Nayzilam

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 the following symptoms while using midazolam or after you stop using it:

• extreme drowsiness;
• unusual muscle movements, or a seizure;
• sudden mood or behavior changes, hallucinations;
• agitation, anxiety, panic, trouble sleeping, feeling irritable; or
• depression, thoughts about suicide or hurting yourself.

Some people who stopped using this medicine suddenly had withdrawal symptoms lasting up to a year or longer, including: anxiety, problems with thinking or memory, depression, ringing in your ears, trouble sleeping, muscle twitching, or a burning, prickling, or crawling sensation. Ask your doctor how to safely stop using this medicine.

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)

 

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 Reactions* that Occurred in ≥2% of Patients (Any NAYZILAM) and Greater than Placebo in the Comparative Phase of Study 1

Body System/Adverse Reaction	Placebo N = 26%	NAYZILAM†
		NAYZILAM 5 mg N = 91 %	Placebo + NAYZILAM 5 mg N = 41 %	NAYZILAM 5 mg + 5 mg N = 43 %	Any NAYZILAM Treatment Group 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
*Adverse reactions that occurred within 2 days after NAYZILAM administration are included † 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)

&Copy; 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.