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Midazolam: uses, dosing, side effects & brands

Midazolam is a benzodiazepine sold in the U.S. under 4 brand and generic names, for anxiety disorders, psychomotor agitation and status epilepticus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class
Benzodiazepine
Treats (across its forms)
Anxiety Disorders, Psychomotor Agitation and Status Epilepticus
Available as
Spray/Inhaler · Injectable · Syrup · Solution
Sold as
4 products — Nayzilam, Midazolam Hydrochloride and Seizalam, and others
Prescription?
Prescription only
Generic available?
Yes
What the pharmacy pays
about $0.45 per ml — not your price
Boxed warning
Boxed warning

How Nayzilam is dosed

From the FDA label for Nayzilam (application NDA211321). Other midazolam products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

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…

Everything below is the FDA label for Nayzilam (spray/inhaler). Midazolam is also sold as injectable, syrup and solution, and those are different medicines to take — follow the label for the one you were prescribed.

Nayzilam 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…

Who shouldn’t 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 )

Nayzilam drug 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 )

Every midazolam product we track (4)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Midazolam products
#DrugRatingPharmacy pays
170/100$0View →
264/100$0View →
3Not yet rated$0View →
4Not yet rated$0View →

How long midazolam keeps

No midazolam label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does midazolam expire? The in-use limits and storage rules from its labels

Midazolam and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

The small amounts of midazolam excreted into breastmilk would not be expected to cause adverse effects in most breastfed infants. A safety scoring system finds midazolam acceptable to use during breastfeeding. Two expert panels advocates waiting for at least 4 hours after a single intravenous dose of midazolam (e.g., for endoscopy) before resuming nursing. With a newborn or preterm infant a cautious approach would be to wait a period of 6 to 8 hours before resuming nursing. After general anesthesia, breastfeeding can resume as soon as the mother has recovered sufficiently from general anesthesia to nurse. When a combination of anesthetic agents is used for a procedure, follow the recommendations for the most problematic medication used during the procedure. With prolonged use (days) of intravenous therapy, an active metabolite can accumulate in the mother and might affect the infant, but data in breastfeeding are lacking. Monitor the infant for sedation, poor feeding and poor weight gain.

Full LactMed record for midazolam: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised July 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about midazolam

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 31,438 reports naming midazolam, and the FDA flagged 93% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • hypotension1,965 reports
  • seizure1,227 reports
  • pyrexia1,104 reports
  • acute kidney injury958 reports
  • nausea830 reports
  • tachycardia823 reports
  • respiratory failure821 reports
  • renal failure761 reports

Read these as a signal, not a rate. A report does not mean midazolam caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved August 25, 2026.

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Frequently asked questions

What is Nayzilam?

Nayzilam (Midazolam) is a benzodiazepine used to treat Anxiety Disorders, Psychomotor Agitation, Status Epilepticus.

What kind of drug is midazolam?

The FDA classifies midazolam as 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. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take midazolam with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run midazolam against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is midazolam sold under?

We track 4 midazolam-containing products in the U.S.: Nayzilam, Midazolam Hydrochloride, Seizalam and Versed. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does midazolam come in?

Across the brands we track, midazolam is currently marketed as spray/inhaler, injectable, syrup and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic midazolam?

Yes. Our catalog lists 1 generic midazolam product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

How long does midazolam (Versed) stay in your system?

Midazolam is very short-acting. Its elimination half-life is about 1.8–6.4 hours, mean roughly 3 hours (FDA label), so it clears quickly—usually within a day after a single procedural dose. In urine, midazolam and its main metabolite (alpha-hydroxymidazolam, mostly as a glucuronide) are typically detectable for about 1–2 days, and in blood only for several hours. Prolonged infusions (as in ICU sedation), older age, obesity, and liver impairment can extend clearance well beyond these figures. Windows are approximate and vary by individual; this is not medical or legal advice.

Does midazolam reliably show up on a standard benzodiazepine test?

Not always. Although midazolam is a benzodiazepine, it and its metabolites often cross-react poorly with standard benzodiazepine urine immunoassays, so a routine screen can be falsely negative even after recent use. Reliable detection generally requires a specific confirmatory method (LC-MS/MS) targeting midazolam and alpha-hydroxymidazolam. If you received midazolam for a procedure and face a drug test, tell the lab or medical review officer. This is general toxicology information, not medical or legal advice.

Cite this page
APA
pharmaranks. (2026, July 24). Midazolam: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/midazolam
MLA
“Midazolam: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/midazolam.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for midazolam on DailyMed (NIH) ↗ — including its boxed warning in full.