TABLE 4-10 Relevant Data and Conclusions on Efficacy and Safety Reviews and Publications Identified for Melatonin

Review/Clinical Trial Reference Type of Study and Subjects Indication Control Dose Product SpecificationClinical Details and Outcomes Measured Conclusions/Results Adverse Events Profile Interactions with Pharmaceuticals, Foods, or Other Dietary Supplements
Arendt and Skene, 2005 Review of 14 studies Jet lag and shift work Various 1.8 mg sustained release or 5 mg fast release Sleep phase shifts 11 of 14 placebo controlled studies on the use of melatonin for jet lag found at least some benefit. The benefits included reduction in subjective jet lag, and improvements in sleep and alertness. The evidence for using melatonin to adapt to night-shift work was inconclusive. Exogenous melatonin is a vasodilator—it lowers core body temperature, and it can affect skin blood flow. Therefore, if taken in a cold environment it may accelerate heat loss None reported
Brzezinski et al., 2005 Meta-analysis of 7 studies n=284 subjects Insomnia Placebo Various None reported Polysomnography and actigraphy used to measure sleep onset latency, total sleep duration, sleep efficiency Melatonin treatment reduced sleep onset latency by an average of 4.0 minutes, increased sleep efficiency by 2.2%, and increased total sleep duration by 12.8 minutes. None reported None reported
Buscemi et al., 2005 Meta-analysis of 14 randomized controlled trials Insomnia and delayed sleep phase syndrome Placebo None reported None reported Sleep onset latency, sleep efficiency, wakefulness after sleep onset, total sleep time, REM sleep percentage Melatonin decreased sleep onset latency by an average of 7.2 minutes in insomniacs and by an average of 38.8 minutes in patients with delayed sleep phase syndrome. Some evidence that melatonin is not effective in treating primary sleep disorders over the short term (less than 4 wk). No significant difference observed between melatonin and placebo None reported
Buscemi et al., 2006 Meta-analysis Secondary sleep disorders or sleep disorders accompanying sleep restriction Placebo Various; 0.5 mg to 7.5 mg Various; mostly oral capsules and tablets Sleep onset latency, sleep efficiency, wakefulness after sleep onset, total sleep time, REM sleep percentage Change in sleep onset latency was not statistically significant. Although the increase in sleep efficiency in people with secondary sleep disorders was statistically significant with melatonin, the effect was small (1.9%) an increase of less than 10 min if the amount of time spent asleep for 8 h spent in bed. The occurrence of adverse events was similar for melatonin and placebo. The most commonly reported adverse events were headaches, dizziness, nausea, and drowsiness None reported
Morin et al., 2007 Review Insomnia, delayed sleep phase syndrome, jet lag Various Various; ranges from 0.3 mg to 5 mg None reported Sleep latency, sleep duration, sleep quality Although there is some evidence supporting the use of melatonin in treating jet lag and sleep disturbance caused by shift work, more research is needed before melatonin can be recommended as a treatment for insomnia. Common: fatigue, dizziness, headache, irritability, and drowsiness
Less common: mood changes, hypotension, atherosclerotic plaques, hyperglycemia, mild gastrointestinal distress, increased intraocular pressure, fluctuations in reproductive and thyroid hormones
Potential synergy with other sedative hypnotics
Wagner et al., 1998 Review Insomnia and circadian disorders Various 0.3 mg to 10 mg Various Many, including sleep quality, sleep latency, EEG, sleep duration The evidence may support melatonin use for circadian rhythm disorders and in patients with low melatonin levels such as the elderly; more evidence is needed before it can be recommended for insomnia in the general population. Fatigue, headache, dizziness, irritability None reported
Bliwise and Ansari, 2007 Database evaluation
n=31,044 adults (ages 18–61+); representative U.S. sample
Data from 2002 Alternative Health/Complementary and Alternative Medicine supplement to the National Health Interview Survey: 5.2% of the survey sample used melatonin of which 27.5% (standard error=3.93) endorsed insomnia as one reason for use; 5.8% of the survey sample mentioned insomnia in association with valerian and melatonin use. Women used it more than men (5.5:1). Melatonin showed a 13.9% usage rate in association with anxiety/depression. None reported None reported

From: 4, Other Dietary Supplements for Military Personnel

Cover of Use of Dietary Supplements by Military Personnel
Use of Dietary Supplements by Military Personnel.
Institute of Medicine (US) Committee on Dietary Supplement Use by Military Personnel; Greenwood MRC, Oria M, editors.
Washington (DC): National Academies Press (US); 2008.
Copyright © 2008, National Academy of Sciences.

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