Midazolam Nasal

Midazolam (mih-DAZ-oh-lam) nasal spray 

Midazolam is a rescue medication that is approved for use:

  • For short-term treatment of increased or frequent seizures called seizure clusters or acute repetitive seizures.
  • In children over 12 years old and in adults.
  • It is not supposed to be taken daily.
  • This medicine does not take the place of your daily seizure medicine.
Nayzilam

Nayzilam (midazolam) nasal spray made by UCB

Intranasal Spray
Medication - Nayzilam nasal spray

Each dose is 5 mg and comes in a device to give the medicine by spray into a nostril.

Used to treat

Absence Seizures
Atonic Seizures
Atypical Absence Seizures
Clonic Seizures
Focal Impaired Awareness or Complex Partial Seizures
Febrile Seizures
Myoclonic Seizures
Secondarily Generalized Seizures or Bilateral Tonic Clonic Seizure
Focal Aware or Simple Partial Seizure
Tonic Seizures
Tonic-clonic Seizures
Unknown Onset

Dosing

  • Each nasal spray device has 5 milligrams (mg) in 0.1 milliliters (mL) of solution.
  • Usually prescribed as 1 spray into one nostril.
  • If seizures continue after 10 minutes, a second spray may be given into the other nostril, if prescribed by the health care provider.
  • Do not use more than 2 doses to treat one seizure cluster, unless specifically instructed by your healthcare provider.
  • Don’t use it more often than once every 3 days or more than 5 times a month, without specific instructions from your health care team.

Note: A test dose of nasal midazolam may be recommended by your health care provider to see how you react to the medicine. This may be done if a person is at risk for breathing problems or slowed breathing from medicines like midazolam. A test dose means that the medicine is given when the person is not having a seizure and/or a health care provider is available to see how the drug is tolerated.

How to take and store Midazolam Nasal?

How to take:

  • Take midazolam nasal spray exactly as your health care provider prescribes it.
    • Start with one spray into one nostril.
    • A second spray may be used 10 minutes later, if prescribed by the health care provider.
    • If a seizure cluster or seizure continues, get emergency medical help.
  • Each midazolam nasal spray device is to be used once – do not test it or push the plunger to prime it before using it.
    • When it’s time to use the nasal spray, hold the device with one finger on each side of the nozzle on the finger grips.
    • Place the nozzle into one nostril until your fingers touch the end of your nose.
    • Push the plunger in to spray the medicine into the nose.
    • If you use a second dose, put the medicine into the other side of the nose.
  • If you use too much Nayzilam, call your healthcare provider or go to the nearest emergency room right away.
  • If a person has trouble breathing or is too sleepy after the first dose (and these symptoms are unusual for them during a seizure or cluster), do not give the second dose. Call your provider for further instructions or get medical help right away.
  • Do not use nasal midazolam daily. If a medicine like midazolam or other benzodiazepine is used every day and then stopped suddenly, withdrawal symptoms may occur. Stopping a medicine like this suddenly may also cause worsening of seizures and seizure emergencies.
    • Using this medicine daily could also make it less effective over time.

How to store:

  • Keep nasal midazolam at room temperature, between 68 and 77 degrees Fahrenheit (20 to 24 degrees Celsius).
  • Keep this medicine in the original blister package until it is used. Put it where it will be easily available when you need it for a seizure cluster.
  • Store this medicine in a safe place, out of reach of children, and away from anyone who could misuse or abuse it.
How does Midazolam Nasal affect the brain?

The exact way that midazolam works in the brain is unknown. It appears to suppress or stop seizures by increasing the way gamma-aminobutyric acid (GABA) acts in the brain. GABA is a major substance or neurotransmitter in the brain. 

Please see package insert.

How does the body digest Midazolam Nasal?

How the body absorbs and breaks down or gets rid of a medicine is called metabolism. The way the body metabolizes a medicine affects how often it is taken and how it works in the brain. This can also affect if it will interact with other medicines. If a person has liver or kidney problems, a person's metabolism may be affected.

Important points about midazolam include:

  • Midazolam is well absorbed after it is given into the nose. 
  • It reaches peak amounts in the blood in about 17 minutes.
  • The half-life in adults is between 2 to 6 hours. A half-life refers to how long it takes for the body to get rid of half of the drug. 
  • Most of Midazolam (89%) and its major active metabolite is bound to proteins in the blood stream.
  • Midazolam is broken down in the liver and excreted in the urine.
How well does the Midazolam Nasal work?

Nayzilam was studied in people 12 years and older to see how well it prevented another seizure in a cluster. People using Nayzilam were compared to people who used a placebo in a major study of this drug. 

  • People were first given 2 doses of Nayzilam to see how they reacted to the medicine.
  • They were then given either 5 mg of Nayzilam or a placebo to treat a seizure cluster.
  • Seizure clusters stopped in a significantly greater number of people using Nayzilam than those using placebo. 
    • The seizure cluster stopped within 10 minutes in about half of the people using Nayzilam. The seizures did not come back in the next 6 hours.  
    • The seizure cluster stopped within 10 minutes in about 1/3 of people using a placebo and did not come back within 6 hours. 

 

What are the most common side effects of Midazolam Nasal?

Some common side effects include:

  • sleepiness
  • headache
  • runny nose
  • nasal discomfort
  • throat irritation

Write down any side effects that happen and tell your health care provider. Sometimes it is hard to tell if a side effect is due to the seizures or to the medicine.

What are the most serious side effects of Midazolam Nasal?

Very few people have serious side effects from midazolam. It is important to be aware of possible reactions and what to do if they happen.

  • Read the package insert for more information.
  • Call your provider's office right away if any of these problems occur.

Heart and breathing problems: These have happened rarely after midazolam has been used. These include:

  • Slowed breathing, blocking of the airway, low oxygen levels, change in breathing patterns, heart attack or respiratory (breathing) arrest. Of note: cardiac or respiratory arrest was not seen during clinical drug trials of midazolam.
  • Rarely, periods of low blood pressure have been seen when midazolam was given for tests, surgery, or in people with other medical problems. Low blood pressure may happen more often in people who have been given a narcotic pain killer at the same time.
  • The risk of breathing problems is greater in older adults, people with other chronic health problems, and people with other breathing problems.

Central nervous system (CNS) depression: Drugs like midazolam can potentially depress or affect the CNS (the brain and spinal cord) causing too much sedation or sleepiness, slowed breathing, coma, or even death. The risk of this is increased if midazolam is used with:

  • Other medications that can depress or affect brain function.
  • Medicines that inhibit or affect how some medicines work can also cause this risk. One group of these medicines is called CYP3A4 Inhibitors – these drugs can increase side effects of midazolam.
  • Alcohol or other substances that can affect the brain. Opioids (a group of medicines used to treat severe pain) can cause severe sedation or sleepiness, slowed breathing, coma, and death if used with midazolam.
    • Before using midazolam, talk to your health care provider about any use of an opioid medicine. Keep close follow-up with your health care team if these medicines are used together.

Allergic reactions: Allergic reactions happen rarely, but can cause symptoms such as low blood pressure, hives, rash, breathing difficulties, and swelling. It can happen after the first dose or any time when taking the medicine. Since this can be life-threatening, if these symptoms occur, get immediate medical help 

Suicidal thoughts and behavior: Since 2008, the Food and Drug Administration (FDA) has placed a warning on seizure medications or antiepileptic drugs (AEDs) used for any reason. The FDA alert states that some AEDs may increase a person’s risk for suicidal thoughts or behavior. Together, these thoughts and behaviors are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, more had symptoms of suicidality than people taking a placebo or inactive substance — 3.5 of 1,000 people taking a seizure medicine had suicidality compared to 1 of 1,000 people taking a placebo.

  • Since nasal midazolam is being used intermittently for cluster seizures, the risk for suicidality would likely be rare.
  • People taking any AED should talk to their provider about the following recommendations:
    • Taking seizure medicines may increase the risk of having suicidal thoughts or actions.
    • Do not make any changes to the medicines without first talking to the prescribing health care provider.
    • Pay close attention to any day-to-day changes in mood, behavior, and actions. These changes can happen very quickly, so it is important to be aware of any sudden differences.
    • Know common warning signs that might be a signal for risk of suicide. Some of these are:
      • Talking or thinking about wanting to hurt yourself or end your life
      • Withdrawing from friends and family
      • Becoming depressed or having your depression get worse
      • Becoming preoccupied with death and dying
      • Giving away prized possessions
    • Contact your health care provider before stopping any seizure medicine. This could possibly lead to worsening of seizure and mood.

Changes in cognitive function: Problems with thinking, memory, or attention are examples of cognitive function. Midazolam has a high risk for causing temporary loss of memory, either partially or completely, for several hours after using this medicine.

  • People should not use dangerous machinery or drive (if they have a valid driver’s license) until the medicine effects have gone away.
  • Children should be watched to make sure they can walk safely alone after using the medicine.

Change in vision – Glaucoma: Medicines like midazolam can raise pressure in an eye in people who have glaucoma.

  • People who have glaucoma should talk to their health care provider and eye doctor before using midazolam. They may need to have eye tests done more often.
  • People who have a form of glaucoma called narrow-angle glaucoma should not use midazolam.

Other potentially serious side effects: When midazolam was used for other reasons, such as sedation, some changes in behavior have been reported, i.e. agitation, involuntary movements or tremors, hyperactivity, and combativeness.

What else is Midazolam Nasal used for?

Midazolam is used alone or with anesthesia before tests or surgery to help people relax, make them sleepy, and not remember the test or surgery.

Who should not take Midazolam Nasal?
  • People who are hypersensitive to midazolam, have had allergic reactions to it, or have acute narrow-angle glaucoma.
  • People who are using opioids or other medications that could interfere with how midazolam works or increase the risk of serious side effects. Midazolam may be used if no other treatments are available — the dose and when to take it may be different.
  • People who have trouble breathing or are too sedated or sleepy after using midazolam. Be aware that sleepiness or breathing troubles can also be related to the seizures.
Can Midazolam Nasal be taken with other medicines?

Use caution when Midazolam is used with:

  • Medicines called CYP3A4 Inhibitors – these can increase the amount of midazolam in the body
    • Examples: erythromycin, diltiazem, verapamil, ketoconazole, itraconazole, clarithromycin
  • Opioids – may increase the risk of respiratory depression or slowed breathing
    • Examples: morphine, hydrocodone, oxymorphone, codeine, fentanyl
  • Other CNS depressants – may increase the risk of breathing problems
    • Examples: other benzodiazepines, barbiturates, other sedatives, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, opioids, alcohol
What are the effects of Midazolam Nasal on Children?

This drug is not approved for use in children under 12 years old. The safety and benefits in children of this age is unknown.

If a woman takes Midazolam Nasal during pregnancy will it hurt the baby?
  • There are no adequate and well-controlled studies of Nayzilam in pregnant women.
  • Babies born to mothers receiving benzodiazepine medicines (including Nayzilam) late in pregnancy may be at risk of having breathing problems, feeding problems, very low body temperature, and withdrawal symptoms.
  • Nayzilam should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the baby.
What are the effects of Midazolam Nasal on Seniors

Midazolam is digested and broken down differently in older adults. The time it takes for the body to eliminate midazolam and its' metabolites is longer too. 

  • The drug may last longer in an older adult than in a younger person.
  • Older adults could potentially have more side effects or be more sensitive to midazolam. 
  • Close monitoring of older adults taking midazolam is recommended.
Read the package insert of Midazolam Nasal

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