NAYZILAM (midazolam)
Nayzilam is a benzodiazepine indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity in patients with epilepsy. These episodes, which include seizure clusters and acute repetitive seizures, are characterized by being distinct from a patient’s usual seizure pattern. The medication is approved for use in adult and pediatric patients 12 years of age and older.
How NAYZILAM Works
Midazolam is thought to work by potentiating GABAergic neurotransmission. This process occurs through the drug binding to the benzodiazepine site of the GABA A receptor. By interacting with this specific biological target, the medication enhances inhibitory signaling to achieve its therapeutic effect.
Details
- Status
- Prescription
- First Approved
- 2019-05-17
- Patent Cliff
- 2028
- Routes
- NASAL
- Dosage Forms
- SPRAY
NAYZILAM Approval History
What NAYZILAM Treats
2 indicationsNAYZILAM is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Epilepsy
- Seizures
NAYZILAM Boxed Warning
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 Pre...
WARNING: 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
NAYZILAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to NAYZILAM
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
503 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07584434 | VX25-433-001 | Ph 1 | not yet recruiting | A Phase 1, First-in-human Study of VX-433 |
| NCT04067336 | KO-MEN-001 | Ph 1, Ph 2 | active not recruiting | First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia |
| NCT07227454 AVENUE | 54135419SUI3003 54135419SUI3003, 2024-518615-19-00 | Ph 3 | recruiting | A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder |
| NCT02365597 results posted | CR105065 42756493BLC2001, 2014-002408-26 | Ph 2 | active not recruiting | An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer |
| NCT07570082 | CRN04894-131 | Ph 1 | recruiting | Drug-Drug Interaction Study of Atumelnant in Healthy Participants |
| NCT05646862 INAVO121 | WO43919 2022-502322-41-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy |
| NCT05355701 | C4761001 BRAF Class 2 | Ph 1 | recruiting | A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations. |
| NCT07567781 | M25-744 | Ph 1 | recruiting | A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults. |
| NCT07556523 | IRB2025-0154 | Ph 4 | recruiting | Patient Quality of Recovery After TAVR With Different Sedation Regimens |
| NCT07154147 CatNAPS-2 | 25-43837 | Ph 4 | completed | Oral vs IV Sedation for Cataract Surgery in Older Adults |
| NCT06686628 | INT18404 U1111-1303-3406, 2024-513495-17 | Ph 1 | completed | An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates |
| NCT07542990 PEDIADEX | PEDIADEX | Ph 3 | not yet recruiting | Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care |
| NCT02166853 SEGA | CHU-0195 2013-005389-21 | Ph 4 | completed | Effects of SEvoflurane on Gas Exchange and Inflammation in Patients With ARDS (SEGA Study) |
| NCT07388511 | BLU-263-0104 | Ph 1 | completed | A Study of Elenestinib in Healthy Adult Female Participants |
| NCT02783040 results posted | 1346.22 2015-001371-41 | Ph 1 | completed | Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin |
| NCT06154447 | VX23-828-001 | Ph 1 | recruiting | Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis |
| NCT07525544 | 300109 | Ph 1 | not yet recruiting | A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants |
| NCT07426757 | C6331001 KAT2i | Ph 1 | not yet recruiting | An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers |
| NCT06692192 | 2024-0852 A538900, SMPH/PSYCHIATRY/PSYCHIATRY | Ph 1 | recruiting | The RECAP2 Study: Midazolam and Psilocybin |
| NCT07340190 | CDAK539A12102 2025-521000-22-00 | Ph 1 | not yet recruiting | A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies |
| NCT06679413 | UP0132 | Ph 1 | completed | A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants |
| NCT05258110 results posted | 1346-0035 2021-005585-17 | Ph 1 | completed | A Study in Healthy Men to Test Whether BI 425809 Influences the Amount of Midazolam in the Blood |
| NCT06964776 | 27387 J6E-MC-KWAC, MORF-057 | Ph 1 | completed | A Study of LY4268989 (MORF-057) in Healthy Participants |
| NCT07435194 | 2828-007 MK-2828-007 | Ph 1 | recruiting | A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007) |
| NCT05378100 INKLING-MS | IRB00322473 | Ph 2 | active not recruiting | Ketamine for Multiple Sclerosis Fatigue |
| NCT07184801 DEMISE-MT | IEC-INT/2025/DM-2480 | Ph 3 | recruiting | Safety and Efficacy of Dexmedetomidate vs. Midazolam for Procedural Sedation During Medical Thoracoscopy |
| NCT06716190 | 1519-0002 2024-517209-95-00, U1111-1313-5393 | Ph 1 | terminated | A Study to Test How Different Doses of BI 3731579 Are Tolerated by Healthy People |
| NCT03600883 | 20170543 | Ph 1, Ph 2 | active not recruiting | A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100) |
| NCT06564441 | 1404-0008 2024-512332-29-00, U1111-1307-0132 | Ph 1 | completed | A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity |
| NCT07443254 | 26-1377 | Ph 1, Ph 2 | recruiting | Prospective IR-led Sedation Feasibility |
| NCT07118215 | CN012-0013 | Ph 1 | recruiting | A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin |
| NCT06979973 | A104_03DDI2501 | Ph 1 | completed | A Drug-drug Interaction Study to Investigate the Pharmacokinetic Interactions Between CKD-508, Midazolam, and Rosuvastatin in Healthy Adult Male Participants |
| NCT07289776 | HP7041-01 | Ph 1 | recruiting | A First-in-human Trial of GRT7041 in Healthy Participants |
| NCT07020988 | UP0127 | Ph 1 | completed | A Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Midazolam and Diazepam in Healthy Participants |
| NCT07235748 | S095032-230 | Ph 1 | completed | Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants |
| NCT06916702 | 1516-0002 2024-516921-29-00, U1111-1311-3555 | Ph 1 | recruiting | A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men |
| NCT04973163 | 1472-0001 2021-000460-29 | Ph 1 | active not recruiting | A Study to Test Different Doses of BI 1823911 Alone and Combined With Other Medicines in People With Different Types of Advanced Cancer With KRAS Mutation |
| NCT06575933 | 1084-009 CA43815, MK-1084-009 | Ph 1 | completed | A Study of Calderasib (MK-1084) With Midazolam and Digoxin in Healthy Participants (MK-1084-009) |
| NCT06878703 DEXPRE | APHP230813 | Ph 3 | recruiting | Efficacy of Dexmedetomidine Versus Midazolam Sedation on Extubation Time in Mechanically Ventilated Preterm Infants |
| NCT05208047 | CGT9486-21-301 | Ph 3 | active not recruiting | (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors |
| NCT07357610 SIM0270-104 | SIM0270-104 | Ph 1 | recruiting | An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants |
| NCT07331389 | HDM1002-111 | Ph 1 | recruiting | A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin |
| NCT05631704 | 218803 | Ph 1 | completed | A Study to Investigate Safety, Tolerability, and Pharmacokinetics (PK) of VH4524184 and the Potential for Changes in Cytochrome P450 3A (CYP3A) Activity |
| NCT07300826 | Dexmedetomidine VS Midazolam | Ph 4 | not yet recruiting | Intravenous Dexmedetomidine Versus Midazolam in Preventing Shivering in Trauma Patients Undergoing Lower Limb Orthopedic Surgery Under Spinal Anesthesia |
| NCT07226635 DDI | SPI-62-CL-1004 | Ph 1 | completed | Pharmacokinetic Interaction Trial of Clofutriben With Midazolam and Prednisolone |
| NCT06417125 | K2024-01-006 | Ph 4 | completed | Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children |
| NCT00577200 MACDrive | ABuv110507 | Ph 4 | active not recruiting | Safety of Driving After Minor Surgery With Monitored Anesthesia Care |
| NCT06689527 results posted | SNT-I-VAM-025 2024-513845-36-00 | Ph 1 | completed | Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics |
| NCT06741930 Ketamin stdy | 35-2024 | Ph 4 | completed | Pro-Epileptic Effects of IV Ketamine |
| NCT04840888 results posted | 18204 J2J-MC-JZLD | Ph 1 | completed | A Study of LY3484356 in Healthy Female Participants |
Showing 50 of 503 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NAYZILAM FDA Label Details
Indications & Usage
FDA Label (PDF)NAYZILAM is indicated for the treatment of Epilepsy; Seizures.
WARNING: 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 patient...
NAYZILAM Patents & Exclusivity
Patents (4 active)
Exclusivity
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Revenue Insights
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Patent Timeline
- • Cliff: 2028
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
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Competitive Landscape
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.