France has become the first country in the world to officially authorize the use of intravenous ketamine in the treatment of adults experiencing a severe suicidal crisis. Mental health experts consider the decision historic and see it as a significant step forward in suicide risk management.
The approval, announced in March 2026 by the French drug regulatory agency —the L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)—represents a significant advance in the clinical response to the imminent risk of suicide. Until now, there had been no formally approved fast-acting pharmacological alternative for these urgent cases.
Intravenous ketamine: What are the effects?
Over the past decade, several clinical trials and meta-analyses have shown that one or two administrations of low-dose ketamine (10 mg/mL) can reduce suicidal ideation within a few hours. The benefits last for several days or weeks. This rapid effect clearly distinguishes ketamine from conventional antidepressants, which generally take weeks to produce significant clinical results.
How does it differ from nasal esketamine?
Currently, esketamine administered nasally —esketamine being a variant of the ketamine molecule—is already approved in several countries for the treatment of treatment-resistant depression. However, the available studies have not confirmed a significant effect in reducing suicidal ideation.
The Lancet also points out another argument in favor of using generic racemic ketamine—now approved in France—in these cases: the fact that it costs significantly less than nasal esketamine. Structured follow-up could facilitate broader access.
How is this use regulated in France?
The French authorization was granted under a compassionate use program, and the ANSM will reassess the authorization in three years. The psychiatrist may only administer the treatment in a hospital setting, based on a prescription from a psychiatrist and as part of a broader treatment plan. The measure applies to adult patients experiencing a severe suicidal crisis, regardless of any other associated psychiatric diagnoses.
Experts warn, however, that ketamine is not a permanent cure. The anti-suicidal effect tends to be temporary; about 10% of patients show no improvement, and half may have variable responses over the course of six weeks, according to a large-scale study. Questions also remain regarding the risks of prolonged use or misuse, which is why the authors advocate for rigorous pharmacovigilance systems and national clinical registries.
This is a supplement, not a replacement
According to *The Lancet*, the researchers emphasize that this approach should not divert resources from proven suicide prevention strategies, such as continuity of care, psychological support, and access to psychotherapy. Nevertheless, they believe that this approval fills a critical gap. Between the recognition of an acute suicidal crisis and an intervention capable of altering its course, there was no approved rapid pharmacological alternative.
In addition, one of the most significant aspects of the French decision is that intravenous ketamine is not presented as a stand-alone treatment, but rather as part of a multimodal treatment pathway that includes, in particular, psychotherapy. In practice, this means that the hospital administration of this substance must be accompanied by a specialized psychiatric evaluation and clinical monitoring. Structured follow-up after the acute phase is also mandatory.
The goal is to use ketamine’s rapid effect in reducing suicidal ideation as an emergency intervention, in conjunction with ongoing care, therapeutic adjustments, and, if necessary, psychotherapy. International experts have emphasized that this combination can be crucial for consolidating clinical improvements and addressing underlying psychological factors, such as trauma, hopelessness, or the risk of relapse.
Learn about The Clinic of Change’s ketamine-assisted therapy protocols HERE.
