DIASTAT ACUDIAL (diazepam)
Diastat Acudial (diazepam rectal gel) is a benzodiazepine indicated for the management of pediatric and adult patients (2 years and older) with epilepsy, on stable regimens of antiepileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity. This is typically defined as acute repetitive seizures or cluster seizures that are distinct from the patient’s usual seizure pattern.
How DIASTAT ACUDIAL Works
Diazepam is a benzodiazepine that exerts its effects by enhancing the activity of gamma-aminobutyric acid (GABA), the primary inhibitory neurotransmitter in the central nervous system. It binds to specific benzodiazepine receptors on the GABA-A receptor complex, increasing the frequency of chloride channel opening. This results in an influx of chloride ions, leading to hyperpolarization of the neuronal membrane and a subsequent reduction in
Details
- Status
- Prescription
- First Approved
- 1997-07-29
- Routes
- RECTAL
- Dosage Forms
- GEL
DIASTAT ACUDIAL Approval History
What DIASTAT ACUDIAL Treats
7 indicationsDIASTAT ACUDIAL is approved for 7 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Anxiety Disorder
- Alcohol Withdrawal
- Muscle Spasm
- Spasticity
- Athetosis
- Stiff-Man Syndrome
- Seizures
DIASTAT ACUDIAL 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 in 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 in 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 ). • The use of benzodiazepines, including diazepam tablets, 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 diazepam tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS ) . • The continued use of benzodiazepines, including diazepam tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of diazepam tablets after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue diazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS ) .
DIASTAT ACUDIAL 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 DIASTAT ACUDIAL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03818932 results posted | 123192 | Ph 2, Ph 3 | completed | Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction |
| 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 |
| NCT05361447 | 21-007195 | Ph 1, Ph 2 | withdrawn | Diazepam Trial in GAD65 Associated Epilepsy |
| NCT06103188 results posted | M001 | Ph 3 | completed | Comparing the Effect of Melatonin, Diazepam, and Placebo on Decreasing the Level of Anxiety Preoperatively |
| NCT01938092 results posted | 1208827 | Ph 2 | completed | Vaginal Diazepam for the Treatment of Female Pelvic Pain |
| NCT03818919 results posted | 123191 | Ph 2 | completed | Nonopioid Analgesia After Rotator Cuff Repair |
| NCT02904265 results posted | 16-002442 | Ph 2, Ph 3 | terminated | Efficacy Study of Acetazolamide Versus Diazepam in Continuous Spike and Wave/Landau-Kleffner Syndrome |
| NCT01364558 results posted | 1012M93599 | Ph 1 | completed | A Study of Diazepam After Intranasal and Intravenous Administration to Healthy Volunteers |
| NCT02494180 results posted | KW/FR-15-021(83-22) | Ph 4 | completed | A Non-inferiority Trial on Pain Relief During Oocyte Retrieval |
| NCT03825809 | 1231914 | Ph 2, Ph 3 | recruiting | Nonopioid Analgesia After Labral Surgery |
| NCT02646124 results posted | 2015-4639 | Ph 2, Ph 3 | completed | Diazepam Use With Standard Management for Acute Low Back Pain |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01417078 results posted | DZNS-ARS-103 | Ph 2 | completed | A Pharmacokinetic Study of a Single-Dose of Diazepam Nasal Spray in Adult Epileptic Patients Experiencing a Seizure Episode |
| NCT02935972 | Diazepam and TRUS Biopsy | Ph 2, Ph 3 | completed | Combined Intravenous Diazepam, Local Periprostatic Nerve Block for Prostate Biopsy |
| NCT01438749 | BP25259 | Ph 1 | completed | A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users |
| NCT01675648 | Lofex00428 | Ph 4 | completed | Lofexidine for Inpatient Opiate Detox in Singapore |
| NCT01939093 MAP | NRCT-53069 | Ph 4 | completed | Therapeutic Effect of Quetiapine on Methamphetamine-Induced Psychosis |
| NCT01318369 Delta-pain | HEEL-2011-01 | Ph 2 | completed | Efficacy Study of Δ9-THC to Treat Chronic Abdominal Pain |
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.
DIASTAT ACUDIAL FDA Label Details
Indications & Usage
FDA Label (PDF)DIASTAT ACUDIAL is indicated for the treatment of Anxiety Disorder; Alcohol Withdrawal; Muscle Spasm; Spasticity; Athetosis; Stiff-Man Syndrome; 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 in patient...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.