REMS restricted

Esketamine

SPRAVATO

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Pronunciation: es-KET-a-meen (spra-VAH-toe)

Esketamine ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Esketamine ballicule

Esketamine SPRAVATO mascot mnemonic cartoon — Visual mnemonic: Esketamine mascot
**“Spray gato”**

What it isNMDA receptor antagonist given intranasally; treatment-resistant depression.

Why this oneAntidepressant benefit can begin within hours rather than weeks, including in depression with acute suicidal ideation.

What limits itSedation and dissociation require two hours of monitoring in a REMS-certified setting. Abuse potential; blood pressure rises acutely.

Esketamine molecular structure (skeletal formula) — Molecular structure: Esketamine

FDA-approved for

treatment-resistant depression (2019)
depression with acute suicidality (2020)

FDA label

Read the full label on DailyMed ↗

BOXED WARNING Sedation; dissociation; respiratory depression; abuse and misuse; suicidal thoughts and behaviors — available only through a restricted REMS program with post-dose monitoring.

FDA dosing	Population	Start	Target	Max
Treatment-resistant depression (monotherapy or with oral AD)	Adults	56 mg twice weekly (induction wk 1-4)	56-84 mg weekly (wk 5-8), then q2wk or weekly	84 mg
Depressive symptoms in MDD with acute suicidal ideation/behavior (with oral AD)	Adults	84 mg twice weekly x4 wk (may reduce to 56 mg BIW)	84 mg twice weekly	84 mg

Renal Undefined

Hepatic Undefined

Device delivers 28 mg; use 2 devices (56 mg) or 3 devices (84 mg) with 5-minute rest between devices

Instructions

Intranasal use only under direct healthcare-provider supervision
Assess BP before and ~40 min after dosing; observe patient at least 2 hours
Avoid food 2 h before and liquids 30 min before administration
Nasal corticosteroid/decongestant at least 1 h before
Do not drive/operate machinery until next day after restful sleep

Available strengths

nasal spray 28 mg
sol 28 mg/.2 mL

Contraindications

Aneurysmal vascular disease (thoracic/abdominal aorta, intracranial, peripheral) or arteriovenous malformation
History of intracerebral hemorrhage

Cautions

MAOIs due to risk of serotonin syndrome
Sedation/loss of consciousness
Dissociation and perceptual changes
Respiratory depression
Increases in blood pressure
Cognitive impairment
Impaired ability to drive/operate machinery
Ulcerative or interstitial cystitis
Abuse and misuse
Embryo-fetal toxicity

Adverse reactions

Dissociation
Dizziness
Nausea
Sedation
Vertigo
Hypoesthesia
Anxiety
Lethargy
Blood pressure increased
Vomiting
Feeling drunk
Headache

Pregnancy Not recommended in pregnancy; may cause fetal harm

Lactation Present in human milk; breastfeeding not recommended

Cost

Esketamine (SPRAVATO)

Strength		#/mo	generic $/unit	CostPlus
28 mg	nasal spray	per unit		not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Esketamine is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2030s est.

⚠ BOXED WARNINGS

Sedation
Dissociation
Abuse and misuse
Suicidal thoughts and behaviors

Classes and tags

Clinical profile

Therapeutic safety burden4 / 4

Overdose danger3 / 4

Weight-gain liability1 / 4

Sedation liability3 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk2 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityDissociation, sedation and blood-pressure elevation require supervised dosing and observation.

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Memory aids: interaction avatars

CYP2B6 substrate

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