Diazepam Nasal Spray for Acute Repetitive Seizures
Diazepam nasal spray (Valtoco®) is FDA-approved and recommended for acute treatment of seizure clusters in patients with epilepsy aged ≥6 years, offering a rapid, socially acceptable alternative to rectal diazepam with more reliable bioavailability and less pharmacokinetic variability. 1, 2
Primary Indication: Seizure Clusters
Diazepam nasal spray is specifically indicated for acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters, acute repetitive seizures) in patients with epilepsy aged ≥6 years. 1
The intranasal route provides rapid absorption with large absorptive surface area, bypasses first-pass metabolism, and is needle-free and painless compared to rectal administration. 2
Clinical studies demonstrate less pharmacokinetic variability and more reliable bioavailability compared to rectal diazepam gel (Diastat®). 2
Administration and Effectiveness
A single dose is effective in the majority of cases, with only 2.5-17.2% of seizure cluster episodes requiring a second dose across different usage frequencies. 3
The medication can be administered by caregivers or, in appropriate patients, self-administered by the patient themselves. 4
Plasma levels are achieved rapidly after administration in a linear dose-proportional fashion. 5
Safety Profile
The most common treatment-related adverse event is nasal discomfort, with no notable changes in nasal irritation or olfaction observed even with frequent use. 3
Cardiorespiratory depression was not reported in long-term safety studies, even in patients using concomitant benzodiazepines. 6
Study retention rates were high (82.9% overall), indicating good tolerability across all dosing frequencies. 3
Safety profile remains consistent regardless of concomitant benzodiazepine use, including chronic daily benzodiazepine or clobazam therapy. 6
Important Safety Considerations
Monitor oxygen saturation and respiratory effort, as there is increased risk of apnea when diazepam is given rapidly or combined with other sedative agents. 7
Be prepared to support ventilation if necessary, with respiratory assistance facilities readily available during administration. 7
Flumazenil may reverse life-threatening respiratory depression but also counteracts anticonvulsant effects and may precipitate seizures. 7
Potential for paradoxical excitement or agitation, especially in younger patients. 7
Comparison to Other Routes
Intranasal administration is preferred over rectal diazepam due to better social acceptance, ease of use, and more consistent pharmacokinetics. 2
When IV access is unavailable for status epilepticus, rectal diazepam has been the traditional alternative, but intranasal delivery now offers superior convenience. 8
Diazepam buccal film is another alternative that performs equivalently to rectal gel but with less variable peak exposures. 5
NOT Indicated for Anxiety
Diazepam nasal spray is NOT approved for anxiety management—IV diazepam is the appropriate formulation for acute anxiety. 1
For anxiety disorders, the FDA indication specifies management of anxiety disorders or short-term relief of anxiety symptoms, but this applies to oral or IV formulations, not nasal spray. 1
Anxiety or tension associated with everyday stress does not require anxiolytic treatment. 1