Diazepam nasal spray could be effective and safe as a treatment option for patients with Lennox-Gastaut syndrome (LGS) and other neurologic disorders, according to a study recently published in the Journal of Child Neurology.

“These data support the use of diazepam nasal spray in a broad range of pediatric populations (aged ≥6 years), including patients with severe disease,” the authors wrote. 

This post hoc subanalysis of a phase 3 clinical trial evaluated the use of diazepam nasal spray in pediatric patients with developmental epileptic encephalopathies. The study, conducted at the department of surgery, Charité- Universitätsmedizin Berlin, focused on patients with severe forms of epilepsy and aimed to evaluate the impact of diazepam nasal spray on their treatment and outcomes.

The trial included 173 patients aged 6 to 65 years with a diagnosis of partial or generalized epilepsy who were expected to require benzodiazepine intervention at least 6 times per year. Among them, 64 patients had developmental epileptic encephalopathies. Seven pediatric and 2 adult participants had LGS. Other conditions, such as Rett syndrome and Dravet syndrome, were also part of the sample.

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Most seizure clusters (81.6% to 95.9%) were successfully treated with a single dose, and only a small proportion required a second dose within 24 hours. The high retention rates (77.8% to 100%) in all patient groups up to the study’s closure further supported the treatment’s effectiveness.

Safety analyses revealed that treatment-emergent adverse events were common in patients with developmental epileptic encephalopathies. However, serious treatment-emergent adverse events occurred less frequently in patients with Rett syndrome and more frequently in those with Dravet syndrome. Notably, no reports of respiratory depression were observed. 

“Moreover, analysis of groups with specific encephalopathies, Rett syndrome, Lennox-Gastaut syndrome, and Dravet syndrome, identified no additional safety concerns, and no patients discontinued the study owing to treatment-related treatment-emergent adverse events,” the authors noted.


Tarquinio D, Wheless J, Segal E, et al. Safety of diazepam nasal spray in pediatric patients with developmental epileptic encephalopathies: results from a long-term phase 3 safety study. J Child Neurol. Published online July 16, 2023. doi:10.1177/08830738231185424