Medsafe committee recommends melatonin sleep medication be reclassified

Medsafe’s Medicines Classification Committee has recommended this month that specially-trained pharmacists be able to dispense the sleep medication, melatonin (Circadin®), without prescription to New Zealanders with primary insomnia. This could happen as early as April 2019.

The committee has endorsed the model that the pharmacists undergo special training for this purpose and use a screening tool to help assess patients for referral to GPs to offer further help to patients with sleep disorders.

In a health sector collaboration first, the completed screening tool will be sent to the GP when a referral occurs. Under this model, only people 55 years and over with primary insomnia will be able to access this medicine. It will not be available without a prescription to people outside these criteria.

Circadin® is the only registered melatonin prolonged-release 2mg treatment in New Zealand.

The medication decreases the time to fall asleep (sleep latency), and improves the quality of sleep, morning alertness and quality of life in those suffering from primary insomnia who are 55 years and older.1

Aspen Pharmacare, Circadin’s supplier, says it is pleased that New Zealanders with insomnia will soon have greater access to a proven treatment for insomnia, one that doesn’t have tolerance or potential for misuse.

The company and reclassification expert Dr Natalie Gauld applied for Circadin® to be reclassified to improve access to melatonin for the quarter of New Zealand adults who have sleep problems.2

The MCC Minutes making the recommendation noted that “Pharmacists have experience managing insomnia and there are medicines currently classified as restricted for the treatment of insomnia. The proposal will make available a medicine with an acceptable risk-benefit profile and efficacy at a system level structure.”

Provided there are no valid objections, availability through pharmacists could occur as early as April 2019, once pharmacists have undergone the required training.

“We look forward to seeing the training in place and supporting pharmacists to help their community with an important and often overlooked condition,” says Aspen Pharmacare general manager, Michelle Kapinga.

Insomnia is common and debilitating, affecting health, work and quality of life, and increasing the rate of accidents.1,3-6

This reclassification will not apply to section 29 products. As unregistered medicines no section 29 product can be supplied without a prescription, regardless of the classification.

Aspen Pharmacare and Natalie Gauld say they greatly appreciate the considerable and valuable input on the model of supply from pharmacists, GPs, health professional organisations, and a doctor specialising in sleep disorders.

Pharmacists regularly advise patients with insomnia, and, under this model, will now be able to supply a proven medicine to appropriate patients 55 years and over for a maximum of 13 weeks.

“The model of care will see pharmacists triaging through to GPs people with underlying concerns, using the screening tool and their additional training,” explains Dr Gauld.

The screening tool is adapted from the Auckland sleep questionnaire from Professor Bruce Arroll and Dr Tony Fernando.

Notes for Sidebar:

Medicines Classification Committee recommendation:

That melatonin prolonged release 2 mg tablets should be reclassified from a prescription medicine to 'prescription except when' with the following conditions:

* supplied for the treatment of primary insomnia for adults aged 55 years or older for up to 13 weeks

* by a New Zealand registered pharmacist who has completed a training programme in mental health and insomnia approved by the Pharmacy Council and Pharmaceutical Society of New Zealand

* in a pack that has received consent from the Minister of Health or the Director-General.