Spravato Side Effects Center

Last updated on RxList: 4/28/2022
Spravato Side Effects Center

What Is Spravato?

Spravato (esketamine) Nasal Spray is a non-competitive N-methyl D-aspartate (NMDA) receptor antagonist indicated, in conjunction with an oral antidepressant, for the treatment of treatment-resistant depression (TRD) in adults.

What Are Side Effects of Spravato?

Common side effects of Spravato include:

Dosage for Spravato

The day 1 starting dose of Spravato is 56 mg. Subsequent doses of of Spravato are 56 mg or 84 mg administered twice a week for weeks 1 to 4, once weekly weeks 5 to 8, and every 2 weeks or once weekly week 9 and after.

What Drugs, Substances, or Supplements Interact with Spravato?

Spravato may interact with CNS depressants (e.g., benzodiazepines, opioids, alcohol), psychostimulants (e.g., amphetamines, methylphenidate, modafanil, armodafinil), and monoamine oxidase inhibitors (MAOIs). Tell your doctor all medications and supplements you use.

Spravato During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Spravato; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including Spravato, during pregnancy. Spravato passes into breast milk. Because of the potential for neurotoxicity, breastfeeding is not recommended while using Spravato. Withdrawal symptoms may occur if you suddenly stop taking Spravato.

Additional Information

Our Spravato (esketamine) Nasal Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Depression is a(n) __________ . See Answer
Spravato Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Your blood pressure will need to be checked before and after you use esketamine. Esketamine can increase your blood pressure for several hours after each dose. Tell your doctor if you have chest pain, trouble breathing, severe headache, blurred vision, pounding in your neck or ears, or a seizure.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Also call your doctor at once if you have:

  • extreme drowsiness or feeling like you might pass out;
  • severe dizziness or feelings of floating;
  • problems with thinking or memory;
  • unusual or unpleasant memories (flashbacks);
  • hallucinations, feeling "spaced out"; or
  • urination problems (painful urination, increased urination, urgent need to urinate).

Common side effects may include:

  • dissociation, feeling drunk;
  • increased blood pressure;
  • drowsiness, lack of energy;
  • dizziness, spinning sensation;
  • feeling anxious;
  • nausea, vomiting; or
  • decreased sensations (touch or other senses).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Learn to Spot Depression: Symptoms, Warning Signs, Medication See Slideshow
Spravato Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Sedation [see WARNINGS AND PRECAUTIONS]
  • Dissociation [see WARNINGS AND PRECAUTIONS]
  • Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Cognitive Impairment [see WARNINGS AND PRECAUTIONS]
  • Impaired Ability to Drive and Operate Machinery [see WARNINGS AND PRECAUTIONS]
  • Ulcerative or Interstitial Cystitis [see WARNINGS AND PRECAUTIONS]
  • Embryo-fetal Toxicity [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Treatment-Resistant Depression

SPRAVATO was evaluated for safety in 1709 adults diagnosed with treatment-resistant depression (TRD) [see Clinical Studies] from five Phase 3 studies (3 short-term and 2 long-term studies) and one Phase 2 dose-ranging study. Of all SPRAVATO-treated patients in the completed Phase 3 studies, 479 (30%) received at least 6 months of treatment, and 178 (11%) received at least 12 months of treatment.

Adverse Reactions Leading to Discontinuation of Treatment

In short-term studies in adults <65 years old (Study 1 pooled with another 4-week study), the proportion of patients who discontinued treatment because of an adverse reaction was 4.6% in patients who received SPRAVATO plus oral AD compared to 1.4% for patients who received placebo nasal spray plus oral AD. For adults ≥65 years old, the proportions were 5.6% and 3.1%, respectively. In Study 2, a long-term maintenance study, the discontinuation rates because of an adverse reaction were similar for patients receiving SPRAVATO plus oral AD and placebo nasal spray plus oral AD in the maintenance phase, at 2.6% and 2.1%, respectively. Across all Phase 3 studies, adverse reactions leading to SPRAVATO discontinuation in more than 2 patients were (in order of frequency): anxiety (1.2%), depression (0.9%), blood pressure increased (0.6%), dizziness (0.6%), suicidal ideation (0.5%), dissociation (0.4%), nausea (0.4%), vomiting (0.4%), headache (0.3%), muscular weakness (0.3%), vertigo (0.2%), hypertension (0.2%), panic attack (0.2%) and sedation (0.2%).

Most Common Adverse Reactions

The most commonly observed adverse reactions in patients treated with SPRAVATO plus oral AD (incidence ≥5% and at least twice that of placebo nasal spray plus oral AD) were dissociation, dizziness, nausea, sedation, vertigo, hypoesthesia, anxiety, lethargy, blood pressure increased, vomiting, and feeling drunk.

Table 3 shows the incidence of adverse reactions that occurred in patients treated with SPRAVATO plus oral AD at any dose and greater than patients treated with placebo nasal spray plus oral AD.

Table 3: Adverse Reactions Occurring in ≥2% of Adult TRD Patients Treated with SPRAVATO + Oral AD at Any Dose and at a Greater Rate than Patients Treated with Placebo Nasal Spray + Oral AD

SPRAVATO + Oral AD
(N=346)
Placebo + Oral AD
(N=222)
Cardiac disorders
  Tachycardia* 6 (2%) 1 (0.5%)
Ear and labyrinth disorders
  Vertigo* 78 (23%) 6 (3%)
Gastrointestinal disorders
  Nausea 98 (28%) 19 (9%)
  Vomiting 32 (9%) 4 (2%)
  Diarrhea 23 (7%) 13 (6%)
  Dry mouth 19 (5%) 7 (3%)
  Constipation 11 (3%) 3 (1%)
General disorders and administration site conditions
  Feeling drunk 19 (5%) 1 (0.5%)
  Feeling abnormal 12 (3%) 0 (0%)
Investigations
  Blood pressure increased* 36 (10%) 6 (3%)
Nervous system disorders
  Dizziness* 101 (29%) 17 (8%)
  Sedation* 79 (23%) 21 (9%)
  Headache* 70 (20%) 38 (17%)
  Dysgeusia* 66 (19%) 30 (14%)
  Hypoesthesia* 63 (18%) 5 (2%)
  Lethargy* 37 (11%) 12 (5%)
  Dysarthria* 15 (4%) 0 (0%)
  Tremor 12 (3%) 2 (1%)
  Mental impairment 11 (3%) 2 (1%)
Psychiatric disorders
  Dissociation* 142 (41%) 21 (9%)
  Anxiety* 45 (13%) 14 (6%)
  Insomnia 29 (8%) 16 (7%)
  Euphoric mood 15 (4%) 2 (1%)
Renal and urinary disorders
  Pollakiuria 11 (3%) 1 (0.5%)
Respiratory, thoracic and mediastinal disorders
  Nasal discomfort* 23 (7%) 11 (5%)
  Throat irritation 23 (7%) 9 (4%)
  Oropharyngeal pain 9 (3%) 5 (2%)
Skin and subcutaneous tissue disorders
  Hyperhidrosis 14 (4%) 5 (2%)
* The following terms were combined:
Anxiety includes: agitation; anticipatory anxiety; anxiety; fear; feeling jittery; irritability; nervousness; panic attack; tension
Blood pressure increased includes: blood pressure diastolic increased; blood pressure increased; blood pressure systolic increased; hypertension
Dissociation includes: delusional perception; depersonalization/derealization disorder; derealization; diplopia; dissociation; dysesthesia; feeling cold; feeling hot; feeling of body temperature change; hallucination; hallucination, auditory; hallucination, visual; hyperacusis; illusion; ocular discomfort; oral dysesthesia; paresthesia; paresthesia oral; pharyngeal paresthesia; photophobia; time perception altered; tinnitus; vision blurred; visual impairment
Dizziness includes: dizziness; dizziness exertional; dizziness postural; procedural dizziness
Dysarthria includes: dysarthria; slow speech; speech disorder
Dysgeusia includes: dysgeusia; hypogeusia
Headache includes: headache; sinus headache
Hypoesthesia includes: hypoesthesia; hypoesthesia oral, hypoesthesia teeth, pharyngeal hypoesthesia
Lethargy includes: fatigue; lethargy
Nasal discomfort includes: nasal crusting; nasal discomfort; nasal dryness; nasal pruritus
Sedation includes: altered state of consciousness; hypersomnia; sedation; somnolence
Tachycardia includes: extrasystoles; heart rate increased; tachycardia
Vertigo includes: vertigo; vertigo positional

Depressive Symptoms In Patients With Major Depressive Disorder With Acute Suicidal Ideation Or Behavior

SPRAVATO was evaluated for safety in 262 adults for the treatment of depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior [see Clinical Studies] from two Phase 3 studies (Study 3 and Study 4) and one Phase 2 study. Of all SPRAVATO-treated patients in the completed Phase 3 studies, 184 (81%) received all eight doses over a 4-week treatment period.

Adverse Reactions Leading to Discontinuation of Treatment

In short-term studies in adults (pooled Study 3 and Study 4), the proportion of patients who discontinued treatment because of an adverse reaction was 6.2% for patients who received SPRAVATO plus oral AD compared to 3.6% for patients who received placebo nasal spray plus oral AD. Adverse reactions leading to SPRAVATO discontinuation in more than 1 patient were (in order of frequency): dissociation-related events (2.6%), blood pressure increased (0.9%), dizziness-related events (0.9%), nausea (0.9%), and sedation-related events (0.9%).

Most Common Adverse Reactions

The most commonly observed adverse reactions in patients treated with SPRAVATO plus oral AD (incidence ≥5% and at least twice that of placebo nasal spray plus oral AD) were dissociation, dizziness, sedation, blood pressure increased, hypoesthesia, vomiting, euphoric mood, and vertigo. Table 4 shows the incidence of adverse reactions that occurred in patients treated with SPRAVATO plus oral AD and greater than patients treated with placebo nasal spray plus oral AD.

Table 4: Adverse Reactions Occurring in ≥2% of Adult Patients with MDD and Acute Suicidal Ideation or Behavior Treated with SPRAVATO + Oral AD and at a Greater Rate than Patients Treated with Placebo Nasal Spray + Oral AD

SPRAVATO + Oral AD
(N=227)
Placebo + Oral AD
(N=225)
Cardiac disorders
  Tachycardia* 8 (4%) 2 (1%)
Ear and labyrinth disorders
  Vertigo 14 (6%) 1 (0.4%)
Gastrointestinal disorders
  Nausea 61 (27%) 31 (14%)
  Vomiting 26 (11%) 12 (5%)
  Constipation 22 (10%) 14 (6%)
  Dry mouth 8 (4%) 6 (3%)
  Toothache 5 (2%) 2 (1%)
General disorders and administration site conditions
  Feeling drunk 8 (4%) 1 (0.4%)
  Feeling of relaxation 5 (2%) 3 (1%)
Investigations
  Blood pressure increased* 34 (15%) 14 (6%)
Musculoskeletal and connective tissue disorders
  Myalgia 5 (2%) 1 (0.4%)
Nervous system disorders
  Dizziness* 103 (45%) 34 (15%)
  Sedation* 66 (29%) 27 (12%)
  Dysgeusia* 46 (20%) 29 (13%)
  Hypoesthesia* 30 (13%) 4 (2%)
  Lethargy* 10 (4%) 4 (2%)
  Confusional state 5 (2%) 0 (0%)
Psychiatric disorders
  Dissociation* 108 (48%) 30 (13%)
  Anxiety* 34 (15%) 20 (9%)
  Euphoric mood 17 (7%) 1 (0.4%)
  Intentional self-injury 7 (3%) 3 (1%)
  Dysphoria 5 (2%) 0 (0%)
Renal and urinary disorders
  Pollakiuria* 5 (2%) 2 (1%)
Respiratory, thoracic and mediastinal disorders
  Oropharyngeal pain 10 (4%) 3 (1%)
  Throat irritation 9 (4%) 5 (2%)
Skin and subcutaneous tissue disorders
  Hyperhidrosis* 11 (5%) 5 (2%)
* The following terms were combined:
Anxiety includes: agitation; anxiety; anxiety disorder; fear; irritability; nervousness; panic attack; psychomotor hyperactivity; tension
Blood pressure increased includes: blood pressure diastolic increased; blood pressure increased; blood pressure systolic increased; hypertension
Dissociation includes: depersonalization/derealization disorder; derealization; diplopia; dissociation; dysesthesia; feeling cold; feeling hot; hallucination; hallucination, auditory; hallucination, visual; hallucinations, mixed; hyperacusis; paresthesia; paresthesia oral; pharyngeal paresthesia; photophobia; time perception altered; tinnitus; vision blurred
Dizziness includes: dizziness; dizziness exertional; dizziness postural
Dysgeusia includes: dysgeusia; hypogeusia
Hyperhidrosis includes: cold sweat; hyperhidrosis
Hypoesthesia includes: hypoesthesia; hypoesthesia oral; intranasal hypoesthesia; pharyngeal hypoesthesia
Lethargy includes: fatigue; lethargy; psychomotor retardation
Pollakiuria includes: micturition urgency; pollakiuria
Sedation includes: sedation; somnolence; stupor
Tachycardia includes: heart rate increased; sinus tachycardia; tachycardia

Sedation

Sedation was evaluated by adverse event reports and the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S). In the MOAA/S, 5 means “responds readily to name spoken in normal tone” and 0 means “no response after painful trapezius squeeze.” Any decrease in MOAA/S from pre-dose is considered to indicate the presence of sedation, and such a decrease occurred in a higher number of patients on SPRAVATO than placebo during the short-term TRD studies. Dose-related increases in the incidence of sedation (MOAA/S score <5) were observed in a fixed-dose TRD study [see WARNINGS AND PRECAUTIONS]. Table 5 presents the incidence of sedation (MOAA/S score <5) in a fixed-dose study with adult patients <65 years of age with TRD and a flexible-dose study with patients ≥65 years of age with TRD.

Table 5: Incidence of Sedation (MOAA/S Score <5) in Double-Blind, Randomized, Placebo-Controlled Studies (Fixed-Dose Study with Adult Patients <65 Years of Age with TRD and Flexible-Dose Study with Patients ≥65 Years of Age with TRD)

Patients <65 years Patients ≥65 years
Placebo + Oral AD SPRAVATO + Oral AD Placebo + Oral AD SPRAVATO + Oral AD
28 to 84 mg
56 mg 84 mg
Number of patients*/td> N=112 N=114 N=114 N=63 N=72
Sedation (MOAA/S score <5) 11% 50% 61% 19% 49%
* Patients who were evaluated with MOAA/S

In studies for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior, there was a higher incidence of sedation (MOAA/S score <5) in patients treated with SPRAVATO plus oral AD compared to patients treated with placebo plus oral AD, similar to the TRD study results in Table 5.

Dissociation/Perceptual Changes

SPRAVATO can cause dissociative symptoms (including derealization and depersonalization) and perceptual changes (including distortion of time and space, and illusions). In clinical trials, dissociation was transient and occurred on the day of dosing. Dissociation was evaluated by adverse event reports and the Clinician-Administered Dissociative States Scale (CADSS). A CADSS total score of more than 4 indicates the presence of dissociative symptoms, and such an increase to a score of 4 or more occurred in a higher number of patients on SPRAVATO compared to placebo during the short-term TRD studies. Dose-related increases in the incidence of dissociative symptoms (CADSS total score >4 and change >0) were observed in a fixed-dose TRD study [see WARNINGS AND PRECAUTIONS]. Table 6 presents the incidence of dissociation (CADSS total score >4 and change >0) in a fixed-dose study with adult patients <65 years of age with TRD and a flexible-dose study with patients ≥65 years of age with TRD.

Table 6: Incidence of Dissociation (CADSS Total Score >4 and Change >0) in Double-Blind, Randomized, Placebo-Controlled Studies (Fixed-Dose Study with Adult Patients <65 Years of Age with TRD and Flexible-Dose Study with Patients ≥65 Years of Age with TRD)

Patients <65 years Patients ≥65 years
Placebo + Oral AD SPRAVATO + Oral AD Placebo + Oral AD SPRAVATO + Oral AD 28 to 84 mg
56 mg 84 mg
Number of patients* N=113 N=113 N=116 N=65 N=72
CADSS total score >4 and change >0 5% 61% 69% 12% 75%
* Number of patients who were evaluated with CADSS

In studies for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior, patients treated with SPRAVATO plus oral AD also demonstrated a higher number (84%) with dissociation (CADSS total score >4 and change >0) compared to patients treated with placebo plus oral AD (16%).

Increase In Blood Pressure

The mean placebo-adjusted increases in systolic and diastolic blood pressure (SBP and DBP) over time were about 7 to 9 mmHg in SBP and 4 to 6 mmHg in DBP at 40 minutes post-dose and 2 to 5 mmHg in SBP and 1 to 3 mmHg in DBP at 1.5 hours post-dose in patients with TRD receiving SPRAVATO plus oral antidepressants [see WARNINGS AND PRECAUTIONS]. Table 7 presents increases in blood pressure in short-term trials with patients <65 years of age and ≥65 years of age with TRD.

Table 7: Increases in Blood Pressure in Double-blind, Randomized, Placebo-Controlled, Short-Term Trials of SPRAVATO + Oral AD Compared to Placebo Nasal Spray + Oral AD in the Treatment of TRD in Adult Patients

Patients <65 years Patients ≥65 years
SPRAVATO + Oral AD
N=346
Placebo + Oral AD
N=222
SPRAVATO + Oral AD
N=72
Placebo + Oral AD
N=65
Systolic blood pressure
  ≥180 mmHg 9 (3%) - 2 (3%) 1 (2%)
  ≥40 mmHg increase 29 (8%) 1 (0.5%) 12 (17%) 1 (2%)
Diastolic blood pressure
  ≥110 mmHg 13 (4%) 1 (0.5%) - -
  ≥25 mmHg increase 46 (13%) 6 (3%) 10 (14%) 2 (3%)

In studies for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior, patients treated with SPRAVATO plus oral antidepressants demonstrated similar mean placebo-adjusted increases in SBP and DBP compared to patient with TRD, as well as similar rates of increases to SBP ≥180 mmHg or ≥40 mmHg increases in SBP, and similar rates of increases to DBP ≥110 mmHg or ≥25 mmHg increases in DBP, compared to the TRD study results in Table 7.

Nausea And Vomiting

SPRAVATO can cause nausea and vomiting. Most of these events occurred on the day of dosing and resolved the same day, with the median duration not exceeding 1 hour in most subjects across dosing sessions. Rates of reported nausea and vomiting decreased over time across dosing sessions from the first week of treatment in the short-term studies, as well as over time with long-term treatment. Table 8 presents the incidence and severity of nausea and vomiting in a short-term study with patients with TRD.

Table 8: Incidence and Severity of Nausea and Vomiting in a Double-blind, Randomized, Placebo-Controlled, Fixed-Dose Study in Adult Patients with TRD

Treatment (+ Oral AD) Nausea Vomiting
N All Severe All Severe
SPRAVATO 56 mg 115 31 (27%) 0 7 (6%) 0
SPRAVATO 84 mg 116 37 (32%) 4 (3%) 14 (12%) 3 (3%)
Placebo Nasal Spray 113 12 (11%) 0 2 (2%) 0

In studies for the treatment of depressive symptoms in adults with MDD with acute suicidal ideation or behavior, patients demonstrated similar incidence and severity of reported nausea and vomiting compared to the TRD study results described above.

Sense Of Smell

Sense of smell was assessed over time; no difference was observed between patients treated with SPRAVATO plus oral AD and those treated with placebo nasal spray plus oral AD during the double-blind maintenance phase of Study 2 [see Clinical Studies].

DRUG INTERACTIONS

Central Nervous System Depressants

Concomitant use with CNS depressants (e.g., benzodiazepines, opioids, alcohol) may increase sedation [see WARNINGS AND PRECAUTIONS]. Closely monitor for sedation with concomitant use of SPRAVATO with CNS depressants.

Psychostimulants

Concomitant use with psychostimulants (e.g., amphetamines, methylphenidate, modafinil, armodafinil) may increase blood pressure [see WARNINGS AND PRECAUTIONS]. Closely monitor blood pressure with concomitant use of SPRAVATO with psychostimulants.

Monoamine Oxidase Inhibitors (MAOIs)

Concomitant use with monoamine oxidase inhibitors (MAOIs) may increase blood pressure [see WARNINGS AND PRECAUTIONS]. Closely monitor blood pressure with concomitant use of SPRAVATO with MAOIs.

Drug Abuse And Dependence

Controlled Substance

SPRAVATO contains esketamine hydrochloride, the (S)-enantiomer of ketamine and a Schedule III controlled substance under the Controlled Substances Act.

Abuse

Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of SPRAVATO. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a healthcare provider or for whom it was not prescribed. Careful consideration is advised prior to use of individuals with a history of substance use disorder, including alcohol.

SPRAVATO may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia, flashback, hallucinations, and feelings of floating, detachment and to be “spaced out”. Monitoring for signs of abuse and misuse is recommended.

Abuse Potential Study

A cross-over, double-blind abuse potential study of SPRAVATO and ketamine was conducted in recreational polydrug users (n=34) who had experience with perception-altering drugs, including ketamine. Ketamine, the racemic mixture of arketamine and esketamine, is a Schedule III controlled substance and has known abuse potential. In this study, the mean “Drug Liking at the Moment” and “Take Drug Again” scores for single doses of intranasal SPRAVATO (84 mg and 112 mg – the maximum recommended dose and 1.3 times the maximum recommended dose, respectively) were similar to these scores in the intravenous ketamine (0.5 mg/kg infused over 40 minutes) control group. However, these scores were greater in the SPRAVATO and ketamine groups compared to the placebo group. The 112 mg dose of intranasal SPRAVATO was associated with significantly higher scores for “Hallucinating,” “Floating,” “Detached,” and “Spaced Out” than the 84 mg dose of intranasal SPRAVATO and the intravenous ketamine dose.

Dependence

Physical dependence has been reported with prolonged use of ketamine. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or significant dosage reduction of a drug. There were no withdrawal symptoms captured up to 4 weeks after cessation of esketamine treatment. Withdrawal symptoms have been reported after the discontinuation of frequently used (more than weekly) large doses of ketamine for long periods of time. Such withdrawal symptoms are likely to occur if esketamine were similarly abused. Reported symptoms of withdrawal associated with daily intake of large doses of ketamine include craving, fatigue, poor appetite, and anxiety. Therefore, monitor SPRAVATO-treated patients for symptoms and signs of physical dependence upon the discontinuation of the drug.

Tolerance has been reported with prolonged use of ketamine. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Similar tolerance would be expected with prolonged use of esketamine.

Read the entire FDA prescribing information for Spravato (Esketamine Nasal Spray)

© Spravato Patient Information is supplied by Cerner Multum, Inc. and Spravato Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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