Intranasal Midazolam Formulation
No, you do not use an "OB formulation" for intranasal midazolam—there is no such thing as an obstetric formulation of midazolam for intranasal use. The term "OB formulation" is not a recognized pharmaceutical designation for midazolam in any route of administration.
What Formulation to Use for Intranasal Administration
For intranasal midazolam administration, use either the FDA-approved intranasal formulation (Nayzilam) or the standard intravenous formulation administered off-label via the intranasal route. 1, 2
FDA-Approved Intranasal Formulation
- Nayzilam (midazolam nasal spray) is the FDA-approved intranasal formulation specifically designed for treating seizure clusters, approved in 2019 as the first nasally administered formulation for this indication. 1, 2
- This formulation is optimized for intranasal delivery with appropriate concentration and delivery device. 2
Off-Label Use of IV Formulation
- The standard intravenous midazolam formulation can be administered intranasally off-label, which has been extensively studied and used in clinical practice, particularly for acute seizure management. 3, 4, 5
- The typical dose is 0.2 mg/kg administered equally in both nostrils for seizure control. 4, 5
- This approach uses the water-soluble IV formulation (pH 3) that midazolam is available in, which allows for mucosal absorption. 6, 3
Clinical Efficacy and Safety
- Intranasal midazolam 0.2 mg/kg is as effective as intravenous diazepam 0.5 mg/kg for controlling acute seizures, especially in children with febrile or afebrile seizures. 3
- The mean time to seizure control with intranasal midazolam is approximately 3.2-3.6 minutes (not counting IV line insertion time for comparison drugs). 4, 5
- Serious side effects like respiratory depression occur in only about 1% of cases, with local mucosal irritation occurring in less than one-third of cases. 3
- No significant differences in oxygen saturation or heart rate have been observed compared to intravenous diazepam. 4
Common Pitfall to Avoid
Do not confuse terminology or create non-existent formulation names. There is no "OB formulation" of midazolam. If you need intranasal midazolam, use either the FDA-approved nasal spray (Nayzilam) or the standard IV formulation administered intranasally at 0.2 mg/kg. 3, 4, 1, 5, 2