Midazolam (nasal)

Midazolam is a benzodiazepine (ben-zoe-dye-AZE-eh-peen) that is used for a short time to treat seizure clusters (also known as "acute repetitive seizures") in adults and children who are at least 12 years old.

Midazolam may also be used for reasons not mentioned in this medication guide.

Midazolam nasal can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol.

MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep this medicine where others cannot get to it.

Do not stop using midazolam nasal 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 midazolam nasal 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 taking midazolam nasal. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

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

• narrow-angle glaucoma.

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 taking midazolam nasal. 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 midazolam nasal 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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 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.

Midazolam may cause serious side effects. 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 side effects of midazolam may include:

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

After you stop using midazolam nasal, 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 midazolam 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.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use midazolam nasal 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.

Midazolam 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 midazolam nasal 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 midazolam nasal 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.

Since midazolam (nasal) is used as needed, it does not have a daily dosing schedule. Call your doctor if your symptoms do not improve after using midazolam (nasal).

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. Taking too much midazolam (nasal) can be deadly if you use it with alcohol, opioid medicine, or other drugs that make you sleepy or slow your breathing.

Signs of an overdose may include drowsiness, confusion, muscle weakness, loss of coordination, or coma.

Do not drink alcohol. Serious side effects or death could happen.

Avoid driving or doing risky activities until you understand how midazolam (nasal) affects you. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Using midazolam with other drugs that slow your breathing can lead to serious side effects or death. Talk to your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may influence how midazolam (nasal) works, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.