Nayzilam Shortage: A Provider's Perspective

Nayzilam (Midazolam nasal spray, 5 mg) has faced intermittent supply disruptions that directly impact epilepsy patients who depend on it as a seizure cluster rescue therapy. This article provides an evidence-based overview for neurologists, epileptologists, emergency physicians, and other prescribers navigating the current shortage landscape in 2026.

Background: Nayzilam in Clinical Practice

Nayzilam received FDA approval in May 2019 for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters/acute repetitive seizures) in patients aged 12 years and older. As an intranasal benzodiazepine, it represents a significant advancement over rectal Diazepam (Diastat) in terms of patient dignity, caregiver ease of use, and community-setting practicality.

Key pharmacological characteristics:

• Active ingredient: Midazolam, 5 mg per single-use nasal spray device
• Mechanism: GABA-A receptor positive allosteric modulator with rapid anticonvulsant activity
• Onset: Intranasal absorption provides relatively rapid onset compared to oral benzodiazepines
• Dosing: 5 mg (one spray, one nostril); second dose may be administered in the contralateral nostril after 10 minutes if seizure cluster persists; maximum 2 doses per episode, no more than 1 episode treated every 3 days, no more than 5 episodes per month
• DEA Schedule: CIV

For a comprehensive clinical overview, see Nayzilam mechanism of action explained.

Current Supply Situation

Nayzilam is manufactured solely by UCB Pharma with no FDA-approved generic equivalent as of 2026. This single-source status creates inherent supply vulnerability. Contributing factors to ongoing availability challenges include:

• Manufacturing concentration: Single production facility with no redundancy
• Complex formulation: Nasal spray delivery systems require specialized manufacturing capabilities
• Controlled substance logistics: Schedule IV classification adds regulatory complexity to distribution
• Specialty pharmacy channeling: Limited retail pharmacy stocking reduces point-of-care accessibility

Providers should monitor the FDA Drug Shortage Database and ASHP Drug Shortage Resource Center for official shortage designations and estimated resolution timelines.

Clinical Impact Assessment

The consequences of Nayzilam unavailability extend beyond patient inconvenience:

• Seizure risk: Patients without rescue therapy face increased risk of prolonged seizure clusters, status epilepticus, and seizure-related injury
• Emergency department utilization: Without outpatient rescue medication, patients are more likely to present to the ED during seizure events
• Patient anxiety: The psychological burden of lacking rescue medication can exacerbate seizure frequency in some patients
• Caregiver burden: Families managing epilepsy in pediatric or dependent adult patients face heightened stress

Therapeutic Alternatives

When Nayzilam is unavailable, consider the following alternatives based on clinical context:

Valtoco (Diazepam Nasal Spray)

The most clinically analogous alternative. FDA-approved for seizure clusters in patients aged 6 years and older. Available in 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg doses. Same intranasal route of administration. Different benzodiazepine pharmacokinetics (longer half-life than Midazolam).

Diastat (Diazepam Rectal Gel)

Established efficacy with decades of clinical use. Available as a generic (cost advantage). Rectal administration presents significant practical and dignity barriers, particularly in adolescent and adult populations, school settings, and public environments.

Off-Label Benzodiazepine Options

Oral or sublingual Lorazepam may serve as an interim rescue option, though the slower onset of oral administration limits utility during active seizure clusters. Injectable Midazolam (IM) could be considered in select cases where a trained caregiver is available, though this requires careful patient/caregiver education.

For patient-facing information on alternatives, refer patients to: Alternatives to Nayzilam if you can't fill your prescription.

Prescribing Strategies During the Shortage

1. Proactive prescribing: Write prescriptions with adequate refills and advise patients to request refills 2-3 weeks before supply depletion
2. Dual rescue therapy: Consider prescribing both Nayzilam and an alternative (e.g., Valtoco or generic Diastat) so patients have a backup
3. Specialty pharmacy routing: Direct prescriptions to specialty pharmacies with established Nayzilam supply chains
4. Prior authorization preparation: Proactively submit prior authorizations and maintain documentation supporting medical necessity
5. Pharmacy finder tools: Direct patients and staff to MedFinder for Providers to identify pharmacies with current stock

Insurance and Access Considerations

Many commercial and government payers require prior authorization for Nayzilam. During documented shortages, consider:

• Requesting expedited exception reviews for alternative medications
• Documenting the shortage with pharmacy confirmation for appeals
• Utilizing UCB Pharma's patient support program (UCBCares) for access assistance
• Referring eligible patients to the manufacturer savings card at nayzilam.com/savings

For detailed prescriber guidance on cost and access, see how to help patients save money on Nayzilam.

Patient Communication Recommendations

Transparent communication is essential during medication shortages:

• Proactively inform patients of potential supply issues at appointments
• Provide written action plans that include both primary and backup rescue medications
• Share patient-facing resources including the patient shortage update and tips for finding Nayzilam in stock
• Ensure patients understand when to call 911 versus when to use rescue medication

Looking Forward

The introduction of generic Midazolam nasal spray would significantly improve supply resilience and reduce cost barriers. Until then, a multi-pronged approach combining proactive prescribing, dual rescue therapy strategies, and utilization of pharmacy finder tools like MedFinder offers the best framework for managing patient access during intermittent supply disruptions.

For additional provider resources, see our companion article: How to help your patients find Nayzilam in stock.