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Melatonin: a guide to its use in the US

Dr Karen Martin
Reviewed by Dr Karen MartinReviewed on 19.10.2023 | 8 minutes read

Many people today face challenges with sleep due to their busy lives. For those seeking a solution, melatonin has emerged as a popular choice worldwide. Melatonin is a hormone naturally produced by the body's pineal gland and is known for regulating sleep patterns.

Understanding Melatonin

Melatonin may offer hope for those struggling with sleep disorders, providing relief for issues like insomnia or disrupted sleep patterns. It's often called the "sleep hormone" and is a critical player in the rhythm of our body's internal clock, which is known as the circadian rhythm. This rhythm acts as our biological timekeeper, regulating various bodily functions, including sleep-wake cycles, hormone production, and metabolism. It orchestrates when we feel sleepy and alert, helping to synchronize our sleep patterns with the day and night cycles.

When evening approaches and darkness falls, a signal is sent to our brain's pineal gland, prompting it to ramp up melatonin production. This surge in melatonin levels serves as a biological cue that it's time to wind down and prepare for sleep. As melatonin levels rise, our bodies feel more relaxed, tired, and ready to transition to rest.

External light cues don't just influence melatonin secretion; our internal body clock also influences it. This internal clock helps anticipate when melatonin production should increase daily, ensuring that our sleep-wake cycles remain synchronized with the 24-hour day-night cycle.

In addition to its role in promoting sleep, melatonin also plays a part in other essential functions within the body. It acts as a potent antioxidant, helping to scavenge harmful free radicals and protect cells from oxidative damage. Moreover, melatonin has been implicated in regulating immune function, supporting cardiovascular health, and modulating mood and cognitive function.

Disruptions to our natural melatonin production can occur due to various factors, such as exposure to artificial light at night, irregular sleep schedules, or certain medical conditions. These disruptions can interrupt our circadian rhythm, leading to sleep disturbances, fatigue, and other health issues.

Availability of melatonin

Melatonin is available for over-the-counter (OTC) use in the United States, but requires prescription in some countries (such as the UK and parts of Europe).

You may want to seek professional guidance before initiating use. Healthcare professionals can play a crucial role in assessing the appropriateness of melatonin therapy for each individual based on their specific circumstances, medical history, and sleep-related concerns. They typically conduct a comprehensive evaluation to determine the underlying causes of sleep disturbances and identify any potential interactions with other medications. This evaluation may involve reviewing the patient's sleep patterns, medical history, current medications, and lifestyle factors that could impact sleep quality.

If melatonin is deemed appropriate, patients receive specific instructions regarding melatonin therapy, the dosage, timing, and duration. These instructions are tailored to each individual's needs, but generally, it is taken just before bedtime. It should only be used short-term in adults.

Consulting a healthcare practitioner serves as a safeguard to ensure its safe and responsible use, minimizing the risk of misuse, abuse, or adverse effects.

Safety and side effects

When used correctly melatonin is usually safe for short-term use. However, like any medication, it can sometimes cause side effects, such as:

  • Tiredness

  • Headaches

  • Changes in mood or behaviour

Before starting melatonin treatment, it's crucial to talk to a healthcare professional about any potential risks or concerns.

Exploring alternatives

In addition to melatonin supplements, several alternative approaches can enhance sleep quality and promote overall well-being. These alternatives encompass a variety of strategies, ranging from lifestyle modifications to complementary therapies, each offering unique benefits and considerations.

Practicing Good Sleep Hygiene

One of the most fundamental ways to improve sleep quality is by adopting good sleep hygiene practices. This includes maintaining a consistent sleep schedule by going to bed and waking up at the same time every day, even on weekends. Creating a relaxing bedtime routine can also signal to the body that it's time to wind down and prepare for sleep. This may involve taking a warm bath, reading a book, or practicing relaxation exercises.

  • Pros: Good sleep hygiene is accessible to everyone and can be implemented without the need for additional resources or expenses. Establishing a consistent sleep schedule and bedtime routine can help regulate the body's internal clock, leading to more restful and refreshing sleep.

  • Cons: While practicing good sleep hygiene can be beneficial, establishing new habits and routines may require time and commitment. Additionally, individuals with underlying sleep disorders or medical conditions may find that good sleep hygiene alone is insufficient to address their sleep-related concerns.

Relaxation Techniques

Engaging in relaxation techniques before bedtime can help calm the mind and body, making it easier to fall asleep and stay asleep throughout the night. Techniques such as meditation, deep breathing exercises, progressive muscle relaxation, and guided imagery can promote feelings of relaxation and reduce stress and anxiety levels, contributing to better sleep quality.

  • Pros: Relaxation techniques are non-invasive, drug-free interventions that can be easily incorporated into daily routines. They offer a natural and holistic approach to improving sleep quality, with benefits extending beyond better sleep to include stress reduction, improved mood, and enhanced overall well-being.

  • Cons: While relaxation techniques can be effective for many individuals, they may require practice and consistency to yield noticeable results. Some people may also find it challenging to quiet their minds or relax their bodies, especially if they're dealing with high levels of stress or anxiety.

Diet and Nutrition

Making dietary modifications and optimizing nutritional intake can also impact sleep quality. Consuming a balanced diet that includes foods rich in sleep-promoting nutrients, such as tryptophan, magnesium, and melatonin precursors, can support healthy sleep patterns. Additionally, avoiding stimulants like caffeine and nicotine close to bedtime and limiting alcohol consumption can help prevent sleep disruptions.

  • Pros: Dietary changes offer a natural and sustainable approach to improving sleep quality, with potential benefits for overall health and well-being. By prioritizing nutrient-dense foods and avoiding substances that interfere with sleep, individuals can support their body's natural sleep-wake cycles and promote restorative sleep.

  • Cons: While diet and nutrition play a role in sleep health, their impact may vary depending on individual factors such as metabolism, dietary preferences, and underlying medical conditions. Making significant dietary changes can also require time and effort, and some individuals may find it challenging to adhere to restrictive diets or avoid certain foods.

Cognitive Behavioral Therapy for Insomnia (CBT-I)

CBT-I is a structured, evidence-based therapy that addresses the underlying cognitive and behavioral factors contributing to insomnia. It typically involves techniques such as cognitive restructuring, sleep restriction, stimulus control, and relaxation training to promote healthy sleep habits and eliminate sleep-related worries and anxieties.

  • Pros: CBT-I is highly effective in treating insomnia and improving sleep quality in the short and long term. It offers a comprehensive and individualized approach to addressing sleep disturbances, targeting the root causes of insomnia and empowering individuals to develop sustainable sleep habits.

  • Cons: Access to CBT-I may be limited, as it often requires referral to a trained therapist or sleep specialist. Additionally, undergoing CBT-I requires a significant time commitment and active participation on the part of the individual, as treatment typically involves multiple sessions and homework assignments.

Exploring these alternatives alongside melatonin supplements provides individuals with a range of options for improving sleep quality and addressing sleep-related concerns. By considering the pros and cons of each approach and tailoring interventions to their specific needs and preferences, individuals can take proactive steps towards achieving restful and rejuvenating sleep.

Medication Alternatives

In addition to melatonin supplements and non-medication approaches, there are over-the-counter (OTC) medications that individuals in the US may consider as alternatives to improve sleep quality. These medications are readily available without a prescription and can be purchased at pharmacies or retail outlets. It's essential to weigh the benefits and risks of OTC sleep aids and consider their suitability for addressing specific sleep-related concerns.

Diphenhydramine (Antihistamines)

Some OTC sleep aids contain diphenhydramine, an antihistamine with sedative properties. Diphenhydramine is commonly found in allergy medications and nighttime cold remedies. It works by blocking histamine receptors in the brain, leading to drowsiness and promoting sleep.

  • Pros: Diphenhydramine-based sleep aids are widely available and can effectively relieve occasional sleep disturbances. They are generally considered safe for most people when used as directed and may help individuals fall asleep faster and stay asleep longer.

  • Cons: Diphenhydramine can cause side effects such as drowsiness, dizziness, dry mouth, and blurred vision. It may also lead to next-day grogginess or impair cognitive function, particularly in older adults. Prolonged use of diphenhydramine for sleep may be associated with tolerance, dependence, and rebound insomnia.

Doxylamine (Antihistamines)

Like diphenhydramine, doxylamine is an antihistamine commonly used in OTC sleep aids. It works by blocking histamine receptors in the brain, leading to sedation and promoting sleep.

  • Pros: Doxylamine-based sleep aids are available without a prescription and can provide short-term relief for sleep difficulties. They may help individuals initiate sleep more quickly and experience longer periods of undisturbed sleep.

  • Cons: Like diphenhydramine, doxylamine can cause side effects such as drowsiness, dry mouth, constipation, and urinary retention. It may also increase the risk of falls, especially in older adults, and is not recommended for individuals with certain medical conditions, such as glaucoma, urinary retention, or severe liver disease.

Valerian Root

Valerian root is an herbal supplement derived from the roots of the Valeriana officinalis plant. It has been used for centuries as a natural remedy for insomnia and anxiety. Valerian root is believed to exert its sedative effects by increasing gamma-aminobutyric acid (GABA) levels in the brain, a neurotransmitter that promotes relaxation and sleep.

  • Pros: Valerian root is available over the counter and is generally well-tolerated by most people. It may help improve sleep quality, reduce the time it takes to fall asleep and alleviate mild symptoms of anxiety or stress.

  • Cons: While valerian root is considered safe for short-term use, it can cause side effects such as headache, dizziness, stomach upset, and daytime drowsiness. It may also interact with certain medications, including sedatives, antidepressants, and alcohol. Long-term safety and efficacy data for valerian root are limited, and its use should be cautiously approached, especially in individuals with underlying health conditions or those taking multiple medications.

Herbal Blends

Some OTC sleep aids contain proprietary herbal blends that promote relaxation and improve sleep quality. These blends often combine botanical ingredients, such as chamomile, passionflower, lemon balm, and lavender, each with purported calming and soothing properties.

  • Pros: Herbal blends offer a natural and holistic approach to sleep support, with potential benefits for relaxation and stress reduction. They are generally well-tolerated and may be suitable for individuals seeking non-pharmacological alternatives for sleep improvement.

  • Cons: The efficacy of herbal blends for sleep enhancement varies, and scientific evidence supporting their use is limited. While generally considered safe, herbal supplements can still cause adverse effects and may interact with certain medications. Additionally, the quality and potency of herbal products can vary between brands, making it essential to choose reputable manufacturers and consult with a healthcare professional before use.

When considering OTC medication alternatives for improving sleep quality, individuals should carefully evaluate each option's potential benefits and risks. It's advisable to consult with a pharmacist or healthcare provider to ensure that the chosen sleep aids are safe, appropriate, and compatible with individual health needs and preferences. Additionally, OTC sleep aids should be used judiciously and in accordance with labeled instructions to minimize the risk of adverse effects and dependency.

If the alternatives discussed above have been tried and have been met with limited success, talk to your doctor about whether prescription medication may be appropriate for you.


Understanding the significance of melatonin in regulating our sleep-wake cycles underscores its importance in maintaining overall health and well-being. Promoting healthy sleep patterns and ensuring proper melatonin production can support our body's natural rhythms and enhance our quality of life.

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This article has been written by UK-based doctors and pharmacists, so some advice may not apply to US users and some suggested treatments may not be available. For more information, please see our T&Cs.
Dr Karen Martin
Reviewed by Dr Karen Martin
Reviewed on 19.10.2023
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