Melatonin should not be prescribed in the NHS to treat the time lag, according to a review of the available evidence.
Its use for the indication should be added to the list of drugs that cannot be ordered under a General Medical Services Contract, according to the expert review on Drug and Therapeutics Bulletin (DTB) concluded.
Limited available evidence
Several clinical trials have evaluated the effect of melatonin on the symptoms of time lag. However, many of the trials were small, most were published between 1986 and 2005, and details of the source or pharmaceutical form of melatonin were not always available.
A Cochrane Review , published in 2002, initially examined 10 trials comparing melatonin with placebo for the treatment of time lag.
However, Dr. James Cave, editor-in-chief of DTB, co-author of the review, explained in a linked podcast: “Actually, they could only use four studies to get a combination of the data, and that amounts to 142 participants in total. Therefore, you can see the weight of the evidence here is not great. “
A 2015 meta-analysis of the same four studies combined data on the severity of the time lag for flights to the east and west. On a severity scale of 0 to 100, the reported severity with melatonin was 27 compared to 45 for placebo, an average difference of 17.7.
A previous review of melatonin by DTB in 1998 raised concerns about the absence of a product license to ensure its quality and safety. However, this has since been addressed with an authorized form of melatonin (Colonis Pharma Limited) for the short-term treatment of the time lag in adults.
A ‘modest effect’ for the time lag
The latest expert review concluded that “melatonin seemed to have a modest effect on the symptoms of time lag compared to placebo.”
He also observed adverse effects associated with melatonin treatment, including headache, nausea, drowsiness and sedation.
In addition, melatonin may increase the frequency of seizures in people with epilepsy, and was not recommended for people with autoimmune diseases, severe renal impairment or moderate or severe hepatic impairment.
While the licensing issue has been resolved, there were still “many unanswered questions” about the use of melatonin for the time lag, said deputy editor and review co-author of David Phizackerley DTB, in the podcast.
Only with a prescription or without a prescription?
Melatonin is a prescription drug in the United Kingdom, the rest of the EU, Japan, Australia and Canada.
In the United States, where melatonin is available without a prescription, its use has increased. A 2017 study in the Journal of clinical sleep medicine reported that the over-the-counter demand had more than doubled in the US. UU. between 2007 and 2012. In 2012, an estimated 3.1 million Americans took melatonin.
Dr. Cave said he saw no reason for the NHS to change its position since the last review. “I am also concerned about the possibility that the license slips, and that it is used for people with sleep problems in general, and it really is not a good way to deal with that,” he said in the podcast.
DTB drug review. Melatonin for the time lag. DOI: 10.1136 / dtb. 2019.000074