What is Nayzilam?
Nayzilam is a nasal spray formulation of midazolam, a benzodiazepine used to treat seizure clusters in patients aged 12 and older. It provides rapid absorption through the nasal mucosa to stop or shorten prolonged or repetitive seizures, such as those in epilepsy. The FDA approved it in 2019 for acute use outside medical settings, administered by caregivers.[1]
How does Nayzilam work?
Midazolam enhances the activity of GABA, an inhibitory neurotransmitter, in the brain. This hyperpolarizes neurons, reducing seizure activity within 10 minutes for most users, with peak effects around 20-30 minutes. A single 5 mg or 10 mg dose (depending on weight) is sprayed into one nostril; a second dose can be given after 10 minutes if seizures persist.[1]
Who makes Nayzilam and when did it launch?
UCB Inc., a biopharmaceutical company focused on neurology, developed and markets Nayzilam. It launched in the U.S. in late 2019 following approval on May 17, 2019. It's available by prescription only, often covered under insurance for epilepsy patients.[1]
When does Nayzilam's patent expire?
Nayzilam's key patents cover the nasal spray formulation and delivery method, listed on DrugPatentWatch.com. The primary composition-of-matter patent (U.S. Patent 8,263,096) expires in 2027, but formulation patents extend protection to 2033-2035, with pediatric exclusivity potentially adding six months. No generic approvals are pending as of now.[2]
How does Nayzilam compare to other seizure rescue treatments?
Unlike rectal diazepam (Diastat), Nayzilam is non-invasive and faster for home use. Valtoco (another nasal midazolam) is a direct competitor with similar efficacy but different dosing (up to three 10 mg sprays). Intranasal options avoid needles, improving compliance over injectable lorazepam. Studies show Nayzilam stops 53% of clusters with one dose versus 34% for Diastat.[1][3]
| Treatment | Route | Onset | Dosing Limit |
|-----------|--------|--------|--------------|
| Nayzilam | Nasal | 10 min | 2 doses/24h |
| Diastat | Rectal | 10-15 min | 1-2 doses/5 days |
| Valtoco | Nasal | 10 min | 3 doses/24h |
What are common side effects and risks?
Most users experience mild effects like drowsiness, nasal discomfort, or headache. Serious risks include respiratory depression (especially with opioids), dependence with overuse, and withdrawal. It's contraindicated in glaucoma or severe lung disease. Overdose requires immediate medical help; nasal spray reduces injection risks but not sedation buildup.[1]
Cost and access details
A single-dose Nayzilam kit costs $600-$900 without insurance, but patient assistance programs from UCB cap copays at $10 for eligible users. It's not over-the-counter; prescribers enroll patients in the Risk Evaluation and Mitigation Strategy (REMS) program for training.[1]
[1]: FDA Label - https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209050s000lbl.pdf
[2]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/NAYZILAM
[3]: Clinical Study (NCT02486476) - https://clinicaltrials.gov/study/NCT02486476