JPWO2021058810A5 - - Google Patents

Claims (15)

Trazodone or a salt thereof is used to treat insomnia in a pediatric population with intellectual or neurodevelopmental disorders (NDD), administered at a dose of 0.2-0.6 mg/kg patient; A pharmaceutical composition comprising trazodone or a salt thereof. 2. The pharmaceutical composition of Claim 1, wherein the NDD is selected from the group comprising autism spectrum disorder (ASD), intellectual disability and attention deficit hyperactivity disorder (ADHD). 3. The pharmaceutical composition according to claim 1 or 2, wherein trazodone or a salt thereof is used to be administered once daily . A pharmaceutical composition according to any one of claims 1 to 3, wherein the trazodone or a salt thereof is used to be administered before bedtime . Trazodone or a salt thereof is a first generation antipsychotic, preferably haloperidol, a second generation antipsychotic, preferably olanzapine, an antidepressant, preferably amitriptyline, a benzodiazepine, preferably lorazepam, an antiepileptic, preferably gabapentin, used co-administered with at least one drug selected from the group consisting of a mood stabilizer, preferably lithium, a psychostimulant, preferably methylphenidate, an anticonvulsant, preferably biperiden and atomoxetine; The pharmaceutical composition according to any one of items 1 to 4. A liquid pediatric pharmaceutical composition comprising trazodone in an amount of 0.1-4% w/v, water and a pediatric acceptable excipient, wherein said pediatric acceptable excipient comprises A liquid pediatric pharmaceutical composition that provides a maximum daily intake (MDI) that is lower than the ADI (acceptable daily intake). Trazodone has a concentration of 1% w/V to 3% w/V for use in a method of treating insomnia in a pediatric population suffering from an intellectual or neurodevelopmental disorder and diluted dropwise in a suitable liquid. 7. The pharmaceutical composition according to claim 6, which provides a dose of 0.2-0.6 mg/kg by. The following excipients: propylene glycol 20-40% w/V, preferably 25-35% w/V, PEG, preferably PEG-400 20-30% w/V, propyl gallate as antioxidant and 8. Pharmaceutical composition according to claim 7, comprising citric acid as a buffering agent. A pharmaceutical composition according to any one of claims 6 to 8, wherein said dose is provided by a number of drops consisting of 5 to 30 drops of either 1.5% or 3% w/V trazodone formulation. 7. A pharmaceutical composition according to claim 6 in syrup form containing trazodone or a salt thereof at a concentration of 0.1-0.9% w/V. The pharmaceutical composition according to claim 10, wherein the trazodone concentration is 0.18-0.3% w/V. Pharmaceutical composition according to any one of claims 10-11, further comprising the following excipients: PEG 0-5% w/V, preferably PEG400 2-4% w/V, glycerol 20-30 % w/V, preferably 23-28% w/V, propylene glycol 5-10% w/V, preferably 6-8% w/V, and sucrose 30-40% w/V, preferably 33-38 %w/V. 13. The pharmaceutical composition according to any one of claims 10-12, wherein 0 trazodone or a salt thereof is used for treating insomnia in a pediatric population suffering from intellectual disability or neurodevelopmental disorder (NDD). A pharmaceutical composition used to be administered at a dose of 2-0.6 mg/kg. A pharmaceutical composition according to any one of claims 1 to 13 for treating insomnia in pediatric patients suffering from neurodevelopmental disorders (NDD). The pharmaceutical composition according to any one of claims 1-14, which is used for chronic administration .