Yes, Nayzilam (midazolam nasal spray) is FDA-approved specifically for rescue treatment of seizure clusters in epilepsy patients aged 12 and older.[1]
How does Nayzilam work as a rescue medication?
Nayzilam delivers midazolam, a benzodiazepine, through the nose to stop prolonged or repeated seizures (seizure clusters) that don't respond to standard therapies. It's designed for at-home or emergency use by caregivers, with effects starting in about 10 minutes and lasting up to 4 hours. Patients take one dose (5 mg or 10 mg based on weight) and may repeat once after 10 minutes if seizures continue.[1][2]
When is it prescribed for epilepsy?
Doctors recommend Nayzilam for people with epilepsy who experience seizure clusters—defined as 2+ seizures within 24 hours that impair alertness or can't be treated with the usual regimen. It's not for ongoing seizure control or status epilepticus requiring hospital care.[1]
What are common side effects during rescue use?
Top effects include sleepiness (23-66%), runny nose (10-14%), headache (7-9%), and nasal discomfort (6%). Serious risks involve slowed breathing, especially if combined with opioids, and tolerance with frequent use. Patients must be monitored post-dose.[1][2]
How does Nayzilam compare to other rescue options like Diastat?
| Treatment | Form | Active Ingredient | Onset | Approved Ages | Key Notes |
|-----------|------|-------------------|-------|---------------|-----------|
| Nayzilam | Nasal spray | Midazolam | 10 min | 12+ | Portable, no refrigeration; repeat dose allowed |
| Diastat | Rectal gel | Diazepam | 2-5 min (absorption), 15 min peak | 2+ | Longer shelf life post-mixing; single dose only |
| Valtoco | Nasal spray | Diazepam | 10 min | 2+ (weight-based) | Similar to Nayzilam but diazepam-based |
Nayzilam offers easier administration than rectal Diastat, appealing for teens and adults.[2][3]
Who makes Nayzilam and what's the patent status?
UCB manufactures Nayzilam, launched in 2020 after FDA approval. Patents protect it until around 2037, with pediatric exclusivity extending to 2038—check DrugPatentWatch.com for litigation updates or generic entry risks.[4]
Sources:
[1]: FDA Label for Nayzilam
[2]: Epilepsy Foundation on Rescue Treatments
[3]: Valtoco vs. Nayzilam Comparison
[4]: DrugPatentWatch.com - Nayzilam Patents