Melatonin

Active substance
Melatonin
Domain
Neurological disorders
Reason of inclusion in Horizonscan Geneesmiddelen
New medicine (specialité)
Main indication
Sleep disorders
Extended indication
Slenyto is indicated for the treatment of insomnia in children and adolescents aged 2-18 with autism spectrum disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

1. Product

Proprietary name
Slenyto
Manufacturer
Neurim
Mechanism of action
Hormonal therapy
Route of administration
Oral
Therapeutical formulation
Tablet
Budgetting framework
Extramural (GVS)

2. Registration

Registration route
Centralised (EMA)
Type of trajectory
Normal trajectory
Particularity
New therapeutical formulation
Submission date
June 2017
Expected Registration
September 2018
Orphan drug
No
Registration phase
Registered
Additional comments
Betreft een nieuwe formulering. Positieve CHMP-opinie juli 2018. Geregistreerd in september 2018.

3. Therapeutic value

Therapeutic value
No judgement
Substantiation
Het is nog onduidelijk wat er nieuw is aan de formulering van dit middel en wat de directe vergelijkende behandeling is. Om die reden lastig in te schatten wat de therapeutische waarde is van dit geneesmiddel bij de desbetreffende indicatie.
Duration of treatment
Not found
Frequency of administration
1 times a day
Dosage per administration
0,5 mg tot 3 mg
References
Farmacotherapuetisch Kompas; Sánchez-Barceló et al. Int J Pediatr. 2011;2011:892624

4. Expected patient volume per year

There is currently nothing known about the expected patient volume.

5. Expected cost per patient per year

Cost
100 - 200
References
Medicijnkosten.nl.
Additional comments
Verwachting is dat het meerkosten gaat opleveren. Schatting kosten per patiënt per jaar: huidige kosten melatonin.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

Off label use
Yes
Indications off label use
Kinderen met andere slaap problemen.

8. Indication extension

Indication extension
Yes
Indication extensions
Kinderen met andere slaapproblemen
References
Clinicaltrials.gov.

9. Other information

There is currently no futher information available.