FDA Approval for Kids
Valtoco (diazepam nasal spray) is FDA-approved for pediatric patients aged 2 to 5 years weighing at least 10 kg for acute treatment of seizure clusters. It's also approved for children 6 years and older.[1][2]
How It's Dosed in Children
Dosing is weight-based: 5 mg (10-19 kg), 10 mg (20-49 kg), 15 mg (50-87 kg), or 20 mg (88+ kg). One spray per nostril delivers the dose. Maximum two doses 10 minutes apart; call emergency services if seizures continue.[1]
Common Side Effects in Pediatrics
Sleepiness, headache, nasal discomfort. Serious risks include respiratory depression, especially if combined with opioids or alcohol. Monitor breathing closely after use.[1][2]
Safety Studies and Data
Approval based on pharmacokinetic bridging studies in kids 2-17 years, showing similar exposure to adults. No new safety signals beyond known diazepam risks like dependence with repeated use. Long-term safety unknown for frequent dosing.[1][3]
When to Avoid or Use Caution
Not studied in kids under 2 years or under 10 kg. Avoid in acute narrow-angle glaucoma, severe respiratory issues, or with strong CYP3A4 inhibitors. Taper if stopping chronic use to prevent withdrawal.[1]
Comparisons to Alternatives
Versus rectal diazepam (Diastat): Valtoco is needle-free, faster-acting for some. Vs. intranasal midazolam (Nayzilam): Similar approval (ages 12+), but Valtoco covers younger kids.[2]
[1]: FDA Valtoco Label
[2]: Drugs.com Valtoco
[3]: Neurelis Safety Data