What We’re Learning About Long-Term Safety With Spravato®: What You Need to Know

One treatment many patients find life-changing is Spravato®
(esketamine) nasal spray, a medication that works differently from traditional
antidepressants and can rapidly reduce depressive symptoms for patients who haven’t responded to other therapies.

Recently, long-term safety data — extending out to over six years in some studies —
have been published, giving both clinicians and patients important reassurance about its use over time.

Why Long-Term Data Matters

When Spravato® first came to market, most research focused on short-term safety and efficacy — usually up to a year. That’s typical for new psychiatric medications. But because some patients continue Spravato® for years (either in maintenance or
individualized schedules), understanding long-term safety is essential.

Real-World and Clinical Data: What They Show

1. Studies With Years of Follow-Up

The SUSTAIN-3 clinical study has been one of the most informative long-term
investigations of Spravato®. It followed hundreds of adults with treatment-resistant
depression for up to 6.5 years of intermittent, supervised dosing.

• No new safety concerns emerged compared with earlier studies — meaning the types of side effects patients and clinicians already know about remain the main ones seen in long-term use. J&J Medical Connect+1
• Most side effects were mild or transient, occurring around dosing and resolving the same day. OUP Academic
• Few people discontinued because of side effects. OUP Academic

This long-term safety profile has been consistent with both the SUSTAIN-3 data and real-world experience from post-marketing monitoring (hundreds of thousands of treatment sessions), which has not revealed unexpected health risks with proper medical supervision.

What About Rare or Serious Risks?

Long-term data has not shown new safety signals such as unexpected effects on:

• Blood pressure control over time
• Cognitive function long after dosing
• Significant bladder or renal issues when used as directed
• Increased risk of misuse

That said, Spravato® does carry known risks, which is why the FDA requires patients to be treated in an approved setting and observed after each dose. This risk-management approach helps ensure timely identification and mitigation of any adverse effects.

What This Means for You

For many patients with TRD or depressive symptoms with suicidal ideation —
conditions that are often chronic and significantly impair quality of life — the availability of a well-studied, long-term treatment option like Spravato® is meaningful.

Here’s how to interpret the data:

• Long-term use continues to show a favorable safety profile if treatment is
  administered appropriately.
• Side effects that might be uncomfortable are generally predictable and transient.
• Serious long-term harms have not emerged in controlled or real-world data.
• Continued monitoring — both clinical and research-based — remains key to
  optimizing care.

Learn more about what you can expect with ketamine therapy by scheduling a
consultation Book your appointment through our online portal or call our friendly office staff to check availability at 380-214-1636.