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NERVOUS SYSTEM › PSYCHOLEPTICS › HYPNOTICS AND SEDATIVES › Other hypnotics and sedatives
niaprazine
N05CM16
Forms & Strengths
- Oral syrup: 0.1% (1 mg/mL)
Adult Dosing
- Insomnia: 10 to 20 mg (10 to 20 mL of 0.1% syrup) administered orally 30 minutes before bedtime.
Pediatric Dosing
- Children > 6 months: 1 mg/kg/day administered orally in a single dose at bedtime, or divided into 2 to 3 doses.
Indications
- Short-term management of sleep disorders and insomnia in pediatric and adult patients
- Adjuvant treatment of anxiety symptoms
Mechanism of Action
- Acts primarily as a sedative-hypnotic agent with antihistaminic (H1) and alpha-1 adrenergic antagonist properties
- Exerts central nervous system depressant effects partly through antagonism at serotonergic (5-HT2) receptors
Contraindications
- Hypersensitivity to niaprazine or any excipients in the formulation
- Severe hepatic impairment
- Concurrent use with CNS depressants or alcohol
- History of QT prolongation or significant cardiac arrhythmias
Adverse Reactions
- Drowsiness and somnolence (residual morning sedation)
- Dizziness
- Dry mouth
- Asthenia and fatigue
- Paradoxical excitation in children (rare)
Drug Interactions
- Alcohol and other CNS depressants (opioids, benzodiazepines, barbiturates): potentiation of sedative effects and respiratory depression
- Anticholinergic agents: increased risk of additive anticholinergic adverse effects
- QT-prolonging drugs: potential additive risk of cardiac arrhythmias
Curated Content: Needs Vetting Before Put to Clinical Use