Safety Information

Revised: 11 February 2016

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M² logo Melatonin and the possible risk of hallucinations added to the medicines monitoring scheme

20 July 2015

The Centre for Adverse Reactions Monitoring (CARM) has received three reports of hallucinations associated with melatonin use. Hallucinations generally occurred the same night melatonin was taken. In two of the three reports, no other medicines were reported and in all three reports an improvement in symptoms was reported once the medicine had been stopped.

Products Affected

There is currently one melatonin-containing product approved for use in New Zealand. However, not all of the reports were associated with this product. There are other melatonin-containing products being used in New Zealand that have not been approved by Medsafe.

Product name Sponsor
Circadin Modified release tablet Pharmacy Retailing (NZ) Ltd T/A Healthcare Logistics


Circadin prolonged release tablets are for the short term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. The recommended dose is 2 mg once daily and may be continued for up to 13 weeks.

Additional Information

Hallucinations are not currently listed in the New Zealand data sheet for Circadin.

The overall benefit-risk balance of melatonin remains positive.

Advice on how to take this medicine and other possible side effects can be found in the Consumer Medicine Information (CMI) and data sheet.

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Regulator Actions

Medsafe is placing this safety concern on the medicines monitoring (M² Logo) scheme to obtain further information on this possible adverse reaction.  Please report any suspected adverse reactions with melatonin, in particular hallucinations.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to CARM.

Medsafe cannot give advice about an individual’s medical condition.  If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

Update to Original Communication

11 February 2016

During the M2 period (20 July 2015 to 31 January 2016), no further cases were reported to the Centre for Adverse Reactions Monitoring (CARM). The safety concern has been investigated and no link between melatonin and hallucinations was demonstrated. The balance of the benefits and risks of harm for melatonin remains positive and no further action is required at this time.

Medsafe will re-investigate this concern should more information become available.