Section 01 · Monograph

Midazolam

Reviewed Nov 2026FDA label
Nayzilam / SeizalamBenzodiazepine · rescue
Forms
NS: 5mg/spray (Nayzilam) | IM: 5mg/mL (Seizalam)
Dose
Nayzilam 5mg intranasal, may repeat x1 after 10 min | Seizalam 10mg IM (adult status epilepticus)
MOA
↑GABA-A Cl- channel frequency

Black Box Warning

  • Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma and death
  • Abuse, misuse and addiction risk
  • Dependence and withdrawal reactions

Indications

  • Nayzilam (intranasal): acute treatment of intermittent bouts of increased seizure activity (seizure clusters) in patients 12 years and olderFDA-labeled
  • Seizalam (IM): status epilepticus in adultsFDA-labeled

Mechanism of Action

  • Benzodiazepine that enhances GABA-A receptor chloride channel opening frequency, producing rapid anticonvulsant and sedative effects

Full Dosing

Adult / usual

  • Nayzilam: 5mg (one spray) in one nostril; a second 5mg dose in the opposite nostril at least 10 minutes later if needed; maximum two doses per episode, one episode every 3 days, five episodes per month
  • Seizalam: 10mg IM once for adults over 40kg (5mg for 13-40kg per label)

Contraindications

  • Acute narrow-angle glaucoma
  • Known hypersensitivity to midazolam

Drug Interactions

  • Opioids and other CNS depressants: severe sedation and respiratory depression
  • CYP3A4 inhibitors (ketoconazole, macrolides, protease inhibitors, grapefruit) increase midazolam levels

Adverse Effects

  • Somnolence, headache
  • Nasal discomfort, throat irritation, rhinorrhea (intranasal)
  • Respiratory depression
  • Paradoxical agitation
  • Dependence and withdrawal

Monitoring Parameters

  • Respiratory status and sedation with airway support available
  • Misuse and abuse risk
  • Seizure control

Pregnancy & Lactation

  • Late-pregnancy benzodiazepine exposure can cause neonatal sedation or withdrawal
  • Present in milk; monitor infants for sedation

References

  1. NAYZILAM (midazolam nasal spray) Prescribing Information — DailyMed (NIH) search

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