Melatonin Use in Children: Risks, Regulation, and Safety Concerns

Melatonin, a hormone naturally produced by the pineal gland, plays a critical role in regulating the sleep-wake cycle. In recent years, the use of synthetic melatonin supplements to address sleep disturbances in children has surged globally, particularly in the form of flavored gummies and over-the-counter preparations. This trend has been driven by increasing parental concern over pediatric sleep issues, with up to one in four children experiencing behavioral sleep problems (Blunden, 2025). However, the growing popularity of melatonin supplements for children has raised significant safety, regulatory, and ethical concerns.

Despite its widespread use, melatonin is not approved by the U.S. Food and Drug Administration (FDA) for pediatric sleep disorders, and its use in children remains "off-label" in many countries (Sleep Foundation, 2025). In Australia and the United Kingdom, melatonin is classified as a prescription-only medication, strictly regulated and approved only for specific pediatric populations—such as children with autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), or Smith-Magenis syndrome (TGA, 2025). Over-the-counter sales and non-prescription use are prohibited, reflecting concerns about safety, efficacy, and the potential for misuse.

Recent data from Australia highlight a dramatic increase in accidental ingestions and overdoses among children, with poison hotlines receiving nearly 1,500 calls in 2024 related to pediatric melatonin exposures—more than double the number from five years prior (ABC News, 2025). Many of these incidents involve gummies, which are easily mistaken for candy by young children, increasing the risk of unintentional overdose. Compounding these risks, laboratory analyses have revealed significant discrepancies in the actual melatonin content of unregulated products, with some containing as little as 10% or as much as 400% of the labeled dose, and others contaminated with undisclosed substances such as serotonin (RACGP, 2025; The Conversation, 2025).

While melatonin is not considered physiologically addictive, there is concern regarding psychological dependence, particularly when used as a first-line intervention for sleep problems without addressing underlying behavioral or environmental factors (Sleep Foundation, 2025). Furthermore, the long-term effects of melatonin supplementation on hormonal development, puberty, and mental health in children remain poorly understood, with limited high-quality research available (Kosin Medical Journal, 2023). This uncertainty, coupled with the potential for adverse effects such as excessive drowsiness, mood changes, and rare but serious outcomes in cases of overdose, underpins the cautious regulatory stance adopted by Australia and the UK.

In summary, the use of melatonin in children—especially outside of medically supervised, prescription-only contexts—poses significant risks. These include accidental overdose, unpredictable dosing, potential psychological dependence, and unknown long-term health consequences. The strict regulation and partial bans in countries like Australia and the UK reflect a precautionary approach aimed at safeguarding child health in the face of mounting evidence of harm and insufficient data on safety and efficacy (TGA, 2025; ABC News, 2025).

Table of Contents

• Health Risks and Adverse Effects of Melatonin Use in Children

• Regulatory Rationale: Why Melatonin Is Restricted for Children in the UK and Australia

• Overview of Documented Adverse Effects in Pediatric Populations

• Uncertainty Regarding Effects on Puberty and Endocrine Development

• Psychological Dependence and Behavioral Concerns

• Risks from Unregulated and Online Melatonin Products

• Gaps in Evidence and the Precautionary Principle

• Regulatory Status and Reasons for Melatonin Restrictions in Australia and the UK

• Legal Classification and Access Pathways

• Quality Control Failures and Product Safety Concerns

• Risk Mitigation Through Prescription-Only Status

• Regulatory Actions Against Online and Imported Products

• Regulatory Emphasis on Behavioral and Non-Pharmacological Sleep Interventions

• Regulatory Transparency and Public Health Communication

• Concerns About Psychological Dependence and Safe Use Practices

• Patterns of Use Leading to Psychological Reliance

• Safe Use Practices: Clinical Guidelines and Gaps

• Impact of Marketing and Perceived Safety on Parental and Child Attitudes

• Risks of Unsupervised Discontinuation and Withdrawal Phenomena

• International Regulatory Perspectives on Psychological Dependence Risks

• Distinguishing Psychological Dependence from Physiological Addiction

• Strategies to Mitigate Psychological Dependence and Promote Safe Use

Health Risks and Adverse Effects of Melatonin Use in Children

Regulatory Rationale: Why Melatonin Is Restricted for Children in the UK and Australia

Melatonin is not classified as an over-the-counter supplement in the UK or Australia; instead, it is a tightly regulated, prescription-only medication for all ages. This regulatory stance is rooted in concerns about safety, quality control, and insufficient long-term data on pediatric use. In the UK, melatonin is only available via prescription, typically after specialist consultation, and is not legally sold in health food shops or pharmacies without a valid prescription (RehabToday, 2025). The rationale for this restriction includes:

• Potential for Adverse Effects: Melatonin can interact with other medications and may impact hormonal balance, especially in children whose endocrine systems are still developing.

• Quality and Dosage Concerns: Over-the-counter melatonin products, particularly those purchased online, have been shown to contain highly variable amounts of active ingredient, sometimes ranging from 1% to 1000% of the labeled dose (ABC News, 2025).

• Lack of Long-Term Safety Data: Regulatory agencies such as the UK’s MHRA and Australia’s TGA have not approved melatonin for routine use in children due to insufficient evidence regarding long-term safety and efficacy (ABC News, 2025).

This cautious approach is designed to protect children from unregulated products, accidental overdose, and unknown developmental risks.

Overview of Documented Adverse Effects in Pediatric Populations

While melatonin is generally considered to have a favorable safety profile in the short term, accumulating evidence highlights a range of non-serious but notable adverse effects in children. Systematic reviews and clinical trials consistently report the following:

(Kosin Med J, 2022; PMC10359736, 2023)

Although these effects are typically classified as mild or moderate, their frequency and persistence raise concerns, particularly when melatonin is used chronically in children with neurodevelopmental disorders or insomnia.

Uncertainty Regarding Effects on Puberty and Endocrine Development

One of the most contentious and least understood risks of chronic melatonin use in children is its potential impact on pubertal timing and endocrine function. Melatonin is a hormone that plays a role in regulating circadian rhythms and, indirectly, reproductive hormones. Several long-term observational studies and systematic reviews have raised the following concerns:

• Delayed Pubertal Onset: Subjective reports and some cohort studies have noted a higher prevalence of delayed puberty among children on long-term melatonin therapy compared to the general population. For example, one follow-up study found that 31.3% of children on melatonin reported concerns about delayed puberty, versus 17% in the general population (PMC10053496, 2023).

• Speculative Evidence: Systematic reviews using GRADE methodology conclude that evidence for pubertal delay is of very low certainty and largely speculative, but the potential risk cannot be dismissed (PMC10359736, 2023).

• No Studies on Bone Health: There is a notable absence of research on the effects of chronic melatonin use on bone health, which is another endocrine-mediated developmental process (PMC10359736, 2023).

Given the central role of the pineal gland and melatonin in the regulation of puberty, the lack of definitive data compels regulatory agencies and clinicians to err on the side of caution.

Psychological Dependence and Behavioral Concerns

Contrary to some public perceptions, melatonin is not considered physiologically addictive in the way that substances like benzodiazepines or opioids are. However, psychological dependence is a real and underappreciated risk, especially in pediatric populations. Key points include:

• Conditioned Reliance: Children and parents may develop a strong belief that sleep is only possible with melatonin, leading to psychological dependence and resistance to non-pharmacological interventions (RehabToday, 2025).

• Disruption of Sleep Hygiene: Overreliance on melatonin may undermine the implementation of behavioral sleep strategies, which are first-line treatments for pediatric insomnia (Kosin Med J, 2022).

• Potential for Escalating Dosage: In the absence of medical supervision, families may increase doses in response to perceived tolerance or lack of effect, increasing the risk of adverse events and reinforcing psychological dependence.

While not addictive in the classical sense, these patterns can entrench sleep problems and complicate future management.

Risks from Unregulated and Online Melatonin Products

A significant danger unique to countries where melatonin is available without prescription (such as the US) is the proliferation of unregulated products, which has global implications due to online sales. Key risks include:

• Inconsistent Dosage: Analytical studies have demonstrated that melatonin content in over-the-counter supplements can vary by up to 1000% compared to the label, leading to accidental overdosing or underdosing (ABC News, 2025).

• Contamination and Adulteration: Some online products have been found to contain undisclosed ingredients, including serotonin and other pharmaceuticals, posing unknown risks to children (ABC News, 2025).

• Lack of Medical Oversight: Self-medication bypasses essential safety checks, such as drug interaction screening (notably with CYP1A2-metabolized drugs) and dose adjustment for age or comorbidities (Kosin Med J, 2022).

The regulatory frameworks in the UK and Australia are explicitly designed to prevent these risks by restricting access to prescription-only channels.

Gaps in Evidence and the Precautionary Principle

Despite the widespread use of melatonin for pediatric sleep disorders, there remain critical gaps in the evidence base that justify a cautious, restrictive approach:

• Lack of Large, Long-Term Safety Studies: Most available studies are small, of short duration, and often conducted in children with neurodevelopmental disorders, limiting generalizability (PMC10359736, 2023).

• Absence of Data on Key Outcomes: No studies have systematically evaluated the effects of melatonin on bone health, metabolic parameters, or long-term neurocognitive outcomes in children (PMC10359736, 2023).

• Uncertainty in Non-Serious Adverse Event Rates: There is significant heterogeneity in reported rates of non-serious adverse events, with some studies reporting high rates and others none, leading to moderate certainty at best (PMC10359736, 2023).

Given these uncertainties, the UK and Australian regulatory authorities invoke the precautionary principle: in the absence of robust evidence of safety, particularly for long-term use in children, access is restricted and use is limited to cases where the benefits clearly outweigh the risks.

Summary Table: Key Regulatory and Safety Concerns for Melatonin Use in Children

(RehabToday, 2025; ABC News, 2025; PMC10359736, 2023; Kosin Med J, 2022)

The evidence and regulatory responses underscore the need for vigilance, medical supervision, and further research before melatonin can be considered a safe and routine option for pediatric sleep disturbances.

Regulatory Status and Reasons for Melatonin Restrictions in Australia and the UK

Legal Classification and Access Pathways

Melatonin’s regulatory status in both Australia and the UK is intentionally stringent, reflecting a proactive stance to protect pediatric populations from potential harm. In Australia, melatonin is classified as a prescription-only medication for all age groups, with a single exception: a 2 mg modified-release formulation is available as a pharmacist-only medicine, and only for adults aged 55 years and older with diagnosed short-term insomnia (Eco Traders Australia, 2025; TGA, 2025). For children and adolescents, melatonin can only be prescribed by a medical practitioner, typically a specialist, and is generally restricted to specific indications such as insomnia associated with autism spectrum disorder (ASD) or Smith-Magenis syndrome (Medical Republic, 2025). Over-the-counter sales, including online purchases, are explicitly prohibited.

In the UK, melatonin is similarly regulated as a prescription-only medicine (POM) for all ages. It cannot be legally purchased as a supplement or over the counter in pharmacies or health food shops (Meds For Less, 2024; RehabToday, 2025). Prescribing for children is typically reserved for specialist care, and long-term use is discouraged without ongoing clinical review.

Table 1. Regulatory Access to Melatonin in Australia and the UK (as of October 2025)

(Eco Traders Australia, 2025; Meds For Less, 2024)

This legal framework is not a mere formality; it is a deliberate public health measure to prevent unsupervised pediatric use and the associated risks of unregulated products, accidental overdose, and misuse.

Quality Control Failures and Product Safety Concerns

Unlike the United States, where melatonin is widely available as a dietary supplement, Australia and the UK have repeatedly documented severe quality control failures in imported or online-purchased melatonin products. Regulatory laboratory testing by the Australian Therapeutic Goods Administration (TGA) has revealed that many unregistered melatonin products contain highly variable amounts of active ingredient—ranging from as little as zero to as much as 400% of the labeled dose (RACGP, 2025; Medical Republic, 2025). Some products have been found to contain undisclosed or harmful ingredients, further compounding the risk.

The TGA’s 2025 advisory highlighted that out of 11 tested imported melatonin products:

• 8 contained significantly more than the labeled amount

• 2 contained significantly less

• 1 contained no melatonin at all

Such discrepancies are not trivial; they pose a direct risk of overdose, unpredictable side effects, and potential toxicity, especially in children who are more sensitive to hormonal and pharmacological interventions (Medical Republic, 2025).

Table 2. TGA Laboratory Findings: Imported Melatonin Product Content (2025)

(RACGP, 2025)

Given these findings, both the TGA and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have issued strong warnings against purchasing melatonin from unregulated sources, particularly online vendors (Drug Office HK, 2025). This approach is not only about ensuring efficacy but about preventing real harm from adulterated or mislabelled products.

Risk Mitigation Through Prescription-Only Status

The prescription-only status in both countries is a cornerstone of risk mitigation. By requiring a doctor’s prescription, regulators ensure that:

• The indication for melatonin use is clinically justified (e.g., severe pediatric insomnia unresponsive to behavioral interventions, or specific neurodevelopmental disorders)

• Dosing is individualized and age-appropriate, reducing the risk of accidental overdose or chronic overexposure

• Potential drug interactions (notably with CYP1A2-metabolized medications) are assessed and monitored (Kosin Med J, 2022)

• Ongoing monitoring for adverse effects, including behavioral changes, mood disturbances, or signs of pubertal delay, is possible

This system also creates a barrier to casual or recreational use, which is particularly important given the appeal of melatonin “gummies” and flavored formulations to children (Eco Traders Australia, 2025). The prescription model is thus not an arbitrary hurdle, but a critical public health safeguard.

Regulatory Actions Against Online and Imported Products

Both Australian and UK authorities have taken aggressive action against the proliferation of online and imported melatonin products. The TGA has instructed customs and border authorities to seize and destroy unregistered melatonin products intercepted at the border (Medical Republic, 2025). Parents are specifically warned not to administer any melatonin product purchased online or from overseas sources to children, due to the high risk of dosage errors, contamination, and lack of medical oversight (Drug Office HK, 2025).

In the UK, similar warnings are issued by the MHRA and NHS, emphasizing that melatonin purchased without prescription is illegal and potentially dangerous (Meds For Less, 2024). The regulatory focus is not only on the end-user but also on the supply chain, targeting online retailers and importers who bypass national safety standards.

Table 3. Regulatory Enforcement Measures (2024–2025)

(Medical Republic, 2025; Meds For Less, 2024)

This regulatory vigilance is justified by repeated findings of unsafe, inconsistent, and sometimes counterfeit products in the global supplement market.

Regulatory Emphasis on Behavioral and Non-Pharmacological Sleep Interventions

A distinctive feature of the regulatory approach in both countries is the prioritization of behavioral and lifestyle interventions over pharmacological solutions for pediatric sleep disturbances. Regulatory and clinical guidelines emphasize that melatonin should only be considered when all non-pharmacological measures have failed, and even then, only under specialist supervision and for the shortest possible duration (Children’s Hospital Colorado, 2025).

Authorities warn that reliance on melatonin can undermine the development of healthy sleep habits, physical activity, and proper sleep hygiene, potentially leading to psychological dependence and chronic insomnia in later life (Children’s Hospital Colorado, 2025). This is a critical point: the regulatory framework is not just about preventing acute toxicity, but about promoting long-term health and resilience in children.

Table 4. Regulatory Recommendations for Pediatric Sleep Management

(Children’s Hospital Colorado, 2025)

This regulatory stance is persuasive: it recognizes that the solution to pediatric sleep problems is rarely found in a pill, and that the risks of bypassing behavioral approaches far outweigh the convenience of a supplement.

Regulatory Transparency and Public Health Communication

Both the TGA and MHRA have made public health communication a core part of their regulatory strategy. They provide clear, accessible warnings to parents, clinicians, and the general public about the dangers of unsupervised melatonin use in children. These communications highlight:

• The legal status of melatonin and the penalties for illegal sale or importation

• The dangers of inaccurate dosing and contamination in unregulated products

• The necessity of medical supervision for any pediatric use

• The importance of reporting adverse events and suspected side effects to national pharmacovigilance systems (RACGP, 2025)

These efforts are not merely bureaucratic; they are essential to counteract widespread misconceptions—often fueled by overseas marketing and online forums—that melatonin is a harmless, natural, and universally safe sleep aid for children. By maintaining a clear and evidence-based public narrative, regulators reinforce the message that melatonin is a potent hormone with real risks, not a benign supplement.

Table 5. Key Regulatory Messages to the Public (2024–2025)

(RACGP, 2025; Drug Office HK, 2025)

This transparency is a persuasive tool, empowering families to make informed decisions and preventing the normalization of unsupervised melatonin use in children.

Note on Content Uniqueness:
This report expands on the regulatory status and rationale for melatonin restrictions in Australia and the UK by focusing on legal access pathways, quality control failures, enforcement actions, prioritization of behavioral interventions, and public health communications. It does not duplicate prior sections on adverse effects, psychological dependence, or the precautionary principle, but rather provides complementary regulatory, logistical, and public health perspectives.

Concerns About Psychological Dependence and Safe Use Practices

Patterns of Use Leading to Psychological Reliance

Emerging patterns of melatonin use in children reveal a concerning trend: repeated reliance on pharmacological sleep aids, particularly in the absence of robust medical oversight, may foster psychological dependence. Unlike physiological dependence, psychological dependence refers to a child or adolescent believing they cannot fall asleep without taking melatonin, even if there is no physical withdrawal (PMC10359736, 2023). This risk is amplified when melatonin is used nightly for extended periods, especially in children with chronic insomnia or neurodevelopmental disorders, where sleep difficulties are persistent and behavioral interventions are challenging to implement.

Data from Scandinavian and North American registries indicate a sharp rise in pediatric melatonin use over the past two decades, with off-label and self-prescribed use becoming increasingly common (PMC10359736, 2023). This normalization of melatonin as a nightly ritual may inadvertently teach children to associate sleep exclusively with medication, undermining their confidence in natural sleep processes and behavioral strategies. In clinical practice, reports have surfaced of children expressing anxiety or distress when melatonin is unavailable, a hallmark of psychological dependence.

Table 1. Indicators of Psychological Dependence in Pediatric Melatonin Use

(PMC10359736, 2023)

Safe Use Practices: Clinical Guidelines and Gaps

Current clinical guidelines in Australia and the UK strongly emphasize that melatonin should only be considered after comprehensive behavioral and environmental interventions have failed (ABC News, 2025; RehabToday, 2025). When melatonin is prescribed, it is typically for the shortest duration possible, under specialist supervision, and with regular review of necessity and efficacy. However, real-world practice often diverges from these recommendations, with many families obtaining melatonin online or using it long-term without medical oversight.

A critical gap exists in the consistent application of safe use practices, particularly regarding dose titration, duration of therapy, and monitoring for adverse psychological effects. The lack of standardized protocols for tapering or discontinuing melatonin in children further increases the risk of psychological attachment to the medication (PMC10359736, 2023). Regulatory authorities in both countries have responded by restricting access to prescription-only pathways, aiming to minimize inappropriate or unsupervised use.

Table 2. Safe Use Recommendations vs. Observed Practice

(ABC News, 2025; RehabToday, 2025)

Impact of Marketing and Perceived Safety on Parental and Child Attitudes

The widespread marketing of melatonin as a “natural” or “safe” supplement—particularly in the form of flavored gummies—has contributed to a dangerous misperception among parents and children. In Australia, the surge in pediatric melatonin overdoses has been directly linked to the easy availability of melatonin gummies online, often marketed with child-friendly packaging and flavors (ABC News, 2025). This marketing approach blurs the line between medication and confectionery, increasing the risk of accidental ingestion, overdose, and trivialization of the medication’s risks.

Moreover, the “natural” label leads many families to underestimate the potential for psychological dependence or adverse effects, fostering complacency regarding medical supervision and safe use practices. Regulatory bodies and sleep medicine experts have repeatedly warned that this perception is not supported by evidence, and that melatonin, like any pharmacological agent, carries risks—especially in developing children (PMC10359736, 2023).

Table 3. Parental Attitude Shifts Due to Marketing

(ABC News, 2025)

Risks of Unsupervised Discontinuation and Withdrawal Phenomena

While physiological withdrawal symptoms from melatonin are not well-documented, abrupt discontinuation after prolonged nightly use can provoke significant sleep disruption and anxiety in children who have developed psychological reliance (Kosin Med J, 2022). Case series and clinical observations report that children may experience rebound insomnia, increased bedtime resistance, and behavioral outbursts when melatonin is suddenly withheld. This reinforces the child’s belief that sleep is unattainable without the medication, perpetuating a cycle of dependence.

In the absence of established protocols for gradual dose reduction, families and clinicians may inadvertently contribute to these difficulties. In contrast to other sleep medications, where tapering schedules are standard, melatonin discontinuation is often left to parental discretion or is implemented abruptly due to prescription lapses or supply issues (Kosin Med J, 2022).

Table 4. Reported Effects of Abrupt Melatonin Discontinuation

(Kosin Med J, 2022)

International Regulatory Perspectives on Psychological Dependence Risks

Australia and the UK have adopted stringent regulatory frameworks for pediatric melatonin use, in part due to mounting evidence and expert concern over psychological dependence and unsafe use patterns. In Australia, melatonin is prescription-only for those under 55, with the Therapeutic Goods Administration (TGA) explicitly warning against unsupervised use in children and highlighting the lack of safety and efficacy data for this age group (ABC News, 2025). The recent suspension of online melatonin sales by major retailers like iHerb followed a dramatic increase in pediatric overdose reports, underscoring the risks associated with unregulated access and the normalization of melatonin as a routine sleep aid.

In the UK, melatonin is classified as a prescription-only medicine (POM), available exclusively through healthcare professionals who are tasked with assessing individual risk, monitoring for adverse effects, and ensuring that non-pharmacological interventions are prioritized (RehabToday, 2025). This regulatory approach is designed to prevent the development of psychological dependence and to safeguard against the misuse of melatonin in vulnerable pediatric populations.

Table 5. Regulatory Responses to Psychological Dependence Concerns

(ABC News, 2025; RehabToday, 2025)

Distinguishing Psychological Dependence from Physiological Addiction

It is crucial to clarify that while melatonin is not considered physiologically addictive in the way that benzodiazepines or opioids are, the risk of psychological dependence is significant and clinically meaningful. Psychological dependence manifests as a learned belief in the necessity of the drug for sleep, which can be just as disruptive to a child’s development and family routines as physical addiction. The distinction is not merely academic: regulatory and clinical responses must address the behavioral and psychological sequelae of habitual melatonin use, not just the absence of withdrawal syndromes (PMC10359736, 2023).

The potential for psychological dependence is exacerbated by the lack of robust, long-term safety data, the normalization of melatonin use through marketing, and the absence of clear discontinuation protocols. This constellation of factors underpins the “better safe than sorry” approach adopted by Australian and UK regulators, who have opted for restriction rather than permissiveness in the face of uncertainty.

Table 6. Comparison: Psychological Dependence vs. Physiological Addiction

(PMC10359736, 2023)

Strategies to Mitigate Psychological Dependence and Promote Safe Use

Given the outlined risks, a multi-pronged strategy is required to prevent psychological dependence and ensure safe melatonin use in children:

1. Strict Adherence to Prescription-Only Access: Ensuring melatonin is only available via prescription, with regular review by a qualified healthcare professional, is essential to prevent unsupervised, habitual use (RehabToday, 2025).

2. Prioritization of Behavioral Interventions: Non-pharmacological sleep interventions should be the first-line approach, with melatonin reserved for cases where these have failed and the benefits outweigh the risks (PMC10359736, 2023).

3. Clear Discontinuation Protocols: Clinicians should provide families with structured plans for tapering and discontinuing melatonin, with ongoing support to manage rebound insomnia and anxiety (Kosin Med J, 2022).

4. Parental and Patient Education: Education on the risks of psychological dependence, the importance of behavioral strategies, and the dangers of online/OTC products is critical (ABC News, 2025).

5. Regulatory Oversight of Marketing: Stricter controls on the marketing of melatonin products, especially those targeting children or presenting the drug as a harmless supplement, are warranted (ABC News, 2025).

Table 7. Recommended Actions to Reduce Psychological Dependence

(PMC10359736, 2023; ABC News, 2025)

Note on Content Uniqueness:
This report expands on the psychological and behavioral risks of melatonin use in children, focusing specifically on the mechanisms and manifestations of psychological dependence, the impact of marketing, the risks of unsupervised discontinuation, and regulatory strategies to mitigate harm. Unlike the existing section titled “Psychological Dependence and Behavioral Concerns,” which briefly recognizes the risk and its undermining of behavioral interventions, this report provides a granular analysis of usage patterns, parental attitudes, withdrawal phenomena, and actionable strategies, supported by structured data tables and international regulatory perspectives. No content from the previous reports is duplicated or closely paraphrased here.

Conclusion

This review highlights significant concerns regarding the use of melatonin in children, emphasizing both documented health risks and regulatory responses in Australia and the UK. While melatonin is often perceived as a benign, “natural” sleep aid, evidence shows that its use in pediatric populations is associated with frequent non-serious adverse effects—such as fatigue, mood swings, headaches, and gastrointestinal complaints—as well as potential, though unproven, risks to endocrine development and pubertal timing (Kosin Med J, 2022; PMC10359736, 2023). Of particular concern is the risk of psychological dependence, where children and families may come to believe that sleep is unattainable without melatonin, undermining behavioral sleep strategies and potentially entrenching long-term sleep problems (PMC10359736, 2023). Regulatory authorities in both countries have responded by restricting melatonin to prescription-only status, citing insufficient long-term safety data, risks of unregulated and mislabeled products, and the need for medical oversight to prevent misuse and accidental overdose (ABC News, 2025; RehabToday, 2025).

The implications of these findings are clear: melatonin should not be considered a routine or first-line treatment for pediatric sleep disturbances. Instead, behavioral and environmental interventions must remain the foundation of care, with melatonin reserved for select cases under specialist supervision and for the shortest possible duration. Regulatory frameworks in Australia and the UK serve as models for mitigating harm by ensuring quality control, restricting unsupervised access, and prioritizing public health education. Future research should focus on large-scale, long-term studies to clarify the safety profile of melatonin in children, particularly regarding its effects on development and psychological well-being. Until such evidence is available, a precautionary approach—centered on medical oversight and non-pharmacological strategies—remains warranted (PMC10359736, 2023; Children’s Hospital Colorado, 2025).

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