Melatonin may improve sleep in people with autism. Another review from 2017 put this decrease at six minutes to sleep onset but found no difference in total sleep time. A review from 2017 found a modest effect on time until onset of sleep. A review by the Agency for Healthcare Research and Quality (AHRQ) from 2015 stated that evidence of benefit in the general population was unclear.
Positions on the benefits of melatonin for insomnia are mixed. It is deemed to be a first-line agent for short-term treatment of insomnia in people 55 years old or older. It is also indicated for the short-term treatment of primary insomnia characterized by poor quality of sleep in people who are aged 55 or over. Some studies have shown melatonin to reduce the time until onset of sleep and increase sleep duration in children with neurodevelopmental disorders. In the European Union, prolonged-release melatonin (Circadin) is indicated for the treatment of insomnia in children and adolescents age 2 to 18 with autism spectrum disorder (ASD) and Smith–Magenis syndrome, in whom sleep hygiene measures have been insufficient. In 2020, it was the 298th most commonly prescribed medication in the United States, with more than 1 million prescriptions. Besides melatonin, certain synthetic melatonin receptor agonists like ramelteon, tasimelteon, and agomelatine are also used in medicine. It was approved for medical use in the European Union in 2007. The US Food and Drug Administration (FDA) treats melatonin as a dietary supplement and as such has not approved it for any medical uses. In the European Union, it is indicated for the treatment of insomnia in children and adolescents. In Australia and the European Union, it is indicated for difficulty sleeping in people over the age of 54. It is sold over the counter in Canada and the United States in the United Kingdom, it is a prescription-only medication. Prolonged-release melatonin used as a medication has a half-life of 3.5 to 4 hours. Immediate-release melatonin has a short elimination half-life of about 20 to 50 minutes. It is thought to activate these receptors in the suprachiasmatic nucleus of the hypothalamus in the brain to regulate the circadian clock and sleep–wake cycles. Melatonin acts as an agonist of the melatonin MT 1 and MT 2 receptors, the biological targets of endogenous melatonin. Its use is not recommended during pregnancy or breastfeeding or for those with liver disease. They may include somnolence (sleepiness), headaches, nausea, diarrhea, abnormal dreams, irritability, nervousness, restlessness, insomnia, anxiety, migraine, lethargy, psychomotor hyperactivity, dizziness, hypertension, abdominal pain, heartburn, mouth ulcers, dry mouth, hyperbilirubinaemia, dermatitis, night sweats, pruritus, rash, dry skin, pain in the extremities, symptoms of menopause, chest pain, glycosuria (sugar in the urine), proteinuria (protein in the urine), abnormal liver function tests, increased weight, tiredness, mood swings, aggression and feeling hungover. Side effects of melatonin are rare but may occur in 1 to 10 patients in 1,000. Side effects from melatonin supplements are minimal at low doses for short durations (in the studies reported about equally for both melatonin and placebo). A prolonged-release form of melatonin is also approved for use as a medication in Europe for the treatment of insomnia in certain people. A 2017 review found that sleep onset occurred six minutes faster with use, but found no change in total time asleep. Evidence of its benefit for this use, however, is not strong. As a supplement, it is often used for the short-term treatment of insomnia, such as from jet lag or shift work, and is typically taken orally.
As a hormone, melatonin is released by the pineal gland and is involved in sleep–wake cycles. Melatonin is a dietary supplement and medication as well as naturally occurring hormone.
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