August 9, 2023, 9:29 am | Read time: 7 minutes

Melatonin is known as the sleep hormone because it regulates the human day-night rhythm. However, it also performs other functions in the body. As a single preparation, it is available cheaply and without a prescription in some other countries—primarily to maintain a healthy sleep rhythm. In Germany, in addition to prescription drugs, there are various dietary supplements containing melatonin. How do these preparations affect the body? Are there risks, what does the research say? When does health insurance cover the costs? And is melatonin really the miracle cure for falling asleep?

How does melatonin affect sleep?

Melatonin is released by the pineal gland in the brain in darkness, causing us to become sleepy and the body to prepare for sleep. When it becomes light in the morning, the release decreases—signaling the body to wake up and get up.

What does a “disturbed melatonin balance” mean?

A disturbed melatonin balance occurs when the body does not have enough melatonin available at the appropriate times of day and night. This can have natural causes, such as the pineal gland releasing less with age. However, there are also factors in younger people that can affect the melatonin balance—such as irregular daily routines, shift work, or traveling to different time zones. The blue light from phone or computer screens is also said to inhibit hormone production. Therefore, scientists advise against reading on a smartphone or laptop in bed.

Can a melatonin deficiency be diagnosed by a doctor?

According to Dr. Hans Günther Weeß, psychotherapist and head of the Interdisciplinary Sleep Center at the Pfalzklinikum in Klingenmünster, it is possible to determine the melatonin balance through saliva or blood tests. However, the results are very imprecise. “Melatonin must be measured at different times of the day because the hormone level is constantly fluctuating,” Weeß explains to FITBOOK.

Are melatonin products the key to falling asleep well?

“No,” assures the expert to FITBOOK. “The melatonin balance is just a small cog in the entire cycle that controls sleep quality.” For example, someone who cannot sleep due to restlessness will not benefit from taking melatonin. A similar conclusion was reached by “Stiftung Warentest” in 2022. None of the over-the-counter sleep aids, including six melatonin preparations, showed the desired effect, it said. Instead, testers documented side effects such as abdominal pain.¹

Not least, melatonin has an antioxidant effect, meaning it reduces the impact of harmful free radicals that can otherwise cause cell aging and damage. This would not only be noticeable with wrinkle development. Much worse: Oxidative stress is primarily associated with cancer and cardiovascular diseases.

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Do melatonin products help with jet lag? And does health insurance cover it?

According to Dr. Weeß, those with only minor sleep problems could benefit from taking melatonin. It also helps with air travel across multiple time zones. “Taken daily, melatonin can help adjust to the time change and thus avoid jet lag,” the sleep specialist tells FITBOOK. The Joint Federal Committee of Health Insurance Funds (G-BA) has also addressed melatonin as a jet lag medication, specifically whether the product “Melatonin Vitabalans” is reimbursable in this context. They argue that during air travel across multiple time zones, sleep itself is not disturbed but merely occurs at a different time. Since “symptoms usually disappear on their own after a few days when the rhythm has readjusted, treatment is generally not medically necessary,” the G-BA explains. Melatonin as a jet lag aid is therefore not reimbursable.²

Weeß also largely refrains from using melatonin as a sleep aid in his sleep therapy practice after examining the drug’s effects. So far, scientific evidence for a positive influence on the sleep rhythm is lacking, according to the expert.

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Prescription melatonin medications in Germany

In Germany, the distribution of melatonin drugs with significant pharmacological effects is more strictly regulated due to a lack of studies on tolerability and possible side effects. A prescription from a specialist is required. “Circadin” (2 mg melatonin per tablet) for people over 55 and “Slenyto” for adolescents (1 mg active ingredient per tablet) are approved for prescription to treat poor sleep quality and sleep disorders (insomnia) in children and adolescents with autism spectrum disorders and/or Smith-Magenis syndrome.

Abroad, preparations with single doses of up to 5 milligrams of melatonin per tablet are available.

Dietary supplements with melatonin in drugstores

Following the example of the USA and the Netherlands, Germany also experienced a surge in melatonin-containing dietary supplements. These have the advantage (for the manufacturer) that they do not need to be tested and approved by the Federal Institute for Drugs and Medical Devices but are only subject to the food monitoring authorities of the federal states. Currently, our authorities tolerate dietary supplements with a dose of 0.5 to 1 milligram of melatonin per use. “Cefanight,” for example, is sold exclusively in pharmacies and contains 0.5 milligrams of melatonin per tablet; the Dm online shop offers melatonin products as capsules (0.5 mg per capsule), spray (1 mg per two sprays), powder (according to the manufacturer, 1.5 milligrams of melatonin per stick), or sleep teas (no specification); Rossmann offers capsules and gums with 1 mg per unit, and the webshop contains a similar number of products.

How do you take melatonin?

Unless otherwise discussed with the treating physician, according to the Circadin package insert, one tablet is taken daily, about one to two hours before bedtime. This dosage can be maintained for up to 13 weeks. To treat jet lag, Dr. Weeß recommends daily intake over the travel period. U.S. manufacturers and suppliers of melatonin preparations often recommend taking it 30 to 60 minutes before the desired bedtime, while other sources suggest about 20 minutes before going to bed.

More on the topic

Health Risks Melatonin for Kids Tested! “Stiftung Warentest” Advises Against All Products

Amino Acid Found in Tea Does L-Theanine Really Have a Calming Effect?

Possible side effects of taking melatonin

“The dose makes the poison,” is the expert’s assessment. Melatonin, in prescription doses, like any other drug, can have side effects, although they do not necessarily occur. What should not be forgotten: Melatonin is a hormone—and how sensitively an organism reacts to it varies. Online portals report consumers experiencing nightmares, migraines, irritability, and nervousness, as well as gastrointestinal issues and weight gain. Additionally, Dr. Weeß considers long-term negative effects on kidney and liver values possible, alongside potential hangover effects, such as next-day drowsiness. How to properly deal with sleep deprivation—and what you can do yourself if you can’t fall asleep, find out here.

Sources

• 1. Stiftung Warentest: Finally find peace again – Sleep aids in the test (2022, accessed on 08/07/2023)
• 2. Deutsche Apotheker-Zeitung: When does health insurance cover melatonin? (2022, accessed on 08/09/2023)