Nayzilam

Approved Uses

Nayzilam is used for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, which are often called seizure clusters or acute repetitive seizures. These episodes are typically different from a person's usual seizure pattern.

This medication is approved for use in the following groups:

• Adults with epilepsy.
• Children 12 years of age and older with epilepsy.

Nayzilam is intended as a rescue medication to be used when a seizure cluster occurs. It is designed to be administered by a caregiver to help stop the seizures quickly. It is not meant to be used as a daily preventive treatment for epilepsy.

Mechanism of Action

Nayzilam belongs to a class of drugs called benzodiazepines. While the exact way it works is not fully understood, it is believed to help stop seizures by increasing the activity of certain natural chemicals in the brain.

The medication works by:

• Enhancing GABA: It boosts the effects of gamma-aminobutyric acid (GABA), a chemical messenger that sends calming signals throughout the central nervous system.
• Reducing Brain Activity: By increasing GABA activity, the drug helps slow down the intense electrical signals in the brain that lead to seizure clusters.

Because Nayzilam is a nasal spray, it is absorbed through the tissues in the nose. This allows the medicine to enter the bloodstream and reach the brain quickly during an emergency situation.

Common Side Effects

The most common side effects reported with this medication include:

• Sleepiness or drowsiness
• Headache
• Nasal discomfort or runny nose
• Throat irritation
• Coughing

Serious Side Effects

Contact a healthcare provider immediately or seek emergency medical care if you experience any of the following serious symptoms:

• Slow, shallow, or stopped breathing
• Severe drowsiness or difficulty waking up
• Mental or mood changes, such as agitation, confusion, or hallucinations
• New or worsening thoughts of suicide or self-harm
• Signs of an allergic reaction, such as hives, swelling of the face, lips, or throat, and difficulty breathing

Boxed Warnings

Risks from Concomitant Use with Opioids: Using Nayzilam with opioid medications may result in profound sedation, respiratory depression, coma, and death. Combined use should be limited to patients for whom alternative treatment options are inadequate.

Abuse, Misuse, and Addiction: The use of benzodiazepines, including midazolam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing, healthcare providers assess each patient's risk.

Physical Dependence and Withdrawal Reactions: Continued use of benzodiazepines may lead to clinically significant physical dependence. Abruptly stopping or reducing the dosage rapidly can result in life-threatening withdrawal reactions, such as seizures.

Contraindications

Nayzilam should not be used by individuals with:

• Acute narrow-angle glaucoma.
• A known hypersensitivity to midazolam.

Respiratory and Central Nervous System Depression

Nayzilam can cause serious breathing problems, including slowed breathing (respiratory depression) or temporary stopping of breathing (apnea). It also causes central nervous system (CNS) depression, which may impair physical and mental abilities. Patients should avoid driving or operating heavy machinery until the effects of the medication have completely worn off.

Suicidal Behavior and Ideation

Antiepileptic drugs, including those used for seizure clusters, may increase the risk of suicidal thoughts or behavior. Patients and caregivers should monitor for any new or worsening depression, unusual changes in mood, or suicidal thoughts.

Paradoxical Reactions

In some cases, midazolam may cause reactions opposite to the intended effect, such as agitation, involuntary movements, hyperactivity, or combativeness. If these symptoms occur, medical attention may be necessary.

Pregnancy

There is limited information regarding the use of Nayzilam in pregnant individuals. However, midazolam belongs to a class of drugs called benzodiazepines, which may cause harm to a developing fetus. If used during the later stages of pregnancy, there is a risk that the newborn may experience breathing problems, feeding difficulties, or excessive sleepiness.

Regular use of benzodiazepines during pregnancy can also lead to physical dependence in the infant, resulting in withdrawal symptoms after birth. If you are pregnant or planning to become pregnant, it is important to talk to your doctor about the risks of using this medication and whether there is a need to enroll in a pregnancy registry to monitor outcomes.

Breastfeeding

Midazolam passes into breast milk in small amounts. Because it can cause sedation, infants exposed to the drug through breast milk should be monitored for signs of central nervous system depression, including:

• Increased sleepiness
• Difficulty feeding
• Poor weight gain
• Breathing problems

Healthcare providers typically recommend weighing the benefits of breastfeeding against the potential risks to the infant before using this medication while nursing.

Available Forms

Nayzilam is available as a nasal spray. It is supplied in single-use, disposable spray devices. Each device is designed to deliver the medication into a nostril.

The devices are individually packaged in blister packs to ensure they remain ready for use during a seizure emergency.

FDA Approval and Indications

Nayzilam (midazolam) is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, also known as seizure clusters or acute repetitive seizures. It is intended for patients with epilepsy who are 12 years of age or older and whose seizure patterns are distinct from their usual seizure activity.

Boxed Warning

The FDA requires a boxed warning for Nayzilam and all other benzodiazepines due to several significant safety risks:

• Risks from Concomitant Use with Opioids: Using benzodiazepines alongside opioid medications can result in profound sedation, respiratory depression, coma, and death.
• Abuse, Misuse, and Addiction: The use of benzodiazepines, even as prescribed, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death.
• Physical Dependence and Withdrawal Reactions: Long-term use can lead to physical dependence. Stopping the medication suddenly or reducing the dose too quickly can cause life-threatening withdrawal symptoms.

Regulatory Classification

Nayzilam is classified as a Schedule IV controlled substance under the Controlled Substances Act. This classification is due to its potential for abuse, misuse, and the risk of developing physical or psychological dependence.

Safety Communications

In recent years, the FDA has updated the labeling requirements for the entire benzodiazepine class. These updates were mandated to provide more comprehensive information regarding the risks of addiction and the dangers of combining these drugs with other central nervous system depressants.

Insurance and Pharmacy Factors

The amount you pay for Nayzilam is largely determined by your health insurance plan. Insurance companies often place brand-name drugs like Nayzilam into different cost tiers, which affects your copayment or coinsurance responsibility.

Pharmacy prices can also vary. It is often helpful to compare prices at different local pharmacies or through mail-order options provided by your insurance company.

Brand-Name Status

Nayzilam is a brand-name version of midazolam nasal spray. Generic medications are typically less expensive than brand-name ones; however, generic versions of this specific nasal spray formulation may not be available. You should consult with your healthcare provider or pharmacist to discuss the most cost-effective options for your treatment.