Moving on from Melatonin Mania

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Sleep health has been a growing topic of concern in recent years, with an increasing number of people struggling to achieve the restful, uninterrupted sleep necessary for overall well-being. According to The Centers for Disease Control and Prevention (CDC), most adults need at least seven hours of sleep each night, yet more than one in three American adults report falling short.

This surge in sleep deprivation has driven consumers toward various solutions, with melatonin emerging as a go-to “natural” remedy. Melatonin-based sleep aids have risen in popularity due to their effectiveness, affordability, and the fact that melatonin is a naturally occurring supposedly non-habit-forming hormone. Yet, despite its widespread use, emerging evidence suggests that melatonin may not be the ideal solution it once appeared to be. As such, consumers are now seeking alternatives, and non-melatonin sleep aids are beginning to capture attention.

The Downside of Melatonin

Despite melatonin’s popularity, concerns about its potential downsides have grown in recent years. One of the most significant issues is the lack of consensus around standardized dosing. While some people may achieve results with as little as 1 mg, others take as much as 10 mg per night, with around 5 mg being the most common. The wide range of recommended doses makes it difficult for consumers to know how much to take for optimal effectiveness without side effects.

In higher doses, melatonin can disrupt the body’s natural hormone production and interfere with the circadian rhythm, the internal clock that regulates sleep-wake cycles. When someone takes a high dose of melatonin, it can signal the brain to produce less of its own melatonin, leading to an imbalance in the natural sleep process. In these scenarios, melatonin levels spike and “burn off” too quickly, causing the user to wake up in the middle of the night and have difficulty falling back to sleep as the body struggles to maintain balanced levels. On the flip side, taking melatonin too late in the evening can lead to delay in effectiveness, which can cause lingering grogginess the next morning since the body’s melatonin reserves have not been fully depleted by wake-up time.

There are also some concerns about melatonin’s potentially adverse impacts on specific demographics. Pregnant and breastfeeding women are advised to avoid melatonin due to concerns about undesirable effects on infants. Children and teenagers may also face risks. The National Center for Complementary and Integrative Health (NCCIH) emphasizes the need for caution when considering melatonin for young individuals, due to limited research on its long-term safety in this age group. In addition, since melatonin is a hormone, it is possible that melatonin supplements could affect hormonal development, including puberty.

In addition, consumers taking certain medications – particularly anti-depressants such as selective serotonin reuptake inhibitors (SSRIs) - should be careful with melatonin intake due to potential interactions. Studies indicate that combining melatonin with SSRIs may reduce the effectiveness of these antidepressants. Similar concerns arise for consumers taking anti-anxiety medications such as Clonazepam.

The reasons for pause surrounding melatonin are reinforced abroad; outside the United States, the potential downsides of melatonin are more officially recognized. For example, in the EU, melatonin is more heavily regulated and not widely accessible “off the shelf” due to the possible side effects associated with it. Unlike in the USA, where melatonin is readily available over the counter, European consumers must consult with pharmacists before purchasing it, adding an extra layer of protection against inappropriate use. These differences in regulation underscore the growing recognition that melatonin may not be as universally safe as initially thought.

A New Day Dawns for Sleep Health

As arguments against melatonin mount, consumers are increasingly seeking non-melatonin alternatives. Though still in the early stages of market adoption, non-melatonin sleep aids are beginning to carve out a niche for themselves, offering holistic solutions that focus on relaxation and stress reduction, rather than directly inducing sleep.

At the heart of this shift is the understanding that sleep is a complex process involving multiple factors. While melatonin works by mimicking the body’s natural sleep hormone, many non-melatonin ingredients focus on calming the mind and alleviating stress and, in turn, preparing the body for sleep. This distinction is critical: rather than directly prompting sleep by making users more tired, these ingredients help set the stage for sleep by calming them down.

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For example, take Valerian Root, a prominent herb utilized to promote relaxation. While it doesn’t directly induce sleep, it helps ease anxiety and tension, allowing the mind to wind down naturally. Similarly, L-theanine, an amino acid found in green tea, is effective at reducing mental stress, which can often be a barrier to falling asleep. By promoting a state of calm, L-theanine can support restful sleep, without drowsiness, while maintaining mental clarity. Ashwagandha, another popular non-melatonin sleep aid, is known for lowering cortisol levels. Cortisol is the body’s natural “wake up” hormone, so having too much at bedtime can lead to restlessness. Therefore, ashwagandha supports relaxation by reducing the body's stress response.

These non-melatonin sleep aids can be especially appealing for populations like pregnant women, teenagers, and those on specific medications. By addressing the root causes of sleeplessness, such as stress and anxiety, they offer a more balanced path to better sleep – one that avoids the potential side effects of melatonin.

Sweet Dreams: The Rise of Gummies

As non-melatonin alternatives continue to gain traction, their delivery method has also evolved. Most notably, gummies have emerged as a preferred delivery method for both melatonin and non-melatonin sleep aids, and it is easy to see why. Gummies offer several advantages over traditional pills or tablets, particularly when it comes to taste and ease of use.

One of the primary challenges with many non-melatonin sleep aids is their taste. Several of the aforementioned natural ingredients have flavors that few find pleasant; Valerian Root especially has a pungent odor and bitter taste that can be off-putting for many people. Gummies help mask these flavors, making it more palatable and enjoyable for consumers to incorporate sleep aids into their nightly routine.

Such palatability bolsters an important aspect of natural sleep aids: adherence. While pharmaceutical sleep aids may provide immediate results, natural sleep aids often require consistent use over time to build up in the system. Because gummies are more enjoyable to consume, they increase the likelihood that individuals will stick with their regimen long enough to see results.

From a business and manufacturability standpoint, gummies complement their exponentially improved palatability with attractive cost-competitiveness. Any minimal gaps in production costs between gummies and other oral dosage forms can be recouped (and them some) by the added adherence they encourage, which leads to higher, more consistent likely sales.

Nutritional gummies do, however, require some level of expertise to manufacture. The process begins with a sugar or glucose base, to which a gelling agent such as gelatin or pectin (for vegan recipes) is added. The active ingredients are then blended into the mixture, which is poured into molds and allowed to set. Once the gummies are formed, they can be dusted with sugar or other flavor enhancers before final packaging.

As the sleep aid market continues to evolve, it’s clear that consumers are seeking safer, more holistic alternatives to melatonin. The growing interest in non-melatonin sleep aids reflects a broader understanding of sleep health—one that prioritizes relaxation, stress relief, and overall well-being rather than relying on quick fixes that may come with unintended consequences.

The rise of gummies as a delivery format not only enhances the palatability of these natural solutions but also encourages adherence, helping consumers achieve sustained and sustainable improvements in sleep quality. As demand for natural, non-habit-forming sleep aids grows, this shift toward non-melatonin options represents a promising future in the sleep health landscape.

About the Author

Chris-Mare Agenbag is Technical Solutions Manager for Sirio Pharma, a leading global nutraceutical contract development and manufacturing organization with expertise in an array of delivery formats, including gummies, softgels, capsules, tablets, powders, functional beverages, probiotics, and other innovative dosage forms. The company operates multiple state-of-the-art manufacturing sites across the United States, Germany and China. www.siriopharma.com