ythan in clinical trials for psychiatric or other conditions, but the absolute risk differences weresimilar for the epilepsy and psychiatric indications.
Anyone considering prescribing midazolam or any other AED must balance the risk ofsuicidal thoughts or behaviors with the risk of untreated illness. Epilepsy and many otherillnesses for which AEDs are prescribed are themselves associated with morbidity andmortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughtsand behavior emerge during treatment, the prescriber needs to consider whether theemergence of these symptoms in any given patient may be related to the illness being treated.
5.5 Impaired Cognitive Function
Midazolam, including NAYZILAM, is associated with a high incidence of partial orcomplete impairment of recall for several hours following an administered dose. Gross testsof recovery from the effects of midazolam cannot be relied upon to predict reaction timeunder stress. It is recommended that no patient operate hazardous machinery or a motorvehicle until the effects of the drug, such as drowsiness, have subsided, and as their medicalcondition permits. For pediatric patients, particular care should be taken to ensure safeambulation.
5.6 Glaucoma
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Benzodiazepines, including NAYZILAM, can increase intraocular pressure in patients withglaucoma. Measurements of intraocular pressure in patients without eye disease show amoderate lowering following induction with midazolam. NAYZILAM may be used inpatients with open-angle glaucoma only if they are receiving appropriate therapy. Patientswith open-angle glaucoma may need to have their ophthalmologic status eva luated followingtreatment with NAYZILAM. NAYZILAM is contraindicated in patients with narrow-angleglaucoma.
5.7 Other Adverse Reactions
When midazolam was used for sedation, reactions such as agitation, involuntary movements(including tonic/clonic movements and muscle tremor), hyperactivity, and combativeness havebeen reported . These reactions may be caused by inadequate or excessive dosing or improperadministration of midazolam; however, consideration should be given to the possibility ofcerebral hypoxia or true paradoxical reactions.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in more detail in other sections of thelabeling:
Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1)]
Risks of Cardiorespiratory Adverse Reactions [see Warnings and Precautions (5.2)]
CNS Depression from Concomitant Use with Other CNS Depressants or Moderate orStrong CYP3A4 Inhibitors [see Warnings and Precautions (5.3)]
Suicidal Behavior and Ideation [see Warnings and Precautions (5.4)]
Impaired Cognitive Function [see Warnings and Precautions (5.5)]
Glaucoma [see Warnings and Precautions (5.6)]
Other Adverse Reactions [see Warnings and Precautions (5.7)]
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved in the clinical trials of a drug cannot be directly compared to rates in the clinicaltrials of another drug and may not reflect the rates observed in clinical practice.
NAYZILAM was studied for the outpatient treatment of a single seizure cluster in 292 adultand adolescent patients with epilepsy (Study 1) [see Clinical Studies (14)]. The study wasconducted in two phases; an open-label Test Dose Phase fol |
