Advanced Sleep Melatonin

Name: Advanced Sleep Melatonin

What is Advanced Sleep Melatonin (melatonin)?

Melatonin is a manmade form of a hormone produced in the brain that helps regulate your sleep and wake cycle.

Melatonin has been used in alternative medicine as a likely effective aid in treating insomnia (trouble falling asleep or staying asleep). Melatonin is also likely effective in treating sleep disorders in people who are blind.

Melatonin is also possibly effective in treating jet lag, high blood pressure, tumors, low blood platelets (blood cells that help your blood to clot), insomnia caused by withdrawal from drug addiction, or anxiety caused by surgery. A topical form of melatonin applied to the skin is possibly effective in preventing sunburn.

Melatonin has also been used to treat infertility, to improve sleep problems caused by shift work, or to enhance athletic performance. However, research has shown that melatonin may not be effective in treating these conditions.

Other uses not proven with research have included treating depression, bipolar disorder, dementia, macular degeneration, attention deficit hyperactivity disorder, enlarged prostate, chronic fatigue syndrome, fibromyalgia, restless leg syndrome, stomach ulcers, irritable bowel syndrome, nicotine withdrawal, and many other conditions.

It is not certain whether melatonin is effective in treating any medical condition. Medicinal use of this product has not been approved by the FDA. Melatonin should not be used in place of medication prescribed for you by your doctor.

Melatonin is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Melatonin may also be used for purposes not listed in this product guide.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Melatonin for Children

Parents may consider using melatonin to help their child who has a trouble falling asleep. Only use melatonin for your child under the care of a pediatrician or other medical sleep specialist. Insomnia or other sleeping disorders in children should always be evaluated by a medical professional.

Melatonin should not be used as a substitute for good sleep hygiene and consistent bedtime routines in children. According to Yale sleep specialist Dr. Craig Canapari, use of melatonin results in less difficulty with falling asleep, earlier time of sleep onset, and more sleep at night.

Products containing lower-dose melatonin for kids do exist on the U.S. market. However, long-term use of melatonin has not been studied in children and possible side effects with prolonged use are not known. Use for children with autism spectrum disorder or attention-deficit hyperactivity disorder should involve behavioral interventions and should be directed by a physician.

Delayed sleep phase disorder often occurs in teenagers and young adults, possibly due to alterations in endogenous melatonin production. Sleep onset is delayed by 3 to 6 hours compared with normal bedtime hours of 10 to 11 PM. Maintaining a consistent bedtime free of electronics for at least one hour prior to bedtime is especially important for children and adolescents.

Is Melatonin Approved by the FDA?

Melatonin is not approved by the FDA for any use. Melatonin falls under the FDA’s Dietary Health and Education Act as a dietary supplement. The FDA is not authorized to review the safety or effectiveness of dietary supplements like melatonin before they are marketed.

However, manufacturers must notify FDA about new ingredients prior to marketing. The FDA will only review (not approve) the ingredient for safety, but not effectiveness. If a manufacturer makes an unproven health claim or if the supplement is found to be unsafe the FDA can remove the OTC from the market.

Avoid buying dietary supplements from the Internet and from online pharmacies whose authenticity you cannot verify. It is important to remember that an OTC label that says “natural” melatonin supplement does not always mean it’s “safe” for consumption. Formulations that are United States Pharmacopeial (USP) Convention Verified can be considered most reliable in this regard; the label “USP” is found on the outside of the bottle. For example, all Nature Made melatonin products are verified by the USP.

Do Electronic Devices Alter Melatonin Levels?

Light at night blocks the production of melatonin, and this has been shown to cause sleep disturbances in people who use electronics that emit light at night. Researchers have found that light from electronic devices can block the release of natural hormone melatonin at night. The effect was most significant for younger children, with nighttime melatonin levels reduced by up to 37 percent in certain cases. This can also be problematic for children between ages 9 and 16.

Studies show that light after dark lowers melatonin levels which may lead to difficulty in initiating sleep. Electronic light-emitting devices such as the television, laptops, smartphones and tablets often find their way into the bedroom at night, or are used after dark. Children should not have electronics, including TVs, in their bedroom at bedtime and everyone should avoid use of light-emitting devices and screen time at least one hour before bedtime.

Does Food Contain Melatonin?

A study published in Food and Nutrition Research notes that certain food products do contain various amounts of melatonin as measured by immunological and chromatographic laboratory techniques. How consumption of these various foods might affect endogenous melatonin production sleep or was not evaluated:

  • Tomatoes
  • Walnuts
  • Rice/barley cereal
  • Strawberries, tart cherries
  • Olive oil
  • Wine, beer
  • Cow’s milk

Research finds that melatonin synthesis depends upon availability of the essential amino acid tryptophan, a needed component of the diet. If intake of tryptophan is severely restricted, synthesis of melatonin is significantly reduced in humans.

In the Nurses’ Health Study, no link was found between the consumption of various nutrients, such as folate, vitamin B6 and zinc and increased urinary melatonin excretion.

Diets rich in vegetables, fruits and grain products will contain considerable levels of dietary melatonin. However, the overall effect of dietary consumption on the eventual production of nighttime melatonin is very limited. Melatonin production is primarily driven by the effects of light and darkness and by age, declining as we get older.

How Much Does Melatonin Cost?

On average a 120-count bottle costs about $10.00, but prices can vary, depending upon the manufacturer and melatonin strengths purchased. Insurance will not pay for over-the-counter (OTC) melatonin product, although some plans may allow use of health savings account funds if a prescription for melatonin OTC is written by your doctor.

Uses

Melatonin is used for numerous conditions but has shown the most promise in short-term regulation of sleep patterns, including jet lag. Results from clinical trials are inconsistent.

Upsides

  • Melatonin is classed as a supplement which means it is available without a prescription from pharmacies, nutrition stores, and other retail outlets.
  • Melatonin may be used to treat jet lag, sleep disorders in the blind, shift-work sleep disorders, and for general insomnia. It is an antioxidant and is purported to have numerous other properties (such as boosting the immune system, treating headaches).
  • The majority of trials have investigated the use of melatonin for jet-lag. A review found melatonin to be very effective at decreasing jet lag from eastward flights crossing five or more time zones. A dosage of 0.5 mg/day immediately before bedtime once at the destination appears just as effective as a dosage of 5 mg/day; however, onset and quality of sleep is better with the 5mg dosage. The 2mg slow-release dose appears ineffective; suggesting that a short-lived, high-peak concentration of melatonin works better.
  • Melatonin appears more effective the more time zones crossed, and less effective for westward flights.
  • Occasional short-term use appears safe.

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • Dizziness, drowsiness, bed-wetting, headache, nausea and excessive daytime sedation are the most common side effects.
  • Melatonin may cause drowsiness that persists and affects a person's ability to drive or operate machinery the next day.
  • Not FDA approved.
  • May not be suitable for some people including those with epilepsy or autoimmune diseases, or taking warfarin. Caffeine and fluvoxamine may elevate plasma concentrations of melatonin. Melatonin may decrease plasma concentrations of nifedipine.
  • If melatonin is not taken at the right time of day it may cause drowsiness and delay adaption to local time.
  • Some melatonin supplements use naturally occurring melatonin derived from animal pineal tissue. Their use is to be discouraged because of the risk of contamination or viral transmission.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

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