Last reviewed · How we verify
Niravam
At a glance
| Generic name | Niravam |
|---|---|
| Also known as | Alprazolam |
| Sponsor | UCB Pharma |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Common side effects
- Drowsiness
- Lightheadedness
- Sedation
- Concentration difficulties
- Irritability
- Fatigue
- Slurred speech
- Loss of coordination
- Transient amnesia or memory impairment
- Anorexia
- Musculoskeletal weakness
- Pruritus
Serious adverse events
- Seizures
- Hallucinations
- Depersonalization
- Dystonia
- Jaundice
- Elevated hepatic enzymes
- Elevated bilirubin
- Diplopia
- Dysarthria
- Withdrawal seizures
Key clinical trials
- An Open Label, Single Dose, Randomized, Active Comparator, Quantitative Electroencephalogram Crossover Study to Assess the Time to Onset of Action of Staccato Alprazolam Versus Intravenous Midazolam a (Phase 1)
- An Open-Label, Multicenter, Outpatient Extension Study to Evaluate the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizu (Phase 3)
- Randomized, Double-blind, Placebo-controlled Study of a Benzodiazepine vs Placebo on Functional Magnetic Resonance Imaging (fMRI) of the Brain, and on Behavioral/Clinical Measures in Patients With Gen (Phase 4)
- Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2 (NA)
- Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis (Phase 4)
- Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Trial With Single Dosageof Two Oral Preparations Containing 2 mg of Alprazolam (Zamoprax GlaxoSmithKline México, S.A. de C.V. v (Phase 1)
- MELA Study - Hedonic Study on the Taste of Drugs Crushed in Food: Observational Study Involving 16 Healthy Volunteers (Phase 1)
- NCT01546896 (Phase 4)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |