Esketamine
SPRAVATO
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.
FDA-approved for
- treatment-resistant depression (2019)
- depression with acute suicidality (2020)
FDA label
Read the full label on DailyMed ↗
| 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
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
⚠ BOXED WARNINGS
- Sedation
- Dissociation
- Abuse and misuse
- Suicidal thoughts and behaviors
Cost, est. cash$300–$2,500/month
Generic entry2030s est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityDissociation, sedation and blood-pressure elevation require supervised dosing and observation.
Mechanism of action: Esketamine ballicule
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