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Nayzilam

Last reviewed on RxList: 5/22/2019
Nayzilam Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/22/2019

Nayzilam (midazolam) is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 12 years of age and older. Common side effects of Nayzilam include:

  • drowsiness,
  • headache,
  • nasal discomfort,
  • throat irritation, and
  • runny nose

The initial dose of Nayzilam is one spray (5 mg dose) administered into one nostril. A second dose of one additional spray (5 mg dose) Nayzilam may be administered into the opposite nostril after 10 minutes if the patient has not responded to the initial dose. Nayzilam may interact with other drugs that can make you sleepy (other benzodiazepines and sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, opioids, alcohol), ketoconazole, itraconazole, and clarithromycin. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Nayzilaml it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Nayzilam, during pregnancy. Nayzilam passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Nayzilam.

Our Nayzilam (midazolam) Nasal Spray Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Nayzilam Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Midazolam nasal can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, if you are hard to wake up, or if you stop breathing.

Call your doctor right away or seek emergency medical help if you have:

  • extreme drowsiness;
  • a weak pulse;
  • mood or behavior changes, depression;
  • agitation, anxiety, panic, trouble sleeping, feeling irritable; or
  • thoughts about suicide or hurting yourself.

Common side effects may include:

  • drowsiness;
  • headache;
  • runny nose, discomfort in your nose; or
  • throat irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nayzilam (Midazolam Nasal Spray)

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Nayzilam Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

  • Risks from Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS]
  • Risks of Cardiorespiratory Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • CNS Depression from Concomitant Use with Other CNS Depressants or Moderate or Strong CYP3A4 Inhibitors [see WARNINGS AND PRECAUTIONS]
  • Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
  • Impaired Cognitive Function [see WARNINGS AND PRECAUTIONS]
  • Glaucoma [see WARNINGS AND PRECAUTIONS]
  • Other Adverse Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials 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 adult and adolescent patients with epilepsy (Study 1) [see Clinical Studies]. The study was conducted in two phases; an open-label Test Dose Phase followed by a double-blind, placebo-controlled, Comparative Phase. The mean age of patients enrolled in the Comparative Phase (N=201) was 33 years, 51% were female, and 95% were White.

Table 2 lists the adverse reactions occurring in 2% or more of the NAYZILAM-treated patients and at a rate greater than the placebo-treated patients in the Comparative Phase of Study 1.

Table 2: Adverse Reactionsa that Occurred in ≥2% of Patients (Any NAYZILAM) and Greater than Placebo in the Comparative Phase of Study 1

Body System/Adverse Reaction Placebo NAYZILAMb
NAYZILAM
5 mg
Placebo + NAYZILAM
5 mg
NAYZILAM
5 mg + 5 mg
Any NAYZILAM
Treatment Group
  N = 26
%
N = 91
%
N = 41
%
N = 43
%
N = 175
%
Nervous System          
  Somnolence 4 10 10 9 10
  Headache 0 7 0 2 4
  Dysarthria 0 2 2 2 2
Application Site          
  Nasal Discomfort 8 5 7 16 9
  Throat Irritation 0 2 2 7 3
  Rhinorrhea 0 3 0 5 3
  Product Taste Abnormal 0 4 0 0 2
Eye Disorders          
  Lacrimation Increased 0 1 2 2 2
a Adverse reactions that occurred within 2 days after NAYZILAM administration are included
b Patients in Study 1 were permitted to take a second, open-label dose of NAYZILAM 5 mg between 10 minutes and 6 hours following the initial blinded dose of NAYZILAM 5 mg or placebo if they experience seizure recurrence or an incomplete resolution of the episode. The Placebo + NAYZILAM 5 mg and NAYZILAM 5 mg + 5 mg columns represent patients who received a second dose of NAYZILAM 5 mg and received a blinded initial dose of placebo or NAYZILAM 5 mg, respectively.

For patients who experienced a decrease in peripheral oxygen saturation in the Test Dose Phase of Study 1, the decreases were generally transitory. Two patients (one with a history of sleep apnea and one with intercurrent seizure) with decreases in peripheral oxygen saturation in the Test Dose Phase required therapeutic supplemental oxygen.

Read the entire FDA prescribing information for Nayzilam (Midazolam Nasal Spray)

SLIDESHOW

Epilepsy: Symptoms, Causes and Treatment See Slideshow
Related Resources for Nayzilam

© Nayzilam Patient Information is supplied by Cerner Multum, Inc. and Nayzilam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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