nayzilam
Pharmaranks rates Nayzilam 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Nayzilam (Midazolam) is a benzodiazepine used to treat Anxiety Disorders, Psychomotor Agitation, Status Epilepticus.
Midazolam · by Ucb Inc
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Midazolam
- Drug class
- Benzodiazepine
- Form
- Spray/Inhaler
- Strength
- Midazolam 5MG/SPRAY
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Ucb Inc
- What the pharmacy pays
- ~$0.45 per ml — not your price
- FDA application
- NDA211321
- FDA boxed warning
- Yes — see the boxed warning
What is Nayzilam?
From the FDA label:NAYZILAM contains midazolam, a compound of the benzodiazepine class. Midazolam is chemically designated as 8-Chloro-6-(ο-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine, and it has the following structure: The empirical formula is C 18 H 13 ClFN 3 representing a molecular weight of 325.8. Midazolam, USP is a white or yellowish, crystalline powder that is practically insoluble in water, soluble in methanol, and freely soluble in acetone and in alcohol. NAYZILAM nasal spray is a clear, colorless to yellowish colored liquid. Each single-dose NAYZILAM unit is for nasal administration and delivers 5 mg of midazolam in 0.1 mL of solution containing ethanol; PEG-6 methyl ether; polyethylene glycol 400; propylene glycol; and purified water. The pH range of solution is approximately 5.0 to 9.0. Chemical Structure
How to use
Administer NAYZILAM by the nasal route only. ( 2.2 ) Initial Dose : Administer one spray (5 mg dose) into one nostril. ( 2.2 ) Second Dose : 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. ( 2.2 ) Maximum Dosage and Treatment Frequency: Do not use more than 2 doses of NAYZILAM to treat a seizure cluster. It is recommended that NAYZILAM be used to treat no more than one episode every three days and treat no more than five episodes per month. ( 2.2 ) 2.1 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 [see Warnings and Precautions (5.4) ] . Prior to treatment, the healthcare professional should instruct the individual administering NAYZILAM on how to identify seizure clusters and use the product appropriately [see Patient Counseling Information: Administration Information (17) ] . Patients and caregivers should be counseled to read carefully the "Instructions for Use" for complete directions on how to properly administer NAYZILAM. 2.2 Dosage…
Side effects
The following serious adverse reactions are discussed in more detail in other sections of the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1) ] Abuse, Misuse, and Addiction [see Warnings and Precautions (5.2) ] Dependence and Withdrawal Reactions After Use of NAYZILAM More Frequently Than Recommended [see Warnings and Precautions (5.3) ] Risks of Cardiorespiratory Adverse Reactions [see Warnings and Precautions (5.4) ] CNS Depression from Concomitant Use with Other CNS Depressants or Moderate or Strong CYP3A4 Inhibitors [see Warnings and Precautions (5.5) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.6) ] Impaired Cognitive Function [see Warnings and Precautions (5.7) ] Glaucoma [see Warnings and Precautions (5.8) ] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions (5.9) ] Other Adverse Reactions [see Warnings and Precautions (5.10) ] The most common adverse reactions (≥5% in any NAYZILAM treatment group) were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact UCB, Inc. at 1-844-599-2273 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death . Reserve concomitant prescribing of these drugs for 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 [see Warnings and Precautions (5.1) and Drug Interactions (7.2) ] . The use of benzodiazepines, including NAYZILAM, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing NAYZILAM and throughout treatment, assess each patient's risk for abuse, misuse, and addiction [see Warnings and Precautions (5.2) ]. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although NAYZILAM is indicated only for intermittent use [see Indications and Usage (1) and Dosage and Administration (2) ] , if used more frequently than recommended abrupt discontinuation or rapid dosage reduction of NAYZILAM may precipitate acute withdrawal reactions, which can be life-threatening. For patients using NAYZILAM more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue NAYZILAM [see Warnings and Precautions (5.3) ]. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS See full prescribing information for complete boxed warning. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death ( 5.1 , 7.2 ) The use of benzodiazepines, including NAYZILAM, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing NAYZILAM and throughout treatment, assess each patient's risk for abuse, misuse, and addiction ( 5.2 ). Although NAYZILAM is indicated only for intermittent use ( 1 , 2 ), if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of NAYZILAM may precipitate acute withdrawal reactions, which can be life-threatening. For patients using NAYZILAM more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue NAYZILAM ( 5.3 ).
Warnings
Important safety information
CNS Depression From Concomitant Use With Other CNS Depressants or Moderate or Strong CYP3A4 Inhibitors : May cause an increased CNS-depressant effect when used with alcohol or other CNS depressants. Concomitant use with moderate or strong CYP3A4 inhibitors may result in prolonged sedation because of a decrease in plasma clearance of midazolam. ( 5.5 , 7.3 ) Suicidal Behavior and Ideation: Antiepileptic drugs increase the risk of suicidal ideation and behavior. ( 5.6 ) Impaired Cognitive Function: Midazolam is associated with a high incidence of partial or complete impairment of recall for the next several hours. ( 5.7 ) Glaucoma: NAYZILAM can increase intraocular pressure in patients with glaucoma. Patients with open-angle glaucoma may need to have their ophthalmologic status evaluated following treatment with NAYZILAM. ( 5.8 ) Neonatal Sedation and Withdrawal Syndrome: NAYZILAM use during pregnancy can result in neonatal sedation and/or neonatal withdrawal. ( 5.9 , 8.1 ) 5.1 Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including NAYZILAM, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe NAYZILAM concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when NAYZILAM is used with opioids [see Drug Interactions (7.2) ] . 5.2 Abuse, Misuse, and Addiction The use of benzodiazepines, including NAYZILAM, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death [see Drug Abuse and Dependence (9.2) ] . Before prescribing NAYZILAM and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. Use of NAYZILAM, particularly in patients at elevated risk, necessitates counseling about the risks and proper use of NAYZILAM along with monitoring for signs and symptoms of abuse, misuse, and addiction. Do not exceed the recommended dosing frequency; avoid or minimize concomitant use of CNS depressants and other substances associated with abuse, misuse, and addiction (e.g., opioid analgesics, stimulants); and advise patients on the proper disposal of unused drug. If a substance use disorder is suspected, evaluate the patient and institute (or refer them for) early treatment, as appropriate. 5.3 Dependence and Withdrawal Reactions After Use of NAYZILAM More Frequently Than Recommended For patients using NAYZILAM more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue NAYZILAM (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. Acute Withdrawal Reactions The continued use of benzodiazepines may lead to clinically significant physical dependence. Although NAYZILAM is indicated only for intermittent use [see Indications and Usage (1) and Dosage and Administration (2) ] , if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of NAYZILAM, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see Drug Abuse and Dependence (9.3) ]. Protracted Withdrawal Syndrome In some cases, benzodiazepine users have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months [see Drug Abuse and Dependence (9.3) ] . 5.4 Risks of Cardiorespiratory Adverse Reactions Serious cardiorespiratory adverse reactions have occurred after administration of midazolam. These have included respiratory depression, airway obstruction, oxygen desaturation, apnea, respiratory arrest and/or cardiac arrest, sometimes resulting in death or permanent neurologic injury. There have also been rare reports of hypotensive episodes requiring treatment during or after diagnostic or surgical manipulations, particularly in patients with hemodynamic instability. Hypotension occurs more frequently in patients premedicated with a narcotic. The danger of hypoventilation, airway obstruction, or apnea is greater in elderly patients and those with chronic disease states or decreased pulmonary reserve [see Use in Specific Populations (8.5) ] ; patients with chronic obstructive pulmonary disease are highly sensitive to the respiratory depressant effect of midazolam. Respiratory depression was observed with the administration of NAYZILAM during clinical trials [see Adverse Reactions (6.1) ] . Cardiac or respiratory arrest caused by NAYZILAM was not reported during clinical trials. 5.5 Central Nervous System Depression from Concomitant Use with Other Central Nervous System Depressants, or Moderate or Strong CYP3A4 Inhibitors Drug products containing midazolam, including NAYZILAM, have a central nervous system (CNS) depressant effect. Risks from Concomitant Use with Other CNS Depressants The potential for an increased CNS-depressant effect from concomitant use with alcohol or other CNS depressants (e.g., opioids) must be considered by the prescribing physician, and appropriate recommendations made to the patient and/or caregiver [see Warnings and Precautions (5.1) and Drug Abuse and Dependence (9.3) ] . 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 [see Drug Interactions (7.3) ]. Risks from Concomitant Use with Moderate or Strong CYP3A4 Inhibitors There is a potential for prolonged sedation from concomitant use with moderate or strong CYP3A4 enzyme inhibitors because of much higher midazolam exposures [see Drug Interactions (7.2) and Clinical Pharmacology (12.2) ]. 5.6 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including NAYZILAM, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared to 0.24% among 16,029 placebo-treated patients, representing an increase of approximately one case of suicidal thinking or behavior for every 530 patients treated. There were four suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug…
Who should not take Nayzilam
NAYZILAM is contraindicated in patients with: Known hypersensitivity to midazolam. Acute narrow-angle glaucoma [see Warnings and Precautions (5.8) ]. Patients with hypersensitivity to midazolam ( 4 ) Patients with acute narrow-angle glaucoma ( 4 )
Overdose — what happens if you take too much
Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal [see Warnings and Precautions (5.2) ] . Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway maintenance. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures, particularly in the context of mixed overdosage with drugs that increase seizure risk (e.g., tricyclic and tetracyclic antidepressants) and in…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Table 3: Clinically Significant Drug Interactions With NAYZILAM 7.1 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 7.2 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 GABA A 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 [see Warnings and Precautions (5.1) ]. Examples: Morphine, hydrocodone, oxymorphone, codeine, fentanyl 7.3 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 [see Warnings and Precautions (5.5) ] . Examples: Other benzodiazepines and sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, opioids, alcohol. CYP3A4 Inhibitors : Avoid co-administration of NAYZILAM with moderate or strong CYP3A4 inhibitors. NAYZILAM should be used with caution when co-administered with mild CYP3A4 inhibitors. ( 7.1 ) Opioids : Risk of respiratory depression is increased. ( 7.2 ) Other CNS Depressants : May increase the risks of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect. ( 7.3 )
Drug class
How this class works, per Benzodiazepines — StatPearls, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
See how Nayzilam ranks — best-rated benzodiazepine for:
Dosage forms
Spray/Inhaler
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Nayzilam treat?
- Nayzilam (Midazolam) may be used to treat anxiety disorders, psychomotor agitation, status epilepticus, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Nayzilam work?
- Nayzilam is a benzodiazepine. Benzodiazepines boost the brain's main calming chemical, GABA, by binding to the GABA-A receptor and making its chloride channel open more often. This quiets nerve activity, producing sedation, reduced anxiety, muscle relaxation, and protection against seizures.
- How is Nayzilam rated?
- pharmaranks gives Nayzilam a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Nayzilam cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.45 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Nayzilam?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Nayzilam. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Nayzilam?
- Nayzilam is marketed by Ucb Inc. You can see Ucb Inc's full profile, rating, and other products on pharmaranks.
- Is Nayzilam a brand-name or generic drug?
- Nayzilam is a brand-name product with the active ingredient Midazolam.
- Is Nayzilam available over the counter?
- No. Nayzilam is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Nayzilam come in?
- Nayzilam is currently marketed as spray/inhaler, per the FDA's National Drug Code Directory.
- What class of drug is Nayzilam?
- Nayzilam is classified as benzodiazepine, per the FDA's Established Pharmacologic Class.
- Is Nayzilam FDA-registered?
- Nayzilam is on record with the U.S. FDA under application number NDA211321. You can verify this on its official FDA label.
- Has Nayzilam been recalled by the FDA?
- Nayzilam has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Nayzilam safe?
- There's no single safe-or-not verdict. pharmaranks gives Nayzilam a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Nayzilam?
- Nayzilam's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are discussed in more detail in other sections of the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1) ] Abuse, Misuse,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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70/100