What is the recommended use and dosage of Nayzilam (midazolam nasal spray) for treating seizures in patients with epilepsy?

Nayzilam (Midazolam Nasal Spray) for Seizure Management in Epilepsy

Nayzilam (midazolam nasal spray) is recommended at a dose of 5 mg (one spray) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters) in epilepsy patients 12 years and older. 1

Indications and Administration

• Nayzilam is specifically indicated for treating:

  • Intermittent, stereotypic episodes of frequent seizure activity
  • Seizure clusters or acute repetitive seizures
  • Episodes distinct from a patient's usual seizure pattern 2

• Administration guidelines:

  • Initial dose: 5 mg administered as a single spray into one nostril
  • If seizures persist, a second 5 mg dose may be administered at least 10 minutes after the first dose
  • Do not use more than 2 doses to treat a single episode
  • Do not use for more than one episode every 3 days or more than 5 episodes per month 1, 3

Efficacy

• Clinical trials demonstrate that midazolam nasal spray effectively prevents seizure recurrence:

  • 54.8% of patients remain seizure-free for 6 hours following treatment (compared to 38.7% with placebo) 2
  • The seizure-free timespan doubles from a median of 5.0 hours without treatment to 10.67 hours after midazolam nasal spray administration 3
  • Onset of action is rapid, with separation from placebo observed within approximately 1.5 hours post-dose 2

• Intranasal midazolam has shown superior time to seizure control (3.16±1.24 minutes) compared to intravenous diazepam (6.42±2.59 minutes) when accounting for IV line establishment time 4

Safety and Monitoring

• Respiratory monitoring:

  • Oxygen saturation should be monitored continuously during administration
  • Respiratory support equipment should be readily available
  • A decline in oxygen saturation may occur in approximately 17% of cases 3

• Common adverse effects:

  • Nasal mucosal irritation (8.1% of cases)
  • Sedation (5.7% of cases)
  • Nausea and vomiting (2.6% of cases) 3

• Serious adverse events are rare, with respiratory depression occurring in approximately 1% of cases 5

Special Considerations

• Dose adjustments:

  • Reduce dose by at least 20% in patients over 60 years old
  • Lower doses are recommended for patients with hepatic or renal insufficiency
  • Reduce dose when used concomitantly with opioids due to synergistic effects 6

• Cautions:

  • Use with caution in patients with COPD
  • Be aware that H2 antagonists can increase midazolam bioavailability by approximately 30% 6
  • Flumazenil may be used to reverse life-threatening respiratory depression, but with caution as it may precipitate seizure recurrence 6

Advantages Over Other Formulations

• Nayzilam is easy to administer and can quickly treat seizures outside the hospital setting
• The intranasal route allows administration by non-medical personnel, making it more accessible in emergency situations
• It provides a more user-friendly alternative to rectal diazepam, which has been the standard rescue medication 1
• Midazolam is 1.5-3.5 times more potent than diazepam, with a faster onset and shorter duration of action 6

Nayzilam represents an important advancement in acute seizure management, offering patients and caregivers a rapid, effective, and relatively safe option for treating seizure clusters in the outpatient setting.