Nayzilam (midazolam) Seizure Medications Dosage & Warnings

Generic drug: midazolam

Brand name: Nayzilam

What is Nayzilam (midazolam), and how does it work?

• Nayzilam (midazolam) 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 Nayzilam in a safe place to prevent misuse and abuse. Selling or giving away Nayzilam 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.

What are the side effects of Nayzilam?

WARNING

RISKS FROM CONCOMITANT USE WITH OPIOIDS

Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.

• Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
• Limit dosages and durations to the minimum required.
• Follow patients for signs and symptoms of respiratory depression and sedation.

Nayzilam may cause serious side effects, including:

• Impaired mental alertness including memory problems.
• Increase in eye pressure in people with acute narrow-angle glaucoma.
• See prescribing information for more on serious side effects of:
  • interaction with other central nervous system depressants
  • serious breathing problems and excessive sleepiness
  • suicidal thoughts or actions

The most common side effects of Nayzilam include:

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

These are not all the possible side effects of Nayzilam. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Nayzilam?

Instructions Prior To Dosing

Nayzilam prescribers should consider the following prior to initiation of treatment:

• For patients at increased risk of respiratory depression from benzodiazepines, administration of
  Nayzilam under healthcare professional supervision should be considered prior to treatment with
  Nayzilam; this administration may be performed in the absence of a seizure
  episode.
• Prior to treatment, the healthcare professional should instruct the individual administering
  Nayzilam on how to identify seizure clusters and use the product
  appropriately. Patients and caregivers should be counseled to read carefully the “Instructions for Use”
  information in the prescribing information for complete directions on how to properly administer
  Nayzilam.

Dosage Information

• Administer Nayzilam by the nasal route only.

Initial Dose

• Administer one spray (5 mg dose) into one nostril.

Second Dose (if needed)

• One additional spray (5 mg dose) into the opposite nostril may be administered after 10 minutes if the patient has not responded to the initial dose.
• A second dose of Nayzilam should not be administered if the patient has
  trouble breathing or if there is excessive sedation that is uncharacteristic
  of the patient during a seizure cluster episode.

Maximum Dosage And Treatment Frequency

• Do not use more than 2 doses of Nayzilam to treat a single episode. It is recommended that
  Nayzilam be used to treat no more than one episode every three days and no
  more than 5 episodes per month.

What drugs interact with Nayzilam?

Table 3: Clinically Significant Drug Interactions With
Nayzilam

CYP3A4 Inhibitors

Clinical Impact:
Concomitant use of CYP3A4 inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam.

Intervention:
Avoid co-administration of
Nayzilam with moderate or strong CYP3A4 inhibitors. Nayzilam should be used with caution when co-administered with mild CYP3A4 inhibitors.

Examples:
Moderate CYP3A4 inhibitors: erythromycin, diltiazem, verapamil Strong CYP3A4 inhibitors: ketoconazole, itraconazole, clarithromycin

Opioids

Clinical Impact:
The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABAa sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.

Intervention:
Reserve concomitant prescribing of these drugs for use in patients for whom
alternative treatment options are inadequate. Limit dosages and durations to
the minimum required.

Examples:
Morphine, hydrocodone, oxymorphone, codeine, fentanyl

Other Central Nervous System (CNS) Depressants

Clinical Impact:
Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

Intervention:
Reserve concomitant prescribing of these drugs for use in patients for whom
alternative treatment options are inadequate. Limit dosages and durations to
the minimum required.

Examples:
Other benzodiazepines and sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, opioids, alcohol.

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Does Nayzilam cause addiction or withdrawal symptoms?

Drug Abuse And Dependence

Controlled Substance

• Nayzilam contains the benzodiazepine midazolam, a Schedule IV controlled substance under the Controlled Substances Act.

Abuse

• Benzodiazepines, such as midazolam, may be subject to abuse. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam.
• The pharmacological profile of Nayzilam is similar to that of other benzodiazepines listed in Schedule IV of the Controlled Substance Act, particularly in its potentiation of GABAergic transmission through its action on GABA_A receptors, which leads to sedation and somnolence.
• Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. Midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration.
• Assessment of the abuse-related subjective effects comparing Nayzilam to oral midazolam syrup was conducted in adult subjects with a history of benzodiazepine recreational drug use. No statistically significant or clinically-relevant differences in subjective positive effects (i.e., Drug Liking, Overall Drug Liking, Take Drug Again, and High) were observed between
  Nayzilam and oral midazolam syrup.
• However, subjective positive effects on all these measures were significantly greater for
  Nayzilam than for placebo confirming that Nayzilam has abuse potential. Somnolence occurred at a similar rate in both midazolam groups, but euphoric mood occurred at a greater rate in
  Nayzilam (4 to 16%) compared to the oral midazolam syrup (4 to 8.5%).

Dependence

• Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood levels of the drug, and/or administration of an antagonist.
• Benzodiazepines can cause physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Withdrawal symptoms (i.e., convulsions, hallucinations, tremors, abdominal and muscle cramps, vomiting, and sweating), similar in characteristics to those noted with barbiturates and alcohol, have occurred following abrupt discontinuation of midazolam following chronic administration.

Chronic Use

• Nayzilam is not recommended for chronic, daily use as an anticonvulsant because of the potential for development of tolerance to midazolam. In clinical trials, patients were treated with
  Nayzilam no more frequently than every 3 days.
• Chronic daily use of benzodiazepines may increase the frequency and/or severity of tonic-clonic seizures, requiring an increase in the dosage of standard anticonvulsant medication.
• In such cases, abrupt withdrawal of chronic benzodiazepines may also be associated with a temporary increase in the frequency and/or severity of seizures.

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Is Nayzilam safe to use while pregnant or breastfeeding?

• There are no adequate and well-controlled studies of Nayzilam in pregnant women.
• Available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies.
• Although some early epidemiological studies suggested a relationship between benzodiazepine drug use in pregnancy and congenital anomalies such as cleft lip and or palate, these studies had considerable limitations.
• More recently completed studies of benzodiazepine use in pregnancy have not consistently documented elevated risks for specific congenital anomalies.
• There is insufficient evidence to assess the effect of exposure to benzodiazepines during pregnancy on neurodevelopment.