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Add to FavoritesThe answer to whether or not melatonin is a safe supplement is yes, and no. Before deciding to take a supplement, you should understand how it will work in your body and if you NEED to take it.
While many supplements are good for almost everyone and will at least not hurt you even if you don't need it, some should be considered more carefully. Melatonin is one of these.
Simply put, a person's body SHOULD produce melatonin anyway. It is necessary to regulate sleep cycles. Some people don't produce enough melatonin naturally, and these people usually suffer sleep interruptions, either in the form of not being able to fall asleep or, more often, falling asleep only to wake up within a couple of hours and then finding themselves unable to get back to sleep after their middle-of-the-night waking.
These are the people that can benefit from taking melatonin. Their body is already impaired with melatonin production, and they are already suffering from lack of sleep. Replacing the melatonin their bodies should produce naturally will help correct this.
However, there are many reasons that people have trouble sleeping. More often than not, the cause is actually stress. Other factors can interfere with sleep as well. These people may already be producing enough melatonin, but are not sleeping because of some other reason.
The problem comes when someone goes out and buys melatonin and starts taking it without knowing whether they need it or not. (And every customer who has come to my store to buy melatonin hasn't known whether or not they needed it.) It can be safe enough to try it if you can be unbiased enough to determine whether or not it actually helps. You should keep a sleep log for at least a few days before beginning melatonin, and continue it after beginning to take it. If you don't see an improvement within a very short time, you shouldn't continue to take melatonin.
The reason is that, as I said, the body naturally produces melatonin. If you begin to supplement that with extra melatonin, your body gets the signal that melatonin isn't needed. Continuing to take the melatonin supplement over time, if it is not needed, can "shut off" your body's natural mechanisms and you will then become melatonin deficient where you weren't before. In this way, the supplement can be "unsafe."
And if you were losing sleep for some reason other than low levels of melatonin, you still won't be able to sleep until that issue is addressed, but at the same time you will need to take melatonin supplements for the rest of your life.
It is a much better approach to try to evaluate what is the most likely cause of your lack of sleep. As stated before, stress is the most likely culprit. In the case of persons under stress whose thoughts tend to race when they lie down to sleep, the herb skullcap is often helpful. If the cause is physical pain or tension, such as from an injury, valerian root would be the first choice to try. There are a number of other herbs as well that are more specific to other kinds of insomnia. Melatonin is usually indicated first in cases where there is not a more obvious cause and/or when the person has experienced a major disruption in sleep cycles, such as a person on shift work or one who has moved across multiple time zones.
Even when melatonin is indicated, it should be used "as needed" and the person should attempt to wean off of it if the need is temporary and can resolve itself. For those persons who truly do not produce enough melatonin, there may be a need to continue to supplement throughout life.
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Yes
A more adequate question to ask would be: "Is melatonin a useful sleep remedy?"
One in five Americans suffers from some kind of sleep disorder. Sleep disorders are defined by a poor quality sleep that may result in daytime sleepiness or impaired functioning. These disorders may be either secondary to several medical or psychiatric diseases (such as depression) or primary (i.e. not related to any other abnormal conditions). The most common sleep disorders are insomnia and the delayed sleep phase syndrome (DSPS). The latter is characterized by difficulties in both falling asleep and in waking-up when planned (Buscemi et al., 2005).
Melatonin is a pineal gland hormone, involved in the regulation of sleep-wake cycles in humans. It has been largely used for many years now to treat sleep troubles, and it is generally viewed as a natural, effective and safe remedy (Devi & Shankar, 2008). However, its popularity has recently been questioned by some reviewers that analyzed the results of melatonin use in various studies.
Buscemi and co-workers (Buscemi et al., 2005) performed a systematic review of melatonin efficacy and safety in the management of primary sleep disorders. Fourteen randomized controlled trials (RCTs) were relevant to the efficacy review, including 279 participants. [An RCT is a high-quality research, where a group of subjects is randomly assigned to receive either the active drug (melatonin, in this case), or placebo (a neutral, inactive, and harmless substance), allowing for a statistical comparison of results between the two subgroups.] The authors found that, overall, melatonin reduced sleep onset latency by no more than 11 minutes, and by only 7 minutes in people with insomnia. These gains were seen as insignificant. A more important benefit was observed in the subpopulation with DSPS, where the average reduction in sleep onset latency was 39 minutes; however, this was based on only two studies involving less than 30 subjects (Buscemi et al., 2005). Ten studies (nine RCTs), concerning some 222 participants, were relevant to the safety review. The duration of melatonin administration was 3 months or less. There were few reports of adverse events after melatonin administration. The most common adverse events reported were headaches (13 events), dizziness (10 events), nausea (3 events), and drowsiness (3 events), but in all cases, there was no significant difference between melatonin and placebo (Buscemi et al., 2005).
The same research group also conducted a systematic review of the efficacy and safety of melatonin in the treatment of secondary sleep disorders and sleep problems associated with sleep restriction, such as jet lag and shiftwork disorder (Buscemi et al., 2006). Six RCTs with 97 participants showed no effect of melatonin on sleep onset latency in people with secondary sleep disorders, whereas nine RCTs with 427 participants failed to demonstrate any benefit of melatonin on reducing sleep onset latency in people with sleep disorders after sleep restriction. Seventeen RCTs with 651 participants provided no evidence of adverse reactions from melatonin, with short term use (three months or less) (Buscemi et al., 2006).
A very recent overview (Babineau, Goodwin, & Walker, 2008) of available research using melatonin in healthy children only found a few small-sized studies. One four-week RCT of 38 healthy children six to 12 years of age found that 5 mg of melatonin taken at 6 p.m. improved total sleep time by 37 minutes, but did not significantly change sleep latency (amount of time between going to bed and falling asleep) or wake-up time (Smits, Nagtegaal, van der, Coenen, & Kerkhof, 2001).2 Another four-week RCT of 62 children six to 12 years of age showed that 5 mg of melatonin at 7 p.m. advanced sleep onset by 57 minutes, advanced wake-up time by nine minutes, and decreased sleep latency by 17 minutes compared with placebo (Smits et al., 2003). Adverse effects seen with four weeks of treatment included headache, chills, decreased appetite, and dizziness, all of which resolved during the first week (Smits et al., 2003). One child developed epilepsy after four months of treatment with melatonin; however, the child was then started on sodium valproate and continued on melatonin without any further seizures (Smits et al., 2001). Long-term safety of melatonin is unknown (Arendt, 1997).
Sajith & Clarke thoroughly searched the literature to look for studies using melatonin to treat sleep disorders in children and adults with intellectual disabilities (ID). Most of the studies they found were uncontrolled (no placebo subgroup for comparison), and the few RCTs were of small size and short duration. The conclusion of the analysis was that melatonin was effective in reducing sleep onset latency, but somewhat less effective in improving total sleep time in these subjects. Also, melatonin was proved to be relatively safe for short-term use, but its long-term safety could not be established. The authors discussed concerns about potential drug interactions, possible effects on puberty and the use of melatonin in epilepsy, asthma and depressive disorders, without decisive remarks (Sajith & Clarke, 2007).
In conclusion, melatonin appears to be safe in both children and adults and in various settings, at least with short-term administration (one to three months). However, it's the efficacy of melatonin that seems questionable, especially in adults with either primary or secondary sleep disorders. It may be more effective in healthy children, and in both children and adults with intellectual disabilities, but there is still very weak evidence to support such benefits.
In other words, safe as it may be in short-term use, the question is: what good is taking melatonin anyway?
Reference List
Arendt, J. (1997). Safety of melatonin in long-term use (?). J Biol.Rhythms, 12, 673-681.
Babineau, S., Goodwin, C., & Walker, B. (2008). FPIN's clinical inquiries. Medications for insomnia treatment in children. Am Fam.Physician, 77, 358-359.
Buscemi, N., Vandermeer, B., Hooton, N., Pandya, R., Tjosvold, L., Hartling, L. et al. (2005). The efficacy and safety of exogenous melatonin for primary sleep disorders. A meta-analysis. J Gen.Intern Med, 20, 1151-1158.
Buscemi, N., Vandermeer, B., Hooton, N., Pandya, R., Tjosvold, L., Hartling, L. et al. (2006). Efficacy and safety of exogenous melatonin for secondary sleep disorders and sleep disorders accompanying sleep restriction: meta-analysis. BMJ, 332, 385-393.
Devi, V. & Shankar, P. K. (2008). Ramelteon: A melatonin receptor agonist for the treatment of insomnia. J Postgrad.Med, 54, 45-48.
Sajith, S. G. & Clarke, D. (2007). Melatonin and sleep disorders associated with intellectual disability: a clinical review. J Intellect.Disabil.Re s., 51, 2-13.
Smits, M. G., Nagtegaal, E. E., van der, H. J., Coenen, A. M., & Kerkhof, G. A. (2001). Melatonin for chronic sleep onset insomnia in children: a randomized placebo-controlled trial. J Child Neurol., 16, 86-92.
Smits, M. G., van Stel, H. F., van der, H. K., Meijer, A. M., Coenen, A. M., & Kerkhof, G. A. (2003). Melatonin improves health status and sleep in children with idiopathic chronic sleep-onset insomnia: a randomized placebo-controlled trial. J Am Acad.Child Adolesc.Psychiatry, 42, 1286-1293.
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