Spravato
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Spravato
What Is Spravato?
Spravato® is the trade name for esketamine, a non‑competitive NMDA receptor antagonist formulated as a nasal spray. It’s a Schedule III controlled substance and is available only through a restricted program because of risks such as sedation, dissociation, and respiratory depression[1][2].
Approved Indications
- Treatment‑resistant depression (TRD) in adults, either alone or with an oral antidepressant[1].
- Depressive symptoms in adults with major depressive disorder (MDD) who have acute suicidal ideation or behavior, always alongside an oral antidepressant[1].
- Limitations: The label notes that Spravato has not been shown to prevent suicide and is not approved as an anesthetic[1].
Dosing Schedule
The nasal spray device delivers 28 mg per actuation. Dosing is individualized based on response and tolerability:
- TRD: Induction (Weeks 1–4): 56 mg or 84 mg twice weekly; Maintenance (Weeks 5–8): 56 mg or 84 mg once weekly; After Week 8: 56 mg or 84 mg every two weeks or once weekly as needed[1].
- MDD with acute suicidal ideation/behavior: 84 mg twice weekly for four weeks (may be reduced to 56 mg for tolerability), administered with an oral antidepressant[1].
Administration
Spravato is administered intranasally under direct supervision at a certified clinic. Patients use two devices for a 56 mg dose or three devices for an 84 mg dose, with a five‑minute rest between devices[1]. Patients must remain in the clinic for at least two hours post‑dose for monitoring and should not drive or operate machinery until the next day after a restful sleep[1][2].
Common Side Effects
Common adverse reactions (≥5 % and at least double the rate of placebo) include:
- Dissociation, dizziness, vertigo
- Nausea, vomiting, feeling drunk
- Hypoesthesia (numbness), anxiety, lethargy
- Increased blood pressure, headache
- In MDD with acute suicidal ideation/behavior: euphoric mood and sedation are also common[1].
Serious Risks & Precautions
- Sedation and loss of consciousness: about half of patients experience sedation, and a small percentage lose consciousness. Continuous monitoring for at least two hours is required[1][2].
- Dissociation: perceptual changes such as derealization and depersonalization occur in over half of patients[1][2].
- Respiratory depression: rare but serious; pulse‑oximetry monitoring is recommended[1][2].
- Abuse and misuse: esketamine is a Schedule III controlled substance; clinicians must assess and monitor for drug‑seeking behaviour[1].
- Increased blood pressure: transient rises are common; contraindicated in patients at risk of serious hypertensive events[1].
- Cognitive impairment & driving: Spravato can impair attention and reaction time; driving or operating machinery is not advised until the next day after sleep[1][2].
- Other warnings: risk of ulcerative or interstitial cystitis with long‑term use; potential fetal harm (not recommended during pregnancy or breastfeeding) and an increased risk of suicidal thoughts in patients under 25[1].
REMS & Monitoring Requirements
Due to the risks of sedation, dissociation, respiratory depression and abuse/misuse, Spravato is dispensed only through the SPRAVATO REMS program. Certified clinics and pharmacies must enroll patients, supervise dosing and monitor them for at least two hours before discharge[1][2].
When to Seek Help
Patients should immediately seek medical attention for signs of a hypertensive crisis (e.g., chest pain, severe headache, vision changes, or confusion), allergic reactions, or new or worsening thoughts of self‑harm. Ongoing communication with healthcare providers and adherence to monitoring requirements is essential[1].