Melatonin or sleep gummies, popular for aiding sleep, spark debate over their safety and regulation. Experts are warning of potential risks.
Melatonin or sleep gummies, popular for aiding sleep, spark debate over their safety and regulation. Healthcare experts warn of potential risks due to inconsistent dosages and lax oversight, urging caution and professional advice
You might have seen several advertisements with captions like, “Sleep like a baby”, “Blissful and sound sleep”, “Sleep tight, wake up with no hangover”, etc.
These are all the captions for the advertisements of an over-the-counter (OTC) sleep-inducing medicine — melatonin gummies. These gummies, which have swept into the marketplaces around the world, including India, claim to bestow upon people the coveted treasure of peaceful sleep.
In recent times, OTC sleep aids like these are being marketed heavily, with the promise of a good night’s sleep.
However, this growing trend is ringing alarm bells among healthcare professionals over the potential risks and long-term safety of using these supplements.
The concern stems from the lack of stringent regulation in the OTC market, where the purity and dosage of melatonin can vary significantly. Unlike prescribed medications, these supplements do not undergo rigorous checks by the Drug Controller General of India (DCGI), leading to variability that could have unforeseen consequences.
Dr Ravindra Mehta, Senior Pulmonologist and sleep expert at Apollo Hospitals, says that “these products are classic prototypes of OTC products which come with ingredients which are not necessarily prescription medications or regulated but are known to have some impact in the particular disease type”.
“These products have some dose of melatonin and some naturopathic products, and all of them are not regulated,” he tells South First.
Dr Satyanarayana Mysore, HoD, Department of Sleep Medicine at Manipal Hospital, explains that melatonin is the hormone responsible for regulating the sleep-wake cycle and is naturally produced by the brain’s pineal gland.
“It’s often referred to as the ‘sleep hormone’, as it plays a crucial role in regulating the body’s circadian rhythm, which is essentially our internal clock. This rhythm influences many bodily functions, including sleep,” he said.
He says that in the modern world, several factors are disrupting melatonin production and consequently affecting sleep. The pervasive use of screens emitting blue light, especially in the evenings, suppresses melatonin production, disrupting the natural sleep-wake cycle.
A nationwide survey shows five in 10 people from Karnataka and Telangana have sleep problems, post-Covid (Creative Commons)
“Additionally, irregular sleep schedules, common in today’s fast-paced lifestyle, interfere with the body’s circadian rhythm. Aging also plays a role, as the pineal gland becomes less efficient at producing melatonin over time.”
“High stress levels, along with lifestyle choices such as consuming caffeine or alcohol close to bedtime, further impact melatonin levels. Moreover, environmental changes like travelling across time zones or engaging in shift work can significantly disrupt the body’s internal clock, leading to sleep disturbances,” he explains.
The gummies are a dietary supplement which contains a synthetic form of melatonin, marketed as a quick fix for sleep disturbances, to aid in sleep.
They are often chewable and come in various flavours, making them an appealing alternative to traditional pills or tablets.
Dr Sheetal Chaurasia, a Pulmonary Medicine Consultant at Manipal Hospital in Whitefield in Bengaluru, says: “The key ingredients, mentioned in some of these OTC sleep gummies typically include: Melatonin and some natural herbs known for their sedative properties.”
“Common herbs include chamomile, valerian root and lavender. These herbs are traditionally used to promote relaxation and support sleep. It may also contain additional supplements like L-theanine, magnesium, or certain vitamins that are believed to aid in relaxation and improve sleep quality,” she tells South First.
Doctors claim that these supplements were finding their way into the lives of many people including adolescents, a group particularly vulnerable to the lure of quick solutions.
But here is the conundrum: While short-term use of melatonin is generally considered safe, long-term effects and safety in people, especially adolescents, remain under-studied, claim doctors.
Moreover, there’s the question of purity and dosage. In the absence of strict regulations such as those applied by the DCGI for other medications, the consistency and quality of OTC melatonin can vary wildly.
Dr Mehta explains: “By putting melatonin and naturopathy products together, packaging them and marketing it as the solution for taking care of a vital need such as sleep or targeting a vulnerable population which is not sleeping, you appeal to people by offering a naturopathic product in a well-packaged, well-advertised situation.”
“While melatonin is otherwise a safe drug. If the doses are off and not standardised, and with the combination of other unregulated products, it is known to cause some other disturbances which you have to be careful about,” he adds.
Since the dosage and timing of melatonin are essential, it is not entirely safe to use these products.
Clinically efficacy, actual data and scientific validation are not there in any of these OTC products.
Dr Satyanaryana says the seductive ease of these gummies could also overshadow underlying issues.
“Sleep challenges are often the facade to deeper troubles — excessive screen time, work/academic pressures, caffeine intake or lifestyle imbalances. Resorting to a gummy could very well be akin to placing a diya (lamp) at the doorstep while neglecting the darkness within,” he says.
He explains that there was also the matter of dependency. The body’s natural melatonin production could potentially be influenced by regular supplementation, though evidence remains inconclusive.
These gummies, unlike prescribed medication, can be varied in composition, with no stringent oversight to ensure their potency or purity. Resorting to a nightly gummy could merely mask the symptoms of a bigger and more systemic issue.
Lifestyle portrait of sleeping man
Melatonin gummies can contain varying amounts of melatonin, sometimes much higher than what the body naturally produces. High doses can lead to increased side effects such as headaches, dizziness, nausea, and drowsiness the next day.
Taking melatonin at the wrong time of day or for prolonged periods can potentially shift an individual’s circadian rhythm, which can cause long-term disruptions to the sleep-wake cycle.
“Since their use is not very regulated, the additives used in the gummies may trigger allergic reactions or may have some interaction with other medicines being used by a person,” says Dr Chaurasia.
She says overdosing and associated side effects needed to be considered as many sleep gummies contain added sugar and preservatives and could be hazardous for people who have other comorbidities like diabetes, kidney, liver disorders, etc.
There is a lack of long-term studies on the health effects of chronic melatonin use. There are concerns that excessive intake could affect hormonal balance and reproductive health.
Sleep gummies may not be suitable for very young children, especially those having underlying issues that need to be addressed such as stress, anxiety, or medical conditions, says Dr Chaurasia.
“It is essential to address the root cause of the sleep difficulties rather than relying solely on supplements. It’s prudent to consult a paediatrician before giving this kind of sleeping aid to kids,” she adds.
Representative pic of child sleeping (Wikimedia Common)
Also, as they look, feel, and taste like candy, it may lead to overconsumption by children.
Dr Sudhir Kumar, a neurologist at Apollo Hospital in Hyderabad, says some of the melatonin gummies also contain cannabidiol.
So, consuming melatonin gummies may result in accidental ingestion of much higher amounts of melatonin, and the risk is higher in children.
Meanwhile, Dr Satish Ramaiah, a Sleep Medicine Expert, also opines that though melatonin supplements are generally safe, they don’t address all sleep-related issues. He adds that It is not advisable to take it routinely.
Doctors insist that it is best to consult a physician or a sleep expert before consuming any such medications for lack of sleep.
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