Study and Author (year) Groups Studied and Intervention Results and Findings Conclusions
Safety and Efficacy of midazolam nasal spray in the outpatient treatment of patients with seizure clusters: Detyniecki et al. (2019)[@147645] 201 patients, 12 years old to 65 years old, median age of 33.0 (SD:11.96) administered intranasal midazolam (134 patients) or placebo (67 patients). Seizure Cessation within 10 minutes of drug administration:
Intranasal midazolam: 53.7 % of patients
Placebo group: 34.4% of patients
Intranasal midazolam has shown rapid and persistent seizure control, with minimal safety risks, in patients greater than 12 years old, making it the preferred treatment choice for seizure control in a prehospital setting.
Pharmacokinetics, pharmacodynamics, and tolerability of USL261, midazolam nasal spray: Berg et al. (2017)[@147647] 30 patients, 18 geriatric (range: 65-78 y/o) and 12 non-geriatric (range: 20-40 y/o) administered intranasal midazolam 2.5 mg and 5.0 mg. Intranasal midazolam 2.5 mg: 12 patients (40%) experienced increased lacrimation, 9 patients (30%) experienced throat irritation.
Intranasal midazolam 5.0 mg: 12 patients (40%) experienced increased lacrimation, 9 patients (30%) experienced dysgeusia.
No serious adverse events were seen.
Intranasal midazolam 2.5 mg and 5.0 mg showed only mild treatment emergent adverse events (TEAEs) in both geriatric and non-geriatric populations, making this drug a safe choice for patients of all ages.
Efficacy, tolerability, and safety of concentrated intranasal midazolam spray as emergency medication in epilepsy patients during video-EEG monitoring: von Blomberg et al. (2020)[@147648] 243 patients with epilepsy, mean age of 35.5 years (range: 5-76 years), receiving intranasal midazolam 5.0 mg or not receiving intranasal midazolam (controls) for seizure treatment. Median seizure-free timespan after treatment:
10.67 hours following intranasal midazolam
5.00 hours in controls
Side Effects: irritation of nasal mucosa [37 cases (8.1%)], prolonged sedation [26 cases (5.7%)], nausea and vomiting [12 cases (2.6%)].
Intranasal midazolam is both safe and efficient in the treatment and short-term prevention of seizure activity. Administration can be accomplished quickly, and severe adverse events are rare.
Intranasal midazolam as first-line in hospital treatment for status epilepticus: a pharmaco-EEG cohort study: Kay et al. (2019)[@147652] 42 patients experiencing status epilepticus (SE), mean age of 52.7 ± 22.7 years, treated with a median dose of 5 mg of intranasal midazolam. Cessation of SE following administration of intranasal midazolam:
24 patients (57.1%)
Time to SE cessation on EEG:
5:05 (minutes:seconds) on average (median: 04:56; range: 00:29 – 14:53)
Adverse events: Nasal irritations (5 patients, 11.9%), prolonged sedation (1 patient, 2.6%)
Intranasal midazolam is an effective treatment for patients experiencing status epilepticus. Adverse events are rarely seen with intranasal midazolam use, and they are mild when present. The intranasal route of administration provides rapid relief of status epilepticus.
Intranasal midazolam for the treatment of seizures in children in rural India: Babbar et al. (2020)[@147653] 50 pediatric patients experiencing seizure activity for > 3 minutes, age range of 6 months to 14 years, administered intranasal midazolam by a caregiver. Average duration of seizure abortion:
Before administration of intranasal midazolam: 16.22 min
After administration of intranasal midazolam: 4.66 min
Seizures aborted in 45/50 children (90%) within 10 minutes.
Intranasal midazolam represents a quick and efficacious method of seizure termination in the pediatric population. The intranasal administration provides an easy option for caregivers who are not medically trained.