Latest news with #melatonin
The Guardian
8 hours ago
- Health
- The Guardian
NHS manager ordered to stop selling ‘sleep drug-laced' children's gummies
An NHS manager has been stopped from selling children's gummies allegedly laced with undeclared levels of a prescription-only sleeping drug, the Guardian can reveal. Magnesium glycinate gummies for children who have trouble sleeping have been sold since March last year by Nutrition Ignition, an Epsom-based company owned by Sally Westcott, whose other job is a clinical therapy lead at Epsom and St Helier NHS trust. The Chinese-manufactured gummies are advertised as 'a natural way to help your child sleep better' and are described by Westcott on Facebook as 'especially beneficial in children with ADHD and autism'. But the adverts and the packaging do not reveal that the raspberry-flavoured sweets allegedly contain significant levels of melatonin, a hormone used for treating sleep problems that is only available in the UK if prescribed by a doctor. This week the drug regulator ordered Westcott to remove the gummies from her company's website and from the online retailer Amazon while it investigates. But the product remains available on eBay. Westcott said she was complying with the investigation and denied knowingly selling a prescription-only substance. The Medicines and Healthcare products Regulatory Agency (MHRA) was alerted to the gummies by two mothers who had bought the product online for their children. Last week the Guardian was able to buy a tub of 60 gummies for £19.49, including postage and packing, via Amazon without a prescription. They came with glowing five-star online reviews. One parent of a sleep-deprived child described the gummies as a 'godsend', another as 'magic'. The mothers, one a photographer and the other working in fintech, who both want to remain anonymous, had a hunch that the gummies contained more active ingredients than were listed on the label. Their suspicions were heightened when their young children, one of whom has been diagnosed with attention deficit hyperactivity disorder and the other who is suspected of having ADHD and autism, fell asleep only 30 minutes after eating the gummies. The women commissioned an independent company, Supplement Factory, to analyse the gummies. Its report, which the Guardian has seen, said they contained undeclared, but pharmacologically relevant, levels of melatonin. Each gummy contained 0.53mg of melatonin, the analysis estimated. The recommended starting dose for children is 0.5mg. Supplement Factory concluded that the inclusion of melatonin was unlawful as it breached the human medicines regulations 2012. 'A single gummy may sedate a child without clinical oversight,' Supplement Factory's report concluded. The mothers sent the report to the MHRA earlier this month. Amazon was also notified. This week the gummies were taken offline while the MHRA investigates. A spokesperson for the MHRA said: 'Patient safety is our top priority. In the UK, melatonin is an authorised medicine, and any product containing it as an ingredient is likely to be classified as a medicine. 'If a product falls under the definition of a medicine, it must hold a marketing authorisation ('licence') in order to be legally sold and supplied in the UK, unless covered by a special exemption.' It added: 'We take the reports very seriously and can confirm we are investigating these products further to determine what appropriate action is required. We are unable to comment further on the details of this investigation as it is ongoing.' In a statement Westcott said: 'We take any concerns regarding product safety, regulatory compliance and consumer trust extremely seriously. 'We are currently reviewing the information you have provided regarding the magnesium glycinate gummies. We have initiated an investigation into the matter in order to properly understand the facts and are in the process of further independent scientific testing of our products. 'Nutrition Ignition is a small business and has never knowingly sold products containing undeclared ingredients and we only work with manufacturers who meet third-party assured industry standards; specifically NSF [National Science Foundation] certification of conformity.' The photographer said: 'It's horrifying to read those reviews about children falling to sleep in minutes, when you know the reality of what's happening. It is scandalous that you can buy prescription drugs for children over the internet in this way. 'This case shines a light on how unregulated this industry is, and calls into question Amazon's responsibility in allowing misleading and potentially dangerous products being marketed and sold to the parents of children.' Her friend said: 'I feel deeply concerned about what has been uncovered. Melatonin is a prescribed medicine in the UK and parents/carers need to be made fully aware of what they are feeding their children.' She added: 'My daughter is diagnosed with ADHD and has been taking medication to manage. To assist with sleep at night, her doctor prescribed melatonin, which luckily she wasn't taking because along with the magnesium gummies, it could have been at a dangerous level in her system. The fact that the supplements market appears to be unregulated and being sold on Amazon with false claims is really worrying.' Melatonin gummies are available in China, the US and in some European countries without prescription despite doubts about their long-term safety. In the UK a hidden market has developed for melatonin gummies, particularly among parents of neurodivergent children. The ready availability of melatonin online has alarmed health experts who say its long-term health effects on children are unknown.
RNZ News
2 days ago
- Health
- RNZ News
Melatonin, ADHD medication and magic mushrooms - what are NZ's new changes in access to them?
Access to melatonin, psilocybin and ADHD treatment is changing. Photo: AFP / File / RNZ illustration Explainer - The government has changed regulations on several medications in the past fortnight. Here's what you need to know about melatonin, ADHD medicine and medicinal psilocybin access. Melatonin, which is used to treat sleeping problems, has up until now been tightly restricted in New Zealand, unlike many other countries. But it will soon be available over the counter at pharmacies, Associate Health Minister David Seymour said last week . It will be available in pharmacies as pills up to 5mg in packs with up to 10 days' supply, or pills up to 3mg. "Modified release doses" - pills, capsules, gels and medical devices which allow the drug to be administered over a specific period - could also be available with dosages of up to 2mg. Melatonin will remain prescription-only for children and adolescents , "following expert clinical advice to ensure proper oversight when used by younger patients," Seymour said. Melatonin is used to treat sleep disorders. Photo: Quin Tauetau/RNZ Melatonin is a hormone made by the pineal gland in your brain that helps regulate sleep cycles. It tends to decrease as we get older. Supplements are taken to help those with insomnia or other sleeping problems. "Most countries in the world allow you to buy it," Seymour said, noting Kiwis would often buy it on trips overseas and take it back home despite it being restricted here. "That makes no sense." One Auckland mother told RNZ recently that melatonin was "life saving" and a "game-changer" for her 10-year-old son with autism. Still, not everyone is convinced that it works. Studies have so far shown melatonin to be a "dud" in terms of effectiveness, Dr David Reith, an associate professor of pharmacology at the University of Otago, told RNZ last year. "The studies indicate it gets you to sleep 15 minutes quicker. But not that it keeps you asleep, improves the quality of your sleep, or increases the amount of time you sleep." Watch: David Seymour on changes to melatonin and psilocybin access It will take a little more time to see it on your chemist's shelf. Seymour said he called on the melatonin manufacturers of the world "to apply to bring their products into our country." "We are entirely dependent on the manufacturers to apply to have specific products available in New Zealand. The market dried up because it was so restricted nobody wanted to sell here. "But when we did this with pseudoephedrine it was a matter of months before the products were on the shelves and I hope we can beat that record." GPs and nurse practitioners will soon be able to diagnose and prescribe medications for attention-deficit hyperactivity disorder, or ADHD, to adults age 18 and over. The changes affect the stimulant medicines methylphenidate, dexamfetamine and lisdexamfetamine, also sold under various brand names. Medsafe and Pharmac announced the changes on Tuesday . Until now, it has required a written recommendation from a psychiatrist or paediatrician to start prescribing ADHD medications, a process which can take months. "I have heard stories of many people with ADHD who have been unable to get a diagnosis and treatment in a timely manner because of long wait items and costs associated with seeing a specialist," Mental Health Minister Matt Doocey said in announcing the change . Children and teenagers 17 and younger will be able to get prescriptions from nurse practitioners who work in mental health services as well as psychiatrists and paediatricians. Dr Anna Skinner, the Chief Clinical Advisor for Primary Care at Health New Zealand, told Checkpoint that the change would help eliminate barriers for people to get treatment. "People have been accessing private psychiatry at considerable personal costs," she said. Ritalin is one of several drugs that treat ADHD. Photo: CC 2.0 Health agencies have set the start date at 1 February 2026 to address potential supply issues related to methylphenidate or Ritalin, and to give more time for workforce preparation. However, not all GPs and nurse practitioners will be equipped to carry out the work immediately, so it will be important to talk to your physician about your options, Pharmac said. The assessments will not be done in your typical 15-minute GP visit and will possibly require multiple visits to specialised staff, Skinner said. "It's certainly not a 15-minute diagnosis so it's not something that everybody will be able to access the morning after the changes." In making the announcement Doocey said it was important to have consistency as the policy changes. "The Ministry of Health is working with sector representatives to develop a clinical principles framework for the assessment and treatment of ADHD. This will ensure there is quality and consistency for supporting patients with ADHD in New Zealand." Psilocybin, a chemical from certain mushrooms, has been used to treat depression. Photo: Pixabay Psilocybin is a chemical obtained from certain kinds of mushrooms. It's been used in spiritual rituals, recreationally and as medicine over the years - and picked up the tag "magic mushrooms". It's also become a possible treatment for depression, as psilocybin is believed to interact with serotonin receptors in the brain. Serotonin is a neurotransmitter which regulates mood and other bodily functions and is sometimes called "the happiness chemical". It will still be an unapproved medicine but available for clinical treatment for the first time outside of trials. "Psilocybin is a medicine that can treat untreatable depression," Seymour said in making the announcement. "It was first researched in the 1950s and '60s and more recently there's been extensive research and approvals by the FDA in the United States to be able to use these types of medicines." Australia made a similar move to allow prescriptions of it in clinical settings two years ago. However, initially its use will be very limited in New Zealand. Only one person at the moment in all of New Zealand - psychiatrist Dr Cameron Lacey, based in Christchurch. Speaking to RNZ recently he said it had taken "a long time, a lot of energy and perseverance" to get to the approval stage, which had taken around four years. The treatment isn't cheap in other countries, however - Dr Lacey said it could run from NZ$16,500 to NZ$40,000 for the course of psychotherapy and psilocybin sessions. He hoped it would be cheaper when it comes to New Zealand. "I'm hopeful we can work with Health New Zealand to create a funding pathway for those who have failed to respond to current standard treatments and endure significant symptoms to be able to get access to this treatment." The latest data from the New Zealand Drug Foundation shows the use of psychedelics - which includes substances such as LSD, psilocybin and ketamine - has doubled in the past six years. Dr Lacey will operate under strict reporting and record-keeping requirements, Seymour said. He hoped more psychiatrists would apply to use it. "If a doctor believes psilocybin can help, they should have the tools to try." Sign up for Ngā Pitopito Kōrero , a daily newsletter curated by our editors and delivered straight to your inbox every weekday.
Washington Post
3 days ago
- Health
- Washington Post
Melatonin doses can vary from what's on the label. Here's how much.
Food and Drug Administration researchers have identified dozens of melatonin supplements with doses well above or below the amount listed on the label. They analyzed 110 melatonin supplements purchased in 2023, focusing on ones marketed for children. Their study was first published in a peer-reviewed journal in October, but did not identify any of the products. The FDA's study is the largest of melatonin-containing products in the United States, the researchers noted in a peer-reviewed article on the results. The Washington Post filed a Freedom of Information Act request in November to obtain the names of the supplements tested, the results and any memo or report regarding the study. Among the supplements tested, researchers found that three products from Zarbee's, Robitussin and Creekside Natural Therapeutics varied the most from the melatonin declared, according to the documents from the FOIA request. Three other brands, WellYeah, Calmable and Nextdia, sold products that contained zero or close to zero detectable melatonin per serving, the documents show. Some pediatric sleep medicine specialists said melatonin should be treated like a prescribed medicine, not a supplement. They also advised that children should be given the smallest effective dose, starting at half a milligram, after parents have tried other ways to help them sleep. 'This is not a vitamin,' said Paul Gringras, a professor of sleep medicine at King's College in London and the president of the International Pediatric Sleep Association, a group that supports research on pediatric sleep medicine. 'It is the messenger that transmits a signal to keep our clock in time to virtually every organ in the body.' Tyish Hall Brown, the director of behavioral sleep medicine at Children's National Hospital in D.C., said reports of the variability in melatonin supplements are 'disconcerting.' But the dose in a serving is often still within what she considers an acceptable range (0.5 mg to 5 mg per serving) for a child or teenager, she said. 'We just have to be mindful of this inconsistency, and then monitor how they're reacting to the supplement that they're taking,' Hall Brown said. 'We should use the lowest dose that produces the desired effect.' Jeff Ventura, a spokesperson for the Council for Responsible Nutrition, a trade association for the supplement industry, said in an email that consumers — especially parents — should 'have access to products that are accurately labeled and responsibly manufactured.' Ventura also wrote that the findings 'reinforce the need for [the FDA] to take enforcement action against those companies that fail to meet these basic obligations.' To measure the ingredients, the FDA researchers compiled a list of 199 melatonin supplements sold in the United States. An FDA spokesperson said in an email that 'to mimic product searches of an average consumer, product selection was done through third-party online vendors using targeted keyword searches (e.g., 'Melatonin+Child').' The researchers froze and pulverized supplements to measure the melatonin. The FDA examined specific brands and dosages of products, providing documentation of the exact product tested. An FDA spokesperson did not respond to questions regarding the data provided or the researchers' conclusions in the study. The FDA spokesperson didn't say whether the agency has contacted companies regarding the test results but said in an email that the study's findings 'are being taken into consideration' as the agency evaluates the safety of melatonin supplements. Pieter Cohen, an associate professor of medicine at Harvard Medical School, who is a co-author of a 2023 letter in JAMA on melatonin supplements, said that his research and the FDA's study only provide a 'snapshot' regarding the melatonin in off-the-shelf supplements and that people shouldn't use the results to decide what brands to avoid buying. Cohen and other physicians recommend people search for melatonin supplements that are third-party-tested by U.S. Pharmacopeia (USP). A spokesperson for Kenvue, the maker of Zarbee's, said Zarbee's Sleep with Melatonin 'is an adult product' that has been discontinued 'at most major retailers but is still available online.' Sam Osborne, a managing partner for Creekside Natural Therapeutics, whose product had six times the amount of melatonin on the label, said in an email that the FDA's results 'were both a surprise and a disappointment to us.' 'We have removed the fruit chews from the market and discontinued our business with the contract manufacturer who made those products for us,' Osborne said. A spokesperson for Haleon, the company that owns Robitussin, said the Robitussin Naturals product line mentioned in the study, which had four times the amount of melatonin on the label, has been discontinued. A spokesperson for Kenvue said in a statement that 'the FDA permits the inclusion of some amount of overage to ensure that the product contains at least 100% of the ingredient quantity listed on the label throughout its shelf life.' Patti Zettler, a professor of law at Ohio State University, said in an email that the FDA 'has recognized' some supplement companies design products to have an additional amount of an ingredient 'so that the product has at least 100% of the claimed amount of the ingredient throughout its shelf life.' 'But companies also have an obligation under the law to ensure that their products meet safety standards,' Zettler said. Neal Fortin, a professor and the director of the Institute for Food Laws & Regulations at Michigan State University, said companies 'should know their product' and the degree to which the active ingredients in dietary supplement degrade over time. 'If they're relying on putting a whole bunch in extra just so you make sure you get what you have, that's bad manufacturing practices,' Fortin said. 'That's not allowed.' Supplement companies could either reformulate their product for more stability or shorten its shelf life so they don't have overages, Fortin said. 'Some of these things can be dangerous if they're in large amounts — or larger than expected,' he said. People associated with the companies behind the brands Calmable, Doctor's Finest and WellYeah did not respond to requests for comments. A representative for Nextdia declined to comment. Mike Poll, a senior purchaser for Nutrabulk, one of the three brands with the correct dosage, said in an email 'we are pleased but not surprised' by the results of the FDA study. Melatonin is a hormone our brain releases at night to regulate the body's sleep-wake cycle, or circadian rhythm. Melatonin supplements help a person transition to bedtime, but it is not a sedative, Hall Brown said. When someone is having a hard time falling asleep at an earlier bedtime, melatonin supplements can help them adjust their circadian rhythm, she said. For example, people often take melatonin to manage jet lag. Melatonin is considered a dietary supplement in the United States. The FDA doesn't regulate dietary supplements as rigorously as it does prescription medications, or test them for safety and efficacy. In recent years, more adults have started taking melatonin supplements before bedtime, and some parents give them to children, although the practice isn't universally supported. Melatonin supplements are generally considered safe for children older than 2 years old to take in small doses for short periods of time — days, not weeks or months, states the International Pediatric Sleep Association. But one survey showed that parents of school-age children were giving melatonin to their kids for 18 months, on average. Studies have found that melatonin can help children with autism or attention-deficit/hyperactivity disorder fall asleep faster and sleep longer. But there's limited evidence supporting use for other children, and less is known regarding long-term use of the supplements. Some physicians are concerned melatonin supplements could affect children's growth and development. 'We're selling an active hormone, we're giving it to our children, and we have no idea how much we're giving them,' Cohen said. 'We don't know the long-term effects — at all — of this product,' said Cora Collette Breuner, a professor of pediatrics at the University of Washington School of Medicine and member of the American Academy of Pediatrics. The American Academy of Pediatrics states melatonin 'should only be used' in consultation with a pediatrician and after establishing other healthy sleep habits. Muhammad Rishi, an associate professor of medicine at Indiana University School of Medicine and spokesperson for the American Academy of Sleep Medicine, said that 'the public needs to understand that melatonin is not a dietary supplement.' Other physicians said melatonin can help some children. 'Sometimes the benefits of helping a child sleep outweigh the minor risks, as long as you're treating it like a drug,' said Beth Malow, a professor of neurology and pediatrics at Vanderbilt University Medical Center who has conducted research on melatonin for children with autism. 'Using behavioral interventions is best, but it's not always possible.' Hall Brown said she works with parents to implement behavioral techniques first, such as having a consistent bedtime. Then she'll recommend melatonin as 'a second line of defense.' The side effects of melatonin supplements are typically mild but they are associated with vivid dreams, bed-wetting, grogginess, headaches and dizziness. All the physicians interviewed advised parents to consult a health care provider before giving a child melatonin. Children tend to fall asleep faster if they have a consistent bedtime and an evening wind-down routine. You can also create a 'cave-like' environment for the child that's cool and dark, Gringras said. Limit light and light-emitting devices such as tablets or phones because the light can suppress the brain's release of melatonin. The American Academy of Pediatrics recommends children avoid screens for at least one hour before bedtime. Parents who do try melatonin should employ a 'two-pronged approach,' pairing the drug with a bedtime routine, because the melatonin won't work forever, Gringras said. 'When it stops working,' he said, 'you want the young person to have learned good behavioral habits that will last for the rest of their life.' Aaron Schaffer contributed to this report.
The Guardian
20-06-2025
- Health
- The Guardian
Black-market melatonin use points to the need for a national sleep strategy
Your article on the rise of black-market melatonin use among parents highlights a troubling reality: families are being left with nowhere to turn when it comes to safe, effective sleep support ('I feel like a drug dealer': the parents using black-market melatonin to help their children sleep, 15 June). Our report Dreaming of Change: A Manifesto for Sleep revealed that nine out of 10 UK adults now experience sleep issues. Around 14 million people may be living with undiagnosed insomnia, and yet just one in six of those with symptoms has received a formal diagnosis. Despite National Institute for Health and Care Excellence (Nice) guidance recommending cognitive behavioural therapy for insomnia (CBT-I) as the first-line treatment since at least 2009, face-to-face is rarely available on the NHS. Nice has also recommended cost-saving digital CBT-I for over three years and yet this has still not been funded for patients nationally. Without access to effective non-drug interventions, families are turning to unregulated sleep aids out of desperation. But melatonin is not a catch-all solution – and unsupervised use, particularly in children, carries risks. We urgently need a national sleep strategy. That includes national availability of digital CBT-I, funding for CBT-I in every local integrated care board in the NHS, public health campaigns to improve sleep literacy, and better training for GPs, who are often left with little choice but to prescribe medication. Despite the known harms and guidance advising on their risks, NHS data shows that over 5m prescriptions for sleeping pills are still written each year, and the number of children receiving these drugs has tripled since 2015. Parents should not have to rely on imported supplements to help their children sleep. Sleep is a fundamental part of health, not a luxury. It's time the government treated it that BeeversCEO, The Sleep Charity Have an opinion on anything you've read in the Guardian today? Please email us your letter and it will be considered for publication in our letters section.
RNZ News
18-06-2025
- Health
- RNZ News
Melatonin to be sold over-the-counter at pharmacies
David Seymour. Photo: RNZ / REECE BAKER The government has announced melatonin will be made available to buy over-the-counter at pharmacies. Melatonin is a natural hormone that helps induce sleep, and is used to treat insomnia and jet lag, but has been classified as a prescription-only medicine in New Zealand. "Medsafe has assessed this and decided there's no reason why it shouldn't be available on pharmacy shelves right here at home," David Seymour announces on Wednesday. More to come... Sign up for Ngā Pitopito Kōrero , a daily newsletter curated by our editors and delivered straight to your inbox every weekday.
