Midazolam Intranasal

Midazolam Intranasal is a prescription medication used for the treatment of seizures.

• Midazolam Intranasal is available under the following different brand names: Nayzilam

Adult and pediatric dosage

Intranasal solution: Schedule IV

• 5mg/0.1mL per single-dose spray

Seizures

Adult dosage

• Initial dose: 5 mg (1 spray) into 1 nostril
• Second dose (if needed)
  • An additional 5 mg (1 spray) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose
• Maximum dose and frequency
  • Do not use above 2 doses per single seizure episode
  • Do not treat more than 1 episode every 3 days and no more than 5 episodes/month

Pediatric dosage

• Children below 12 years: Safety and efficacy not established
• Children above 12 years
  • Initial dose: 5 mg (1 spray) into 1 nostril
  • Second dose (if needed)
    • An additional 5 mg (1 spray) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose
• Maximum dose and frequency
  • Do not use above 2 doses per single seizure episode
  • Do not treat more than 1 episode every 3 days and no more than 5 episodes/month

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Midazolam Intranasal include:

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

Serious side effects of Midazolam Intranasal include:

• extreme drowsiness;
• unusual muscle movements, or a seizure;
• sudden mood or behavior changes, hallucinations;
• agitation, anxiety, panic, trouble sleeping, feeling irritable; or
• depression, thoughts about suicide, or self-hurting.

Rare side effects of Midazolam Intranasal include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Midazolam Intranasal has severe interactions with no other drugs.
• Midazolam Intranasal has serious interactions with at least 59 other drugs.
• Midazolam Intranasal has moderate interactions with at least 299 other drugs.
• Midazolam Intranasal has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Known hypersensitivity
• Acute narrow-angle glaucoma

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Midazolam Intranasal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Midazolam Intranasal?”

Cautions

• Serious cardiorespiratory adverse reactions were reported, including respiratory depression, airway obstruction, oxygen desaturation, apnea, respiratory arrest, and/or cardiac arrest, sometimes resulting in death or permanent neurologic injury; the danger of hypoventilation, airway obstruction, or apnea is greater in the elderly patients and those with chronic disease states or decreased pulmonary reserve
• Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication; pooled analyses of 199 placebo-controlled clinical trials of 11 different AEDs showed ~2 x risk of suicidal thinking or behavior in patients taking AEDs; should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms may be related to the illness being treated
• May impair cognitive function; use associated with a high incidence of partial or complete impairment of recall for several hours following a dose
• Benzodiazepines can increase intraocular pressure in patients with glaucoma; may use in patients with open-angle glaucoma who are controlled with medication; contraindicated with narrow-angle glaucoma
• When midazolam was used for sedation, reactions such as agitation, involuntary movements (including tonic/clonic movements and muscle tremor), hyperactivity, and combativeness reported
• Slower elimination and prolonged drug exposure of midazolam and its metabolites observed in patients with renal or hepatic impairment or congestive heart failure
• Use of drugs, particularly in patients at elevated risk of abuse, necessitates counseling about risks and proper use of the drug along with monitoring for signs and symptoms of abuse, misuse, and addiction; do not exceed recommended dosing frequency
• Avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (eg, opioid analgesics, stimulants); advise patients on proper disposal of the unused drug; if a substance use disorder is suspected, evaluate patient and institute (or refer them for) early treatment, as appropriate
• For patients using treated more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue therapy (a patient-specific plan should be used to taper the dose)
• Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages and those who have had longer durations of use
• In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months
• Drug interaction overview
  • Opioids and benzodiazepines: Concomitant use of benzodiazepines (including midazolam Intranasal) and opioids may result in profound sedation, respiratory depression, coma, and death; only use in patients for whom alternative treatment options are inadequate; hypotension more likely if the patient is premedicated with a narcotic
  • CNS depressants: CNS depression reported with coadministration with other CNS depressants (eg, barbiturates, alcohol)
  • CYP3A4 inhibitors: Risk of prolonged sedation if coadministered with moderate or strong CYP3A4 enzyme inhibitors, owing to much higher midazolam exposures
  • CYP3A4 inducers: Midazolam exposure decreased 16-26% if coadministered with strong CYP3A4 inducers and by 8-15% by weak-to-moderate inducers

Pregnancy and Lactation

• There are no adequate and well-controlled studies of midazolam Intranasal in pregnant women
• Available data suggest benzodiazepines are not associated with marked increases in risk for congenital anomalies
• Clinical considerations
  • Exposure to benzodiazepines during the second and third trimesters of pregnancy or immediately before or during childbirth may increase the risk for decreased fetal movement and/or fetal heart rate variability, floppy infant syndrome, dependence, and withdrawal
  • Clinical manifestations of withdrawal or neonatal abstinence syndrome may include hypertonia, hyperreflexia, hypoventilation, irritability, tremors, diarrhea, and vomiting
• Pregnancy registry
  • Encourage women prescribed midazolam Intranasal during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or register at http://www.aedpregnancyregistry.org/
• Lactation
  • Midazolam is excreted in human milk
  • Studies assessing effects in the breastfed infant or on milk production/excretion have not been performed
  • Postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines may experience lethargy, somnolence, and poor sucking