Melatonin is a hormone naturally produced by the pineal gland in the brain, primarily in response to darkness. Its main function involves regulating the body’s sleep-wake cycle, also known as the circadian rhythm. This internal clock helps signal to the body when it is time to sleep and when to be awake. Many people use melatonin supplements to help with sleep disturbances such as jet lag or occasional insomnia.
Melatonin’s Legal Status in Japan
In Japan, melatonin is categorized as a pharmaceutical product (医薬品, iyakuhin), not a dietary supplement. It is strictly regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical and Medical Device Act (PMD Act), meaning it is not available over-the-counter. This contrasts with its status in many Western countries, such as the United States, where it is often sold freely as a supplement.
Japan’s conservative approach reflects concerns about potential health risks from long-term melatonin use. While some countries permit doses up to 10 mg or more, Japan limits prescribed doses to 1-3 mg per day, classifying it as a strictly controlled prescription drug. Unauthorized purchase or use of melatonin without a proper prescription is against the law.
Acquiring Melatonin in Japan
As a pharmaceutical product, melatonin is not sold over-the-counter in Japanese pharmacies or drugstores. Obtaining it requires a doctor’s prescription, usually at lower doses of 1-3 mg per day. While specific melatonin receptor agonists like Ramelteon exist, direct melatonin is available as a prescription medication.
For individuals traveling to Japan, importing melatonin for personal use is subject to specific regulations. Travelers are permitted to bring up to a one-month supply of prescription medication without special permission. For trips extending beyond one month, a “Yakkan Shoumei” (import certificate for medication) is required. This certificate necessitates providing details about the medication, its quantity, the traveler’s itinerary, and a doctor’s note explaining the medical necessity. Exceeding these limits or attempting to import melatonin for commercial purposes carries significant legal risks and can result in confiscation.
Alternative Sleep Aids in Japan
Given the strict regulations on melatonin, individuals in Japan often turn to alternative sleep aids. Over-the-counter sleep aids found in Japanese drugstores contain antihistamines like diphenhydramine hydrochloride. These medications induce drowsiness by blocking histamine receptors in the brain, offering temporary relief for occasional sleeplessness. Popular brands include SS Pharmaceuticals Drewell and HapYcom Dreamin Aid, though purchases are often limited to one box per customer.
Beyond pharmaceutical options, traditional Japanese practices and herbal remedies are utilized for sleep support. Valerian and chamomile are well-known herbal remedies, and traditional Japanese Angelica root extract has been studied for its anxiolytic effects that can promote sleep. Cultural practices like taking a hot bath (ofuro) before bedtime are common for relaxation and preparing the body for sleep. Embracing a minimalist sleep environment, using futons on tatami mats, and practicing “Shinrin-Yoku” (forest bathing) for stress reduction are also lifestyle adjustments that promote restful sleep.