Nayzilam nasal spray contains midazolam, a benzodiazepine (ben-zoe-dye-AZE-eh-peen).

Nayzilam nasal spray is a prescription medicine used short term to treat seizure clusters (also called "acute repetitive seizures") in adults and children at least 12 years old.

Nayzilam is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or giving away this medicine may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription drugs, or street drugs.

It is not known if Nayzilam is safe and effective in children under 12 years of age.

You should not use Nayzilam nasal spray if you have narrow-angle glaucoma.

MISUSE OF NAYZILAM CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Nayzilam 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.

Do not stop using Nayzilam nasal spray without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use. Some withdrawal symptoms may last up to 12 months or longer.

Get medical help right away if you stop using Nayzilam and have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, or thoughts about suicide.

Some people have thoughts about suicide while using Nayzilam. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Use Nayzilam nasal spray exactly as prescribed by your doctor. Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use Nayzilam in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to use more of this medicine.

Never share this medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Do not take by mouth. This medicine is for use only in the nose.

Be sure you know how to recognize what is and is not a seizure cluster and when it is best to use this medicine. Ask your doctor or pharmacist if you have questions.

Nayzilam nasal spray is usually given as a single spray into one nostril. If you still have seizures 10 minutes after using 1 spray, use a second spray in the opposite nostril.

Get emergency medical help if you have still have seizures after using this medicine.

You should not use a second spray if you have very slow breathing after using the first spray.

Do not use more than 2 sprays of Nayzilam to treat a seizure cluster. Do not use this medicine to treat more than 1 seizure cluster every 3 days, or more than 5 seizure clusters in one month (30 days).

Do not stop using Nayzilam nasal spray without asking your doctor. You may have life-threatening withdrawal symptoms if you stop using the medicine suddenly after long-term use.

Store at room temperature away from moisture and heat, in a place where no one can use it improperly. Keep the spray bottle in the blister pack until you are ready to use the medicine.

Usual Adult Dose for Epilepsy:

Nasal:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose
-Maximum dose: 10 mg/day.

Usual Adult Dose for Seizures:

Nasal:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose.

Usual Pediatric Dose for Epilepsy:

Nasal:
12 years and older:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose
-Maximum dose: 10 mg/day.

Usual Pediatric Dose for Seizures:

Nasal:
12 years and older:
-Initial dose: 5 mg (1 spray) intranasally in 1 nostril ONCE
-Subsequent dose: 5 mg (1 spray) intranasally in the opposite nostril after 10 minutes if the patient has not responded to the initial dose
-Maximum dose: 10 mg/day

Comments:
-This drug should not be used to treat more than 1 episode every 3 days, and no more than 5 episodes/month.
-The subsequent dose should not be administered if the patient has difficulty breathing OR if the patient has sedation that is not typically observed during a seizure cluster episode.

Use: Acute treatment of intermittent, stereotypic episodes of frequent seizure activity (e.g., acute repetitive seizures, seizure clusters) that are distinct from a patient's usual seizure pattern.

You should not use Nayzilam if you are allergic to midazolam, or if you have:

• narrow-angle glaucoma.

To make sure Nayzilam is safe for you, tell your doctor if you have ever had:

• glaucoma;

• depression, or a mood disorder;

• suicidal thoughts or actions;

• drug or alcohol addiction;

• asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;

• congestive heart failure; or

• liver or kidney disease.

Some people have thoughts about suicide while using Nayzilam. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Tell your doctor if you are pregnant or plan to become pregnant. If you use Nayzilam during pregnancy, your baby could be born with life-threatening withdrawal symptoms, and may need medical treatment for several weeks.

Ask a doctor if it is safe to breastfeed while using this medicine.

Since Nayzilam nasal spray is used when needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using this medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of midazolam can be fatal if you take it with alcohol, opioid medicine, or other drugs that cause drowsiness or slow your breathing.

Overdose symptoms may include drowsiness, confusion, muscle weakness, loss of coordination, or coma.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

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

Nayzilam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• weak or shallow breathing;

• confusion, paranoia, thoughts about suicide or hurting yourself;

• a seizure; or

• blurred vision, eye pain or redness, seeing halos around lights.

Common Nayzilam side effects may include:

• drowsiness;

• headache;

• runny nose, discomfort in your nose; or

• throat irritation.

After you stop using Nayzilam, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.

Some withdrawal symptoms may last up to 12 months or longer after stopping this medicine suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.

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.

Using Nayzilam nasal spray with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with midazolam, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.