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Melatonin

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Natural Standard Monograph, Copyright © 2009 (www.naturalstandard.com). Commercial distribution prohibited. This monograph is intended for informational purposes only, and should not be interpreted as specific medical advice. You should consult with a qualified health care professional before making decisions about therapies and/or health conditions.

Related Terms

  • 5-Methoxy-N-acetyltryptamine, acetamide, beta-methyl-6-chloromelatonin, BMS-214778, luzindole, mel, MEL, melatonine, MLT, N-acetyl-5-methoxytryptamine, N-2-(5-methoxyindol-3-ethyl)-acetamide, Ramelteon ((TAK-375) a selective MT1/MT2-receptor agonist).

Background

  • Melatonin is a hormone produced in the brain by the pineal gland, from the amino acid tryptophan. The synthesis and release of melatonin are stimulated by darkness and suppressed by light, suggesting the involvement of melatonin in circadian rhythm and regulation of diverse body functions. Levels of melatonin in the blood are highest prior to bedtime.
  • Synthetic melatonin supplements have been used for a variety of medical conditions, most notably for disorders related to sleep.
  • Melatonin possesses antioxidant activity, and many of its proposed therapeutic or preventive uses are based on this property.
  • New drugs that block the effects of melatonin are in development, such as BMS-214778 or luzindole, and may have uses in various disorders.

Evidence

Uses based on scientific evidence

These uses have been tested in humans or animals. Safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified healthcare professional.

Grade*

Jet lag

Several human trials suggest that melatonin taken by mouth, started on the day of travel (close to the target bedtime at the destination) and continued for several days, reduces the number of days required to establish a normal sleep pattern, diminishes the time it takes to fall asleep ("sleep latency"), improves alertness, and reduces daytime fatigue. Although these results are compelling, the majority of studies have had problems with their designs and reporting, and some trials have not found benefits. Overall, the scientific evidence does suggest benefits of melatonin in up to half of people who take it for jet-lag. More trials are needed to confirm these findings, to determine optimal dosing, and to evaluate use in combination with prescription sleep aids.

A

Delayed sleep phase syndrome (DSPS)

Delayed sleep phase syndrome is a condition that results in delayed sleep onset, despite normal sleep architecture and sleep duration. Although these results are promising, additional research with larger studies is needed before a stronger recommendation can be made.

B

Insomnia in the elderly

Several human studies report that melatonin taken by mouth before bedtime decreases the amount of time it takes to fall asleep ("sleep latency") in elderly individuals with insomnia. However, most studies have not been high quality in their designs and some research has found limited or no benefits. The majority of trials have been brief in duration (several days long), and long-term effects are not known.

B

Sleep disturbances in children with neuro-psychiatric disorders

There are multiple trials investigating melatonin use in children with various neuro-psychiatric disorders, including mental retardation, autism, psychiatric disorders, visual impairment, or epilepsy. Studies have demonstrated reduced time to fall asleep (sleep latency) and increased sleep duration. Well-designed controlled trials in select patient populations are needed before a stronger or more specific recommendation can be made.

B

Sleep enhancement in healthy people

Multiple human studies have measured the effects of melatonin supplements on sleep in healthy individuals. A wide range of doses has been used often taken by mouth 30 to 60 minutes prior to sleep time. Most trials have been small, brief in duration, and have not been rigorously designed or reported. However, the weight of scientific evidence does suggest that melatonin decreases the time it takes to fall asleep ("sleep latency"), increases the feeling of "sleepiness," and may increase the duration of sleep. Better research is needed in this area.

B

Alzheimer's disease (sleep disorders)

There is limited study of melatonin for improving sleep disorders associated with Alzheimer's disease (including nighttime agitation or poor sleep quality in patients with dementia). It has been reported that natural melatonin levels are altered in people with Alzheimer's disease, although it remains unclear if supplementation with melatonin is beneficial. Further research is needed in this area before a firm conclusion can be reached.

C

Antioxidant (free radical scavenging)

There are well over 100 laboratory and animal studies of the antioxidant (free radical scavenging) properties of melatonin. As a result, melatonin has been proposed as a supplement to prevent or treat many conditions that are associated with oxidative damage. However, well-designed trials in humans are lacking.

C

Attention deficit hyperactivity disorder (ADHD)

There is limited research of the use of melatonin in children with ADHD both on the treatment of ADHD and insomnia in ADHD children. A clear conclusion cannot be made at this time.

C

Benzodiazepine tapering

A small amount of research has examined the use of melatonin to assist with tapering or cessation of benzodiazepines such as diazepam (Valium®) or lorazepam (Ativan®). Although preliminary results are promising, further study is necessary before a firm conclusion can be reached.

C

Bipolar disorder (sleep disturbances)

There is limited study of melatonin given to patients with sleep disturbances associated with bipolar disorder (such as insomnia or irregular sleep patterns). No clear benefits have been reported. Further research is needed in this area before a clear conclusion can be reached.

C

Cancer treatment

There are several early-phase and controlled human trials of melatonin in patients with various advanced stage malignancies, including brain, breast, colorectal, gastric, liver, lung, pancreatic, and testicular cancer, as well as lymphoma, melanoma, renal cell carcinoma, and soft-tissue sarcoma. Currently, no clear conclusion can be drawn in this area. There is not enough definitive scientific evidence to discern if melatonin is beneficial against any type of cancer, whether it increases (or decreases) the effectiveness of other cancer therapies, or if it safely reduces chemotherapy side effects.

C

Chemotherapy side effects

Several human trials have examined the effects of melatonin on side effects associated with various cancer chemotherapies. Although these early reported benefits are promising, high-quality controlled trials are necessary before a clear conclusion can be reached in this area. It remains unclear if melatonin safely reduces side effects of various chemotherapies without altering effectiveness.

C

Circadian rhythm entraining (in blind persons)

Limited human study is available in this area. Present studies and individual cases suggest that melatonin, administered in the evening, may correct circadian rhythm. Large, well-designed controlled trials are needed before a stronger recommendation can be made.

C

Depression (sleep disturbances)

Depression can be associated with neuroendocrine and sleep abnormalities, such as reduced time before dream sleep (REM latency). Melatonin has been suggested for the improvement of sleep patterns in patients with depression, although research is limited in this area. Further studies are needed before a clear conclusion can be reached.

C

Glaucoma

It has been theorized that high doses of melatonin may increase intraocular pressure and the risk of glaucoma, age-related maculopathy and myopia, or retinal damage. However, there is preliminary evidence that melatonin may actually decrease intraocular pressure in the eye, and it has been suggested as a possible therapy for glaucoma. Additional study is necessary in this area. Patients with glaucoma taking melatonin should be monitored by a healthcare professional.

C

Headache prevention

Several small studies have examined the possible role of melatonin in preventing various forms of headache, including migraine, cluster and tension-type headache (in people who suffer from regular headaches). Limited initial research suggests possible benefits in all three types of headache, although well-designed controlled studies are needed before a firm conclusion can be drawn.

C

High blood pressure (hypertension)

Several controlled studies in patients with high blood pressure report small reductions blood pressure when taking melatonin by mouth (orally) or inhaled through the nose (intranasally). Better-designed research is necessary before a firm conclusion can be reached.

C

HIV/AIDS

There is a lack of well-designed scientific evidence to recommend for or against the use of melatonin as a treatment for AIDS. Melatonin should not be used in place of more proven therapies, and patients with HIV/AIDS should be treated under the supervision of a medical doctor.

C

Inflammatory bowel disease (IBS)

Based on preliminary study, melatonin is a promising therapeutic agent for IBS. Further research is needed before a recommendation can be made.

C

Insomnia (of unknown origin in the non-elderly)

Study results have been inconsistent, with some studies reporting benefits on sleep latency and subjective sleep quality, and other research finding no benefits. Most studies have been small and not rigorously designed or reported. Better research is needed before a firm conclusion can be drawn.Notably, several studies in elderly individuals with insomnia provide preliminary evidence of benefits on sleep latency (discussed above).

C

Parkinson's disease

Due to very limited study to date, a recommendation cannot be made for or against the use of melatonin in Parkinsonism or Parkinson's disease. Better-designed research is needed before a firm conclusion can be reached in this area.

C

Periodic limb movement disorder

There is very limited study to date for the use of melatonin as a treatment in periodic limb movement disorder. Better-designed research is needed before a recommendation can be made in this area.

C

Preoperative sedation / anxiolysis

Results are promising, with similar results reported for melatonin as for benzodiazepines such as midazolam (Versed®), and superiority to placebo. There are also promising reports using melatonin for sedation/anxiolysis prior to magnetic resonance imaging (MRI). However, due to weaknesses in the design and reporting of the available research, better studies are needed before a clear conclusion can be drawn.Melatonin has also been suggested as a treatment for delirium following surgery, although there is little evidence in this area.

C

REM sleep behavior disorder

Limited case reports describe benefits in patients with REM sleep behavior disorder who receive melatonin. However, better research is needed before a clear conclusion can be drawn.

C

Rett syndrome

Rett syndrome is a presumed genetic disorder that affects female children, characterized by decelerated head growth and global developmental regression. There is limited study of the possible role of melatonin in improving sleep disturbance associated with Rett syndrome. Further research is needed before a recommendation can be made in this area.

C

Schizophrenia (sleep disorders)

There is limited study of melatonin for improving sleep latency (time to fall asleep) In patients with schizophrenia. Further research is needed in this area before a clear conclusion can be reached.

C

Seasonal affective disorder (SAD)

There are several small, brief studies of melatonin in patients with SAD. This research is not well designed or reported, and further study is necessary before a clear conclusion can be reached.

C

Seizure disorder (children)

The role of melatonin in seizure disorder is controversial. Better evidence is needed in this area before a clear conclusion can be drawn regarding the safety or effectiveness of melatonin in seizure disorder.

C

Sleep disturbances due to pineal region brain damage

Several published cases report improvements in sleep patterns in young people with damage to the pineal gland area of the brain due to tumors or surgery. Due to the rarity of such disorders, controlled trials may not be possible. Consideration of melatonin in such patients should be under the direction of a qualified healthcare provider.

C

Sleep in asthma

Based on preliminary study, melatonin may improve sleep in patients with asthma. Further studies looking into long-term effects of melatonin on airway inflammation and bronchial hyper-responsiveness are needed before melatonin can be recommended.

C

Smoking cessation

Although preliminary results are promising, due to weaknesses in the design and reporting of this research, further study is necessary before a firm conclusion can be reached.

C

Stroke

At this time, the effects of melatonin supplements immediately after stroke are not clear.

C

Tardive dyskinesia

Tardive dyskinesia (TD) is a serious potential side effect of antipsychotic medications, characterized by involuntary muscle movements. Limited small studies of melatonin use in patients with TD report mixed findings. Additional research is necessary before a clear conclusion can be drawn.

C

Thrombocytopenia (low platelets)

Increased platelet counts after melatonin use have been observed in patients with decreased platelets due to cancer therapies (several studies reported by the same author). Stimulation of platelet production (thrombopoeisis) has been suggested but not clearly demonstrated. Additional research is necessary in this area before a clear conclusion can be drawn.

C

Ultraviolet light skin damage protection

It has been proposed that antioxidant properties of melatonin may be protective. Further study is necessary before a clear conclusion can be drawn about clinical effectiveness in humans.

C

Work shift sleep disorder

There are several studies of melatonin use in people who work irregular shifts, such as emergency room personnel. Results are mixed. Additional research is necessary before a clear conclusion can be drawn.

C

*Key to grades:

A: Strong scientific evidence for this use;
B: Good scientific evidence for this use;
C: Unclear scientific evidence for this use;
D: Fair scientific evidence against this use (it may not work);
F: Strong scientific evidence against this use (it likely does not work).

For full grading rationale, click here.

Uses based on tradition or theory

The below uses are based on tradition or scientific theories. They often have not been thoroughly tested in humans, and safety and effectiveness have not always been proven. Some of these conditions are potentially serious, and should be evaluated by a qualified health care professional

Acetaminophen toxicity, acute respiratory distress syndrome (ARDS), aging, aluminum toxicity, asthma, beta-blocker sleep disturbance, cancer prevention, cardiac syndrome X, cognitive enhancement, colitis, contraception, critical illness/ICU sleep disturbance, depression, edema (swelling), duodenal ulcer, erectile dysfunction, fibromyalgia, gastroesophageal reflux disease (GERD), gentamicin-induced kidney damage, glaucoma, heart attack prevention, heart disease, hyperpigmentation, immunostimulant, interstitial cystitis, intestinal motility disorders, itching, kidney damage (amikacin-induced, cyclosporin-induced), lead toxicity, liver damage, melatonin deficiency, memory enhancement, multiple sclerosis, neurodegenerative disorders, noise-induced hearing loss, pancreatitis, polycystic ovarian syndrome (PCOS), postmenopausal osteoporosis, post-operative adjunct, post-operative delirium, prevention of post-lung transplant ischemia-reperfusion injury, rheumatoid arthritis, sarcoidosis, sedation, sexual activity enhancement, schistosomiasis, sudden infant death syndrome (SIDS) prevention, tachycardia, tinnitus (ringing in the ears), tuberculosis, tuberous sclerosis, ulcerative colitis, wasting, withdrawal from narcotics, wound healing.


Safety

The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare professional before starting a new therapy. Consult a healthcare professional immediately if you experience side effects.

Allergies

  • There are rare reports of allergic skin reactions after taking melatonin by mouth. Melatonin has been linked to a case of autoimmune hepatitis.

Side Effects and Warnings

  • Based on available studies and clinical use, melatonin is generally regarded as safe in recommended doses for short-term use. Available trials report that overall adverse effects are not significantly more common with melatonin than placebo. However, case reports raise concerns about risks of blood clotting abnormalities (particularly in patients taking warfarin), increased risk of seizure, and disorientation with overdose.
  • Commonly reported adverse effects include fatigue, dizziness, headache, irritability, and sleepiness, although these effects may occur due to jet-lag and not to melatonin itself. Fatigue may particularly occur with morning use or high doses, and irregular sleep-wake cycles may occur. Disorientation, confusion, sleepwalking, vivid dreams and nightmares have also been noted, with effects often resolving after cessation of melatonin. Due to risk of daytime sleepiness, those driving or operating heavy machinery should take caution. Headache has been reported. Ataxia (difficulties with walking and balance) may occur following overdose.
  • It has been suggested that melatonin may lower seizure threshold and increase the risk of seizure, particularly in children with severe neurologic disorders. However, multiple other studies actually report reduced incidence of seizure with regular melatonin use. This remains an area of controversy. Patients with seizure disorder taking melatonin should be monitored closely by a healthcare professional.
  • Mood changes have been reported, including giddiness and dysphoria (sadness). Psychotic symptoms have been reported, including hallucinations and paranoia, possibly due to overdose. Patients with underlying major depression or psychotic disorders taking melatonin should be monitored closely by a healthcare professional.
  • Melatonin should be avoided in patients using warfarin, and possibly in patients taking other blood-thinning medications or with clotting disorders.
  • Melatonin may cause drops in blood pressure. Caution is advised in patients taking medications that may also lower blood pressure. Based on preliminary evidence, increases in cholesterol levels may occur. Caution is therefore advised in patients with high cholesterol levels, atherosclerosis, or at risk for cardiovascular disease. Abnormal heart rhythms have been associated with melatonin.
  • Elevated blood sugar levels (hyperglycemia) have been reported in patients with type 1 diabetes (insulin-dependent diabetes), and low doses of melatonin have reduced glucose tolerance and insulin sensitivity. Caution is advised in patients with diabetes or hypoglycemia, and in those taking drugs, herbs, or supplements that affect blood sugar. Serum glucose levels may need to be monitored by a healthcare provider, and medication adjustments may be necessary.
  • Hormonal effects are reported, including decreases or increases in levels of luteinizing hormone, progesterone, estradiol, thyroid hormone (T4 and T3), growth hormone, prolactin, cortisol, oxytocin and vasopressin. Gynecomastia (increased breast size) has been reported in men, as well as decreased sperm count (both which resolved with cessation of melatonin). Decreased sperm motility has been reported in rats and humans.
  • Mild gastrointestinal distress commonly occurs, including nausea, vomiting, or cramping. Melatonin has been linked to a case of autoimmune hepatitis and with triggering of Crohn's disease symptoms.
  • It has been theorized that high doses of melatonin may increase intraocular pressure and the risk of glaucoma, age-related maculopathy and myopia, or retinal damage. However, there is preliminary evidence that melatonin may actually decrease intraocular pressure in the eye, and it has been suggested as a possible therapy for glaucoma. Patients with glaucoma taking melatonin should be monitored by a healthcare professional.

Pregnancy and Breastfeeding

  • Melatonin supplementation should be avoided in women who are pregnant or attempting to become pregnant, based on possible hormonal effects. High levels of melatonin during pregnancy may increase the risk of developmental disorders. In animal studies, melatonin is detected in breast milk and therefore should be avoided during breastfeeding. In men, decreased sperm motility and decreased sperm count are reported with use of melatonin.

Interactions

Most herbs and supplements have not been thoroughly tested for interactions with other herbs, supplements, drugs, or foods. The interactions listed below are based on reports in scientific publications, laboratory experiments, or traditional use. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare professional before starting a new therapy.

Interactions with Drugs

  • Melatonin is broken down (metabolized) in the body by liver enzymes. As a result, drugs that alter the activity of these enzymes may increase or decrease the effects of melatonin supplements.
  • Increased daytime drowsiness is reported when melatonin is used at the same time as the prescription sleep-aid zolpidem (Ambien®), although it is not clear that effects are greater than with the use of zolpidem alone. In theory, based on possible risk of daytime sleepiness, melatonin may increase the amount of drowsiness caused by some other drugs, for example benzodiazepines such as lorazepam (Ativan®) or diazepam (Valium®), barbiturates such as phenobarbital, narcotics such as codeine, some antidepressants, and alcohol. Caution is advised while driving or operating machinery.
  • Based on preliminary evidence, melatonin should be avoided in patients taking the blood-thinning medication warfarin (Coumadin®), and possibly in patients using other blood-thinners (anticoagulants) such as aspirin or heparin.
  • Multiple drugs are reported to lower natural levels of melatonin in the body. It is not clear that there are any health hazards of lowered melatonin levels, or if replacing melatonin with supplements is beneficial. Examples of drugs that may reduce production or secretion of melatonin include non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Motrin®, Advil®) or naproxen (Naprosyn®, Aleve®); beta-blocker blood pressure medications such as atenolol (Tenormin®) or metoprolol (Lopressor®, Toprol®); and medications that reduce levels of vitamin B6 in the body (such as oral contraceptives, hormone replacement therapy, loop diuretics, hydralazine, theophylline). Other agents that may alter synthesis or release of melatonin include diazepam, vitamin B12, verapamil, temazepam, and somatostatin.
  • Based on preliminary evidence, melatonin should be avoided in patients taking anti-seizure medications. It has been suggested that melatonin may lower seizure threshold and increase the risk of seizure. However, multiple other studies actually report reduced incidence of seizure with regular melatonin use. This remains an area of controversy. Patients with seizure disorder taking melatonin should be monitored closely by a healthcare professional.
  • Melatonin may increase or decrease blood pressure; study results conflict. Therefore it may interact with heart or blood pressure medications making close monitoring necessary.
  • It is not clear if caffeine alters the effects of melatonin supplements in humans. Caffeine is reported to raise natural melatonin levels in the body, possibly due to effects on liver enzymes. However, caffeine may also alter circadian rhythms in the body, with effects on melatonin secretion.
  • Elevated blood sugar levels (hyperglycemia) have been reported in patients with type 1 diabetes (insulin-dependent diabetes), and low doses of melatonin have reduced glucose tolerance and insulin sensitivity. Caution is advised in patients taking drugs for diabetes by mouth or insulin. Serum glucose levels may need to be monitored by a healthcare provider, and medication adjustments may be necessary.
  • Alcohol consumption seems to affect melatonin secretion at night.
  • Preliminary reports suggest that melatonin may aid in reversing symptoms of tardive dyskinesia associated with haloperidol use.
  • Based on preliminary evidence, melatonin may increase the effects of isoniazid against Mycobacterium tuberculosis.
  • Based on animal research, melatonin may increase the adverse effects of methamphetamine on the nervous system.
  • Based on laboratory study, melatonin may increase the neuromuscular blocking effect of the muscle relaxant succinylcholine, but not vecuronium.

Interactions with Herbs & Dietary Supplements

  • Melatonin may increase daytime sleepiness or sedation when taken with herbs or supplements that may cause sedation.
  • Elevated blood sugar levels (hyperglycemia) have been reported in patients with type 1 diabetes (insulin-dependent diabetes), and low doses of melatonin have reduced glucose tolerance and insulin sensitivity. Caution is advised when using herbs or supplements that may also raise blood sugar levels, such as arginine, cocoa, DHEA, and ephedra (when combined with caffeine).
  • Based on preliminary evidence of an interaction with the blood thinning drug warfarin, and isolated reports of minor bleeding, melatonin may increase the risk of bleeding when taken with herbs and supplements that are believed to increase the risk of bleeding.
  • It is not clear if caffeine alters the effects of melatonin supplements in humans. Caffeine is reported to raise natural melatonin levels in the body, possibly due to effects on liver enzymes. However, caffeine may also alter circadian rhythms in the body, with effects on melatonin secretion.
  • Chasteberry (Vitex agnus-castus) may increase natural secretion of melatonin in the body, based on preliminary research.
  • In animal study, DHEA and melatonin have been noted to stimulate immune function, with slight additive effects when used together. Effects of this combination in humans are not clear.
  • Based on animal study, a combination of echinacea and melatonin may reduce immune function. Effects of this combination in humans are not clear.
  • Severe folate deficiency may reduce the body's natural levels of melatonin, based on preliminary study.

Authors

  • This information is based on a professional level monograph edited and peer-reviewed by contributors to the Natural Standard Research Collaboration (www.naturalstandard.com).

Selected References

Natural Standard developed the above evidence-based information based on a systematic review of the available scientific articles. For comprehensive information about alternative and complementary therapies on the professional level, go to www.naturalstandard.com. Selected references are listed below.

  1. Arendt J, Aldhous M, Wright J. Synchronisation of a disturbed sleep-wake cycle in a blind man by melatonin treatment. Lancet 4-2-1988;1(8588):772-773.
  2. Almeida Montes LG, Ontiveros Uribe MP, Cortes Sotres J, et al. Treatment of primary insomnia with melatonin: a double-blind, placebo-controlled, crossover study. J Psychiatry Neurosci. 2003;28(3):191-196.
  3. Andrade C, Srihari BS, Reddy KP, et al. Melatonin in medically ill patients with insomnia: a double-blind, placebo-controlled study. J Clin Psychiatry 2001;62(1):41-45.
  4. Campos FL, Silva-Junior FP, de Bruin VM, et al. Melatonin improves sleep in asthma: a randomized, double-blind, placebo-controlled study. Am.J.Respir.Crit Care Med. 11-1-2004;170(9):947-951.
  5. Coppola G, Iervolino G, Mastrosimone M, et al. Melatonin in wake-sleep disorders in children, adolescents and young adults with mental retardation with or without epilepsy: a double-blind, cross-over, placebo-controlled trial. Brain Dev. 2004 Sep;26(6):373-6.
  6. Dowling GA, Mastick J, Colling E, et al. Melatonin for sleep disturbances in Parkinson's disease. Sleep Med. 2005 Sep;6(5):459-66.
  7. Gupta M, Gupta YK, Agarwal S, et al. A randomized, double-blind, placebo controlled trial of melatonin add-on therapy in epileptic children on valproate monotherapy: effect on glutathione peroxidase and glutathione reductase enzymes. Br J Clin Pharmacol. 2004 Nov;58(5):542-7.
  8. Lewy AJ, Lefler BJ, Emens JS, et al. The circadian basis of winter depression. Proc Natl Acad Sci U S A. 2006 May 9;103(19):7414-9.
  9. Lu WZ, Gwee KA, Moochhalla S, et al. Melatonin improves bowel symptoms in female patients with irritable bowel syndrome: a double-blind placebo-controlled study. Aliment Pharmacol Ther. 2005 Nov 15;22(10):927-34.
  10. Peres MF, Zukerman E, da Cunha Tanuri F, et al. Melatonin, 3 mg, is effective for migraine prevention. Neurology. 2004 Aug 24;63(4):757.
  11. Samarkandi A, Naguib M, Riad W, et al. Melatonin vs. midazolam premedication in children: a double-blind, placebo-controlled study. Eur J Anaesthesiol. 2005 Mar;22(3):189-96.
  12. Shamir E, Barak Y, Shalman I, et al. Melatonin treatment for tardive dyskinesia: a double-blind, placebo- controlled, crossover study. Arch Gen.Psychiatry 2001;58(11):1049-1052.
  13. Shamir EZ, Barak Y, Shalman I, et al. Melatonin treatment for tardive dyskinesia: a double-blind, placebo-controlled, cross-over study. Annual Meeting of the American Psychiatric Association, May 5-10 2001.
  14. Weiss MD, Wasdell MB, Bomben MM, et al. Sleep hygiene and melatonin treatment for children and adolescents with ADHD and initial insomnia. J Am Acad Child Adolesc Psychiatry. 2006 May;45(5):512-9.
  15. Zemlan FP, Mulchahey JJ, Scharf MB, et al. The efficacy and safety of the melatonin agonist beta-methyl-6-chloromelatonin in primary insomnia: a randomized, placebo-controlled, crossover clinical trial. J Clin Psychiatry. 2005 Mar;66(3):384-90.
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