Nayzilam contains the active ingredient midazolam, a benzodiazepine compound. It is available as a nasal spray formulation, with each single-dose unit delivering 5 mg of midazolam. Key inactive ingredients include ethanol, polyethylene glycol, and propylene glycol. The nasal spray is intended for nasal administration.

How should I use this medication?

This medication is for use in the nose. Take it as directed on the prescription label at the same time every day. Do not use it more often than directed. Make sure that you are using your nasal spray correctly. Ask your care team if you have any questions. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once. NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply.

Where should I keep my medication?

Keep this medication out of reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law. Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store in the blister package until ready to use. Get rid of any unused medication after the expiration date. This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. To get rid of this medication: -Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location. -Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication. - If other options are not available, ask your pharmacist how to get rid of it safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible: -Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat -CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake -Thoughts of suicide or self-harm, worsening mood, feelings of depression Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome): -Dizziness -Drowsiness -Headache -Irritation inside the nose or throat -Runny or stuffy nose

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions: -Glaucoma -Heart disease -Kidney disease -Liver disease -Lung or breathing disease, such as asthma or COPD -Mental health conditions -Sleep apnea -Substance use disorder -Suicidal thoughts, plans, or attempt by you or a family member -An unusual or allergic reaction to midazolam, other medications, foods, dyes, or preservatives -Pregnant or trying to get pregnant -Breastfeeding

What may interact with this medication?

Do not take this medication with any of the following: -Grapefruit juice -Idelalisib -Itraconazole -Lonafarnib -Sodium oxybate This medication may also interact with the following: -Alcohol -Medications that cause drowsiness before a procedure, such as propofol -Medications that help you fall asleep -Medications that relax muscles -Opioids for pain or cough -Other benzodiazepines -Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine -Some antihistamines -Some medications for depression, such as amitriptyline or trazodone -Some medications for seizures, such as phenobarbital or primidone -Supplements, such as green tea, melatonin, St. John's wort, valerian Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Call emergency services if your seizures do not stop after you use this medication. There is a risk of abuse, misuse, and addiction with this medication. It is important to take this medication as directed by your care team. This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. This medication is a CNS depressant. This is a type of medication or substance that slows down your brain and nervous system. Taking it with other CNS depressants can make you too sleepy. This can make it hard to breathe and stay awake. In some cases, it can cause coma and death. CNS depressants include opioids, benzodiazepines, muscle relaxants, medications for sleep, alcohol, and street drugs. Talk to your care team about all the medications, vitamins, and supplements you take. They can tell you what is safe to take together. Call emergency services right away if you have slow or shallow breathing, feel dizzy or confused, or have trouble staying awake. This medication is used to treat higher than usual seizure activity. It is not for daily use. If you have taken this medication for a long time or take a high dose, your body may rely on it. Stopping it suddenly may cause a severe reaction. When it is time to stop, the dose will be slowly lowered over time to reduce the risk of side effects. This medication may worsen depression and cause thoughts of suicide. This can happen at any time but is more common after first starting treatment and after a change in dose. Talk to your care team right away if you have changes in mood and behavior or thoughts of self-harm or suicide. They can help you. Wear a medical ID bracelet or chain. Carry a card that describes your condition. List the medications and doses you take on the card. Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause temporary withdrawal in a newborn.

What are the most serious risks of this medication?

Do not stop taking this medication or reduce your dose without first talking to your care team. If you have taken this medication for a long time or take a high dose, your body may rely on it. Taking the medication away too quickly can cause symptoms, such as anxiety, tremors, and trouble sleeping. In severe cases, hallucinations and seizures can occur. Talk to your care team about how long you need to take this medication. When it is time to stop, the dose will be slowly lowered over time to reduce the risk of side effects.