MIDAZOLAM IN 0.9% SODIUM CHLORIDE (midazolam) · Hikma
Midazolam in 0.9% Sodium Chloride Injection is indicated: Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. Midazolam in 0.9% Sodium Chloride Injection is a benzodiazepine indicated for: continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or du...
Details
- Status
- Prescription
- First Approved
- 2021-03-22
- Patent Cliff
- 2038
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
MIDAZOLAM IN 0.9% SODIUM CHLORIDE Approval History
What MIDAZOLAM IN 0.9% SODIUM CHLORIDE Treats
2 indicationsMIDAZOLAM IN 0.9% SODIUM CHLORIDE is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety
- Amnesia
MIDAZOLAM IN 0.9% SODIUM CHLORIDE Boxed Warning
PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS Personnel and Equipment for Monitoring and Resuscitation Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Midazolam in 0.9% Sodium Chloride Injection [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 )]. Administering personn...
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS Personnel and Equipment for Monitoring and Resuscitation Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer Midazolam in 0.9% Sodium Chloride Injection [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 )]. Administering personnel must be trained in the detection and management of airway obstruction, hypoventilation, and apnea, including the maintenance of a patent airway, supportive ventilation, and cardiovascular resuscitation [see Dosage and Administration ( 2.1 ) , Warnings and Precautions ( 5.1 )]. Resuscitative drugs, and age- and size-appropriate equipment for bag/valve/mask assisted ventilation must be immediately available during administration of Midazolam in 0.9% Sodium Chloride Injection [see Dosage and Administration ( 2.1 ) , Warnings and Precautions ( 5.1 )]. Continuously monitor vital signs during sedation and during the recovery period [see Dosage and Administration ( 2.1 ) , Warnings and Precautions ( 5.1 )]. Risks from Concomitant Use with Opioid Analgesics and Other Sedative Hypnotics Concomitant use of benzodiazepines, including Midazolam in 0.9% Sodium Chloride Injection, and opioids may result in profound sedation, respiratory depression, coma, and death. Continuously monitor patients for respiratory depression and depth of sedation [see Warnings and Precautions ( 5.2 ) and Drug Interaction ( 7.1 )] . WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION, AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS See full prescribing information for complete boxed warning. Only personnel trained in the administration of procedural sedation, and not involved in the conduct of the diagnostic or therapeutic procedure, should administer
MIDAZOLAM IN 0.9% SODIUM CHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 MIDAZOLAM IN 0.9% SODIUM CHLORIDE
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
530 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07584434 | VX25-433-001 | Ph 1 | 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 |
| NCT05614739 FORAGER-1 | 18594 J4G-OX-JZVA, 2022-502755-59-00 | Ph 1 | recruiting | FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3 |
| 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 | completed | Drug-Drug Interaction Study of Atumelnant in Healthy Participants |
| NCT06835569 | 3263-001 | Ph 1 | recruiting | A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations |
| NCT05646862 INAVO121 | WO43919 2022-502322-41-00 | Ph 3 | 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 | active not 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 | completed | 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 |
| NCT07020221 | VS-7375-101 | Ph 1, Ph 2 | recruiting | A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors |
| 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 | completed | Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis |
| NCT07525544 | 300109 | Ph 1 | recruiting | A Study to Investigate the Safety and PK of VH4770359 in Healthy Participants |
| NCT07426757 | C6331001 KAT2i | Ph 1 | 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, 2025 | Ph 1 | 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 results posted | 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 | completed | 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 results posted | 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 | completed | 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 | completed | A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin |
| NCT07339722 | 27789 J6V-MC-OIAB | Ph 1 | recruiting | A Study of LY4515100 in Healthy Participants |
| 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 | suspended | A Study to Test How Well Different Doses of BI 3031185 Are Tolerated by Healthy Men and Women |
| 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 |
| NCT06717269 | NX-5948-304 | Ph 1 | completed | A Single and Multiple Ascending Doses, Relative Bioavailability, Food Effect, and Drug-Drug Interaction Study of NX-5948 in Healthy Volunteers |
| NCT05208047 | CGT9486-21-301 | Ph 3 | 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 |
Showing 50 of 530 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.
MIDAZOLAM IN 0.9% SODIUM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Midazolam in 0.9% Sodium Chloride Injection is indicated: Continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. Midazolam in 0.9% Sodium Chloride Injection is a benzodiazepine indicated for: continuous intravenous infusion for sedation of intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting.
WARNING: PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION AND RISKS FROM CONCOMITANT USE WITH OPIOID ANALGESICS AND OTHER SEDATIVE-HYPNOTICS Personnel and Equipment for Monitoring and Resuscitation Only personnel trained in the administration of procedural sedation, and not involved in the c...
MIDAZOLAM IN 0.9% SODIUM CHLORIDE Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 13 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.