Spravato
SPRAVATO® (esketamine) CIII Nasal Spray
A Breakthrough Treatment for Resistant Depression
SPRAVATO® is the first FDA-approved nasal spray for adults with treatment-resistant depression (TRD) or suicidal thoughts in MDD. Administered under medical supervision for rapid relief.
What is SPRAVATO?
SPRAVATO® is a prescription nasal spray used:
- With an oral antidepressant for treatment-resistant depression (TRD) in adults.
- For depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts/actions.
Limitations of Use:
- Not for use as an anesthetic.
- Not proven to prevent suicide or reduce suicidal ideation.
- Not for use in children.
Clinical Administration
Administered only in certified healthcare settings under direct observation (SPRAVATO-pi.pdf, Page 2, “SPRAVATO REMS Program”).
Patients must be monitored for ≥2 hours post-dose for sedation, dissociation, and respiratory depression (SPRAVATO-pi.pdf, Boxed Warning).
Dosing Protocol
Nasal spray device delivers 28 mg per device (2 sprays total).
Dose options:
56 mg = 2 devices
84 mg = 3 devices
Dosage Schedule
| Phase | Frequency | Duration | Key Considerations |
|---|---|---|---|
| Induction | Twice weekly | Weeks 1-4 | Evaluate therapeutic benefit after 4 weeks (SPRAVATO-pi.pdf, Page 2, “Dosage and Administration”). |
| Maintenance | Weekly → Biweekly | Week 5+ | Individualized to “least frequent dosing to maintain remission” (SPRAVATO-pi.pdf, Page 2, Table 1). |
How SPRAVATO® Works
SPRAVATO® (esketamine) is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist that:
Important Safety Information
Sedation, Dissociation, and Respiratory Depression:
1: SPRAVATO® may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).
2: Breathing problems (respiratory depression and respiratory arrest) were observed.
3: Your healthcare provider must monitor you for at least 2 hours after administration.
Abuse and Misuse:
1: SPRAVATO® is a Schedule III controlled substance. There is a risk for abuse and misuse which may lead to physical or psychological dependence.
2: Your healthcare provider should check you for signs of abuse before and during treatment.
Suicidal Thoughts and Behaviors:
1: Antidepressants may increase suicidal thoughts/actions in patients ≤24 years, especially during initial treatment or dose changes.
2: Monitor all patients for worsening depression or emergent suicidal behaviors.
Serious side effects requiring immediate medical attention:
Blood pressure increases: May cause temporary spikes (monitored for ≥2 hours post-dose)
Suicidal thoughts/behaviors: Especially in patients ≤24 years
Respiratory depression: Rare cases of breathing problems/respiratory arrest
Cognitive impairment: Trouble thinking clearly
Bladder issues: Urinary frequency/pain
These typically occur right after dosing and resolve the same day.
Patient Resources
Because of risks of sedation, dissociation, respiratory depression, abuse and misuse, SPRAVATO is only available through a restricted program called the SPRAVATO REMS. SPRAVATO can only be administered at healthcare settings certified in the SPRAVATO REMS Program.
Pregnancy Exposure Registry
There is a pregnancy registry that monitors outcomes in women exposed to SPRAVATO during pregnancy. Healthcare providers can register patients by contacting:
Full Prescribing Information
Includes Boxed WARNINGS, Medication Guide, and complete safety data.
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