Melatonin is a naturally occurring hormone produced by the pineal gland. Melatonin works by controlling the circadian rhythm and is used to improve sleep quality.
Who is melatonin funded for?
Melatonin (brand name ‘Circadin’) will be funded from 1 July 2017 for children and young people up to the age of 18 years who have neurodevelopment disorders that make it difficult to sleep.
This is an “off-label” use which means that use is not registered with Medsafe (the part of the Ministry of Health that regulates medicines in New Zealand).
For more information on “off-label” use see the BPACnz article: Unapproved medicines and unapproved uses of medicines: keeping prescribers and patients safe.(external link)
How is melatonin funded?
Melatonin is funded via a Special Authority and the person taking the melatonin must meet the Special Authority criteria to get funding.
The Special Authority allows melatonin to be funded for children and young people up to the age of 18 years who have neurodevelopment disorders that make it difficult for them to sleep.
The Special Authority must be applied for by a specialist, or a general practitioner on the recommendation of a specialist.
The specialists who can apply for a Special Authority are psychiatrists, pediatricians, neurologists or respiratory specialists, and the approval will last for one year so will need to be reapplied for each year.
You can find full details of the Special Authority criteria on the PHARMAC notification.
Several Special Authorities have been approved via the Electronic Special Authority system for melatonin for people who don't meet the criteria because they are older than 18 years. We are working with the Ministry of Health to cancel these Special Authority approvals.
What does this mean for:
People whose Special Authority has been cancelled will need to talk to their prescriber.
Prescribers who have applied for melatonin Special Authorities where the patient does not meet the age requirements will be advised by Ministry of Health Sector Operations of the cancellations.
- Prescriptions that have already been dispensed: Pharmacies will be re-reimbursed for melatonin prescriptions that have already been dispensed and had a valid Special Authority at the time of dispensing.
- New prescriptions: If the patient is 19 years or older and has a Special Authority approval for melatonin, the Special Authority approval is not valid and their melatonin will not be funded.
- Repeats: If the patient is 19 years or older and has already collected their first month of funded melatonin prior to their Special Authority being cancelled, then that first dispensing is funded. However, any remaining repeats of melatonin will not be funded.
More information on Circadin use in children
The Circadin brand of melatonin is the only brand of melatonin registered in New Zealand. It is registered for people aged 55 years or over. This means that its use in children is “off-label” (a use not registered with Medsafe) and needs to be discussed with a doctor.
PTAC (the Pharmacology and Therapeutics Advisory Committee that provides PHARMAC with objective clinical advice) has looked at the evidence for using melatonin in this group of children and young people and has recommended that it is funded. You can read more about the Committee’s most recent recommendation [PDF, 240 KB] at this link (starting on page 26).
The New Zealand Formulary for Children is a good place to go for information on melatonin use in children, including information on dosing. The New Zealand Formulary for Children can be found at www.nzfchildren.org.nz(external link).
For more information on melatonin use in children see the BPACnz article: Melatonin is it worth losing any sleep over?(external link)
When should Circadin tablets be taken?
The Circadin brand of melatonin is a modified-released tablet. This means the tablet is specially formulated to release the melatonin over a longer period and should be taken 1-2 hours before expected bedtime and after food.
Can Circadin tablets be halved?
Circadin 2 mg modified-release tablet is meant to be swallowed whole and halving the tablets is not recommended by the supplier.
There is some evidence to suggest that when Circadin is halved it is still modified-release. This means it should be taken 1-2 hours before the expected bedtime, but since the supplier does not recommend halving the tablets it should be discussed with your doctor or pharmacist first.
See the article on Dissolution of Intact, Divided and Crushed Circadin tableta(external link) for more information.
What about crushing Circadin tablets?
The BPACnz article(external link) advises that for children who are unable to swallow tablets the modified-release tablets can be crushed and mixed with a drink.
This means the tablets would no longer be modified release and should be given immediately before bed time.
Crushing the Circadin tablets is not recommended by the supplier and would need to be discussed with your doctor or pharmacist first.
Last updated: 26 June 2018