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.

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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.
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Clinical Administration

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.

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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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