癫痫是一种大脑慢性神经疾病。它是世界上第四大神经疾病，大约影响6500万人的生活。据估计，在美国有15万癫痫患者会出现集群性癫痫发作。急性治疗集群性癫痫发作非常关键，因为如果不加以治疗，集群性癫痫发作会提高患者出现身体受伤、神经损伤，和长时间癫痫发作的风险。然而，已有的癫痫治疗方法并不适用于治疗集群性癫痫发作，导致很多患者没有接受治疗。

Nayzilam是一种治疗集群性癫痫发作的短期疗法。患者可以携带这种一次性的鼻喷雾剂。它可以由非医护专业人士给正在癫痫发作的患者使用。它的主要成分是苯二氮卓（benzodiazepine）。

Nayzilam的批准是基于一项随机双盲，含安慰剂对照的临床试验结果。201名患者在出现集群性癫痫发作之后，接受了Nayzilam或安慰剂的治疗。试验结果表明，Nayzilam组患者中更多患者在接受治疗10分钟内发作停止（80.6%比70.1%）。同时更多患者在第一次发作后10分钟到6个小时内没有癫痫复发（58.2%比37.3%）。

“集群性癫痫发作通常严重影响患者的生活质量，而且可能导致他们住院和出现严重癫痫症状的风险增加，”Banner大学医学中心癫痫项目主任Steven S. Chung博士说：“治疗集群性癫痫发作是很多患者面对的重要挑战。Nayzilam为改善患者和他们家人的生活提供了一款新的治疗选择。”

癫痫是一种大脑慢性神经疾病。它是世界上第四大神经疾病，大约影响6500万人的生活。据估计，在美国有15万癫痫患者会出现集群性癫痫发作。急性治疗集群性癫痫发作非常关键，因为如果不加以治疗，集群性癫痫发作会提高患者出现身体受伤、神经损伤，和长时间癫痫发作的风险。然而，已有的癫痫治疗方法并不适用于治疗集群性癫痫发作，导致很多患者没有接受治疗。

Nayzilam是一种治疗集群性癫痫发作的短期疗法。患者可以携带这种一次性的鼻喷雾剂。它可以由非医护专业人士给正在癫痫发作的患者使用。它的主要成分是苯二氮卓（benzodiazepine）。

Nayzilam的批准是基于一项随机双盲，含安慰剂对照的临床试验结果。201名患者在出现集群性癫痫发作之后，接受了Nayzilam或安慰剂的治疗。试验结果表明，Nayzilam组患者中更多患者在接受治疗10分钟内发作停止（80.6%比70.1%）。同时更多患者在第一次发作后10分钟到6个小时内没有癫痫复发（58.2%比37.3%）。

“集群性癫痫发作通常严重影响患者的生活质量，而且可能导致他们住院和出现严重癫痫症状的风险增加，”Banner大学医学中心癫痫项目主任Steven S. Chung博士说：“治疗集群性癫痫发作是很多患者面对的重要挑战。Nayzilam为改善患者和他们家人的生活提供了一款新的治疗选择。”

Nayzilam

Generic Name: midazolam
Dosage Form: Nasal Spray
Date of Approval: May 17, 2019
Company: UCB

Treatment for: Seizure Clusters

Medication Guide

Read this Medication Guide before you start treatment with this medicine. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

Important information

Nayzilam is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.

Nayzilam may cause serious breathing problems and excessive sleepiness (sedation). Get emergency medical help right away if any of the following occur:

· unusually shallow or slowed breathing

· stop breathing, which may lead to your heart stopping

· unusually excessive sleepiness

Like other antiepileptic drugs, Nayzilam may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

· thoughts about suicide or dying

· feeling agitated or restless

· acting aggressive, being angry, or violent

· attempts to commit suicide

· panic attacks

· acting on dangerous impulses

· new or worse depression

· trouble sleeping (insomnia)

· an extreme increase in activity and talking (mania)

· new or worse anxiety

· new or worse irritability

· other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts or actions?

· Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.

· Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is Nayzilam?

· Nayzilam is a prescription medicine used for the short-term treatment of seizure clusters (also known as “acute repetitive seizures”) in patients 12 years of age and older.

· Nayzilam is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse. Selling or giving it away 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 this medicine is safe and effective in children under 12 years of age.

Who should not use Nayzilam?

Do not use Nayzilam if you:

· are allergic to midazolam.

· have an eye problem called acute narrow-angle glaucoma.

Before you use Nayzilam

Before you use Nayzilam, tell your healthcare provider about all your medical conditions, including if you:

· have a history of depression, mood problems or suicidal thoughts or behavior.

· have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.

· have kidney or liver problems.

· have congestive heart failure.

· have a history of drug or alcohol abuse.

· are pregnant or plan to become pregnant. Nayzilam may harm your unborn baby.

o Babies born to mothers receiving benzodiazepine medicines (including Nayzilam) late in pregnancy may be at risk of having breathing problems, feeding problems, dangerously low body temperature, and withdrawal symptoms.

o If you become pregnant while using Nayzilam, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. You can register by calling 1-888-233-2334. For more information about the registry, go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.

· are breastfeeding or plan to breastfeed. Midazolam passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you use Nayzilam.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking Nayzilam with certain other medicines can affect each other, causing side effects. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

How should I use Nayzilam?

· Use Nayzilam in the nose only.

· Use this medicine exactly as your healthcare provider tells you to use it and follow the Instructions for Use that comes with your prescription.

· Your healthcare provider has prescribed Nayzilam to treat a type of seizure called a “seizure cluster”.

· If the seizure cluster is continuing 10 minutes after the first dose of Nayzilam, a second dose may be used if you have been told to do so by your healthcare provider.

· If a second dose is used, give the second dose in the other nostril.

· Do not give more than 2 doses to treat a seizure cluster.

· If the seizures do not stop after Nayzilam is used, get emergency medical help right away.

· Do not use Nayzilam for more than one seizure cluster episode every three days. Do not use Nayzilam for more than five seizure cluster episodes per month.

· If benzodiazepines are stopped after a person takes them daily, they can cause withdrawal symptoms. Stopping benzodiazepines suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps. Nayzilam is not intended to be taken daily.

· If you use too much or overdose, call your healthcare provider or go to the nearest emergency room right away.

What should I avoid while using Nayzilam?

· Do not drive, operate machinery, or do other activities that require mental alertness until you know how Nayzilam affects you.

· Do not drink alcohol or take opioid medicines or other medicines that make you sleepy or dizzy while taking Nayzilam until you talk to your healthcare provider. When taken with alcohol or medicines that can cause sleepiness or dizziness, Nayzilam may make your sleepiness or dizziness worse.

Nayzilam side effects

Nayzilam may cause serious side effects, including:

· See Important information for information on serious side effects of:

o interaction with other central nervous system depressants

o serious breathing problems and excessive sleepiness

o suicidal thoughts or actions

· Impaired mental alertness including memory problems. See What should I avoid while using Nayzilam?

· Increase in eye pressure in people with acute narrow-angle glaucoma. See Who should not take Nayzilam?

The most common side effects include:

· sleepiness

· headache

· runny nose

· nasal discomfort

· throat irritation

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Nayzilam?

· Store Nayzilam at room temperature between 68°F to 77°F (20°C to 25°C).

· Store in the blister package until ready to use.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Nayzilam.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Nayzilam?

Active ingredient: midazolam

Inactive ingredients: ethanol, PEG-6 methyl ether, polyethylene glycol 400, propylene glycol and purified water