Spravato long-term safety

Spravato long-term: what years of data show.

Spravato has now been studied in people taking it for up to six and a half years. In that long-term study, SUSTAIN-3, no new safety concerns appeared, memory and thinking held steady, and 97% of the side effects that showed up on a treatment day were gone the same day.

An older woman with gray hair in a cream turtleneck smiling warmly in a bright hallway.
The long-term study

What are the long-term side effects of Spravato?

The long-term side effects of Spravato look like its short-term ones: temporary effects on treatment days that clear the same day. In SUSTAIN-3, 1,021 adults with treatment-resistant depression took Spravato with an oral antidepressant for a median of almost four years, and up to six and a half (Zajecka et al., Psych Congress 2023).

What was measuredWhat SUSTAIN-3 found
Side effects on treatment days97.1% resolved the same day. For dissociation, 99.9%; sedation, 99.5%.
Memory and thinkingNo evidence of negative effects on cognition on formal testing over the years of treatment.
BladderNo cases of treatment-related interstitial or ulcerative cystitis.
Blood pressureRises on treatment days settled the same day in 96.4% of cases.
New safety concernsNone identified over up to 6.5 years.

SUSTAIN-3 long-term subgroup analysis (Zajecka J, et al., Psych Congress 2023), an open-label study without a comparison group. See also the SPRAVATO® Prescribing Information.

Memory

Does long-term Spravato affect memory?

Long-term Spravato hasn't been shown to affect memory. Thinking can feel slower for an hour or so after a dose, and it's back to normal by about two hours. Over the long term, in one-year, three-year and six-and-a-half-year studies, memory and thinking stayed stable on formal testing (Spravato Prescribing Information; SUSTAIN-3). That's a real contrast with ECT, where memory loss is a known risk and for some people part of it is lasting.

Bladder

Does Spravato damage the bladder?

Spravato hasn't been shown to damage the bladder. Bladder inflammation has been reported with long-term ketamine misuse, but no cases related to esketamine were seen in the studies, including SUSTAIN-3. More frequent urination can happen, and we ask about it at your visits.

Temporary on purpose

Why Spravato's side effects don't increase over time.

Spravato's side effects are temporary: they stay inside the two hours you rest with us and almost always clear the same day. A daily antidepressant can bring side effects like weight gain, sexual side effects or emotional flatness that persist for as long as you take it. With Spravato, the benefit builds over time while the side effects don't.

What we don't know yet

Six and a half years is the longest data so far.

SUSTAIN-3 was open-label, without a comparison group, and fewer people were still in it at the latest time points. We keep watching how each person does at every visit, for as long as they're with us.

What we monitor

How do we keep long-term treatment safe?

We keep long-term treatment safe by checking the same things at every visit, year after year: your blood pressure before and after the dose, how you're feeling, any new symptoms, bladder changes and your other medicines. After more than 30,000 treatments, that routine is second nature to our team.

A daily antidepressant, month 1

30 doses

Every day.

Side effectsEvery single day: sedation, dry mouth, sexual side effects, weight gain.

Spravato, month 1

8 visits

Twice a week.

Side effectsMostly gone by the end of each visit.

Thinking long-term?

Ask us what years on Spravato look like.

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Long-term questions

What people ask about taking Spravato long-term.

Is it safe to take Spravato long-term?

In SUSTAIN-3, people took Spravato for up to six and a half years with no new safety concerns identified, no evidence of harm to memory, and almost all side effects clearing the same day.

Does Spravato cause brain damage?

No evidence shows that. Memory and thinking stayed stable over years of treatment on formal testing.

Can you take Spravato forever?

There's no fixed end date. Many people stay on maintenance because it keeps them well. How long people stay on Spravato.

Does Spravato stop working over time?

For many people it keeps working in maintenance. If it seems to fade, there are things we can adjust. What if Spravato stops working.