO nasal spray is used together with an antidepressant taken by mouth that is either a selective serotonin reuptake inhibitor (SSRI) or a serotonin and norepinephrine reuptake inhibitor (SNRI).

• SPRAVATO is also used in adults to quickly reduce symptoms of depression that needs to be treated right away (a condition requiring urgent psychiatric care). SPRAVATO nasal spray is used together with an antidepressant taken by mouth.

  You should tell your healthcare professional or go to the nearest hospital immediately if you have thoughts of harming or killing yourself.

SPRAVATO is not for use in children or adolescents.

If you are 65 years or older, talk to your healthcare professional before starting SPRAVATO. SPRAVATO may not be an effective treatment for you and you may be more sensitive to experiencing side effects.

How SPRAVATO works:

SPRAVATO contains a medicine called esketamine. Esketamine belongs to a group of medicines that work on N-methyl-D-aspartate (NMDA) receptors. It works by changing the activity of certain natural substances in the brain.

The ingredients in SPRAVATO are:

Medicinal ingredients: Esketamine

Non-medicinal ingredients: citric acid monohydrate, disodium edetate, sodium hydroxide, and water for injection

SPRAVATO comes in the following dosage form:

Solution (single-use nasal spray): 28 mg

Each nasal spray device delivers only 2 sprays for a total dose of 28 mg esketamine (as esketamine hydrochloride)

Do not use SPRAVATO if you:

• are allergic to:

  • esketamine
  • a similar medicine called ketamine
  • any of the other ingredients in SPRAVATO (see The ingredients in SPRAVATO are: above)
• have any condition for which high blood pressure or high pressure within your brain (intracranial pressure) poses a serious risk
• have a weak portion of the blood vessel wall (aneurysmal vascular disease), including in your brain, chest or abdominal aorta, arms and legs
• have an abnormal connection between your veins and arteries (arteriovenous malformation)
• have ever had bleeding in the brain
• had a major heart event (such as heart attack) or stroke within the last 6 weeks

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take SPRAVATO. Talk about any health conditions or problems you may have, including if you:

• have heart problems such as:

  • poor blood flow in the blood vessels of the heart frequently with chest pain (such as angina)
  • high blood pressure that is not under control
  • a history of a heart attack
  • a slow or fast heartbeat causing shortness of breath, palpitations or chest discomfort, feeling light-headed or fainting
  • heart valve disease
  • heart failure
• have ever had a stroke or problems with the blood supply to your brain

• have ever had a problem with substance use, including prescribed or illegal drugs, or alcohol

• have ever had a condition called “psychosis” - where you believe in things that are not true (delusions) or see, feel, or hear things that are not there (hallucinations) or have an irrational fear that someone is trying to harm you (paranoia)
• have a history of mania or bipolar disorder
• have ever had an overactive thyroid (hyperthyroidism)
• have urinary tract and bladder problems

• have ever had lung or breathing problems such as:

  • a condition where your heart valve does not pump enough blood out to the lungs (called pulmonary insufficiency)
  • a condition where your breathing stops and starts while you sleep (called sleep apnea)
• have ever had a serious head injury or serious problems affecting the brain, particularly where there is increased pressure in the brain
• have ever had a seizure
• have liver problems
• take any medication, including all prescription, over the counter or natural health products

Other warnings you should know about:

Patients of East Asian Ancestry: Tell your healthcare professional if you are of East Asian (including Japanese or Chinese) ancestry before using SPRAVATO. SPRAVATO may not be an effective treatment for you and you may be more sensitive to experiencing side effects. Your healthcare professional will determine if SPRAVATO is an appropriate treatment for you.

Driving and Machines: SPRAVATO can significantly impair your ability to drive and use machines.

You must:

• wait until the next day, after you have had a restful sleep, before driving or operating machinery or doing tasks that require you to be completely alert
• arrange a safe way to get home after your treatment

Urinary or Bladder Problems: Tell your healthcare professional if you feel pain when urinating or see blood in your urine. These could be signs of urinary or bladder problems. Urinary or bladder problems have been seen in patients using high doses of a similar medicine called ketamine, over a long period of time.

Difficulty Thinking Clearly: Tell your healthcare professional if you have difficulty thinking or remembering. People aged 65 and older may have a slower reaction time after taking SPRAVATO for a long time.

Laboratory Tests: Your healthcare professional may ask you to take a blood test while you are taking SPRAVATO to check your liver function.

Pregnancy: SPRAVATO use during pregnancy may harm your unborn baby.

You should not take SPRAVATO if you:

• are pregnant or plan to become pregnant.
• are a woman of childbearing potential unless you use highly effective contraception (birth control) during and up to 6 weeks after taking your last dose.

Talk to your healthcare professional about methods to prevent pregnancy during treatment with SPRAVATO and tell your healthcare professional right away if you become pregnant during treatment.

There is a pregnancy registry for women who are exposed to antidepressants, including SPRAVATO, during pregnancy. The purpose of the registry is to collect information about the health of pregnant women and their baby. If you become pregnant during treatment with SPRAVATO, talk to your healthcare professional about registering with the National Pregnancy Registry for Antidepressants. Information on the registry can also be found by:

• calling: 1-844-405-6185 or
• online at https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/

Breast-feeding: Do NOT use SPRAVATO if you are breast-feeding. Talk to your healthcare professional before using SPRAVATO if you are breast-feeding. Your healthcare professional will decide if you stop breast-feeding or stop using this medicine. Your healthcare professional will take into account the benefit of breast-feeding for your child, and the benefit of treatment for you.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with SPRAVATO:

• Nasal Sprays (such as oxymetazoline hydrochloride, mometasone furoate): do NOT use a steroid or decongestant nasal spray within 1 hour before your treatment with SPRAVATO.
• Central Nervous System Depressants (such as benzodiazepines, opioids, alcohol): they may make you feel more sleepy if taken together with SPRAVATO.

• Medicines that can cause a severe increase in blood pressure when taken together with SPRAVATO such as:

  • Psychostimulants (such as amphetamines, methylphenidate, modafinil, armodafinil)
  • Monoamine Oxidase Inhibitors (MAOIs) (such as selegiline, phenelzine)
  • Sympathomimetics, triptans and vascular endothelial growth factor receptor inhibitors (such as pazopanib, sunitinib, sorafenib), and some weight loss medications
• Caffeine. You should limit the amount of caffeine you consume when taking SPRAVATO.
• Cannabis (marijuana). Its use should be avoided while taking SPRAVATO.
• Certain herbal remedies or dietary supplements that affect your central nervous system. They should be avoided 24 hours before and after taking SPRAVATO.

Ask your healthcare professional if you are not sure whether the medicines you are taking may interact with SPRAVATO.

How to take SPRAVATO:

You will use the SPRAVATO nasal spray yourself – under the supervision of a healthcare professional in their office or clinic. SPRAVATO is never to be taken home or used without a healthcare professional present.

It can only be given to you by healthcare professionals with experience in treating depression who are enrolled in the JANSSEN JOURNEY™ program. Patients must also be enrolled in the program by a healthcare professional before taking SPRAVATO.

Your healthcare professional will go through a checklist to verify medical information before and after your treatment.

Before you go for your treatment:

• Some patients may experience nausea or vomiting while taking SPRAVATO. You should avoid eating 2 hours before and drinking liquids 30 minutes before taking your dose.
• If you are taking a steroid or decongestant nasal spray, do NOT use it within 1 hour before your treatment.
• Do NOT drink alcohol within 24 hours of your treatment session and 24 hours after each treatment session.
• SPRAVATO can make you feel disconnected or sleepy. Since you cannot drive, you must make arrangements to get home safely after your appointment.

Before taking your dose:

• Your healthcare professional will show you how to use the nasal spray device. Follow their instructions exactly. You should also read the Instructions for Use. It can be found in the package carton.

Usual dose:

Each nasal spray device delivers 2 sprays (one in each nostril) for a total of 28 mg. Your healthcare professional will decide if you need to use 1 (28 mg), 2 (56 mg) or 3 (84 mg) nasal spray devices and how often you should come to their office or clinic to take the medicine.

Adults with major depressive disorder who have not responded to two or more separate courses of treatment:

• Weeks 1-4: your dose should be taken twice per week.
• Weeks 5-8: your dose is taken once per week.
• Week 9 and onwards: your healthcare professional will decide if your dose should be taken once per week or once every 2 weeks.

Quick reduction of symptoms of depression in adults that needs to be treated right away (a condition requiring urgent psychiatric care):

• Weeks 1-4: your dose should be taken twice per week.
• After Week 4, your healthcare professional will decide on the next steps for your course of treatment.

After you have taken your dose:

• Your healthcare professional will confirm that you have taken your full dose.

  • two green dots on the device tells you that the nasal spray is full,
  • one green dot tells you that one spray was used, and
  • no green dots indicates that the full dose of 2 sprays was used.
• You will be monitored for at least 2 hours for possible side effects.
• Your healthcare professional will also monitor your blood pressure and will decide when you can leave their office or clinic.
• It is best to recover in a neutral environment (i.e., few distractions). Try to limit your movement.

Overdose:

This medicine will be given to you under the supervision of your healthcare professional in their office or clinic. Taking too much SPRAVATO may make you more likely to experience side effects such as:

• feeling dizzy
• excessive sweating
• feeling sleepy
• feeling abnormal
• numbness
• nausea and vomiting

Missed dose:

Contact your healthcare professional right away if you miss your treatment session. Your healthcare professional may change your dose or how often you should take SPRAVATO.

Possible side effects from using SPRAVATO:

These are not all the possible side effects you may have when taking SPRAVATO. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of SPRAVATO may include:

• change in sense of taste
• constipation
• decreased feeling or sensitivity, including around the mouth area
• feeling tired, sluggish or have low energy
• feeling very sleepy
• headache
• nausea or vomiting
• abdominal pain or discomfort
• crying
• cough
• diarrhea
• difficulty passing urine
• trouble sleeping
• difficulty speaking
• dry mouth
• excessive sweating
• feeling drunk or abnormal
• feeling extremely happy (“euphoria”)
• increased appetite
• itchy skin
• low sex drive
• migraine
• muscle tremors or spasms
• nose bleed
• nose or throat discomfort
• tunnel vision
• weight gain
• abnormal dreams
• confusion or disorientation
• ear discomfort
• uncontrollable eye movement
• feeling hot
• feeling of relaxation
• feeling uneasy or tense
• feeling weak
• hearing loss
• increased saliva
• mood swings
• muscle stiffness or pain
• nasal congestion
• restlessness
• sneezing
• toothache
• low blood pressure

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

Storage:

SPRAVATO is only available through a controlled distribution program. It will be stored by your healthcare professional. SPRAVATO is never to be given to you to take home.

Do not use the nasal spray after the expiry date which is on package carton and device.

If you want more information about SPRAVATO:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (innovativemedicine.jnj.com/canada) or by calling 1-800-567-3331 or 1-800-387-8781.

Janssen Inc., a Johnson & Johnson company

Toronto, Ontario M3C 1L9

Date of Authorization: 2025-05-23

All trademarks used under license.