Insomnia<unk>  is approved for the treatment of insomnia characterized by difficulty with sleep onset in adults. In regulatory clinical trials, it was found to significantly reduce latency to persistent sleep (LPS). A 2009 pooled analysis of four clinical trials found that<unk>  at a dose of 8 mg reduced sleep onset by 13 minutes (30% decrease) relative to placebo on the first and second nights of use. Subsequent meta-analyses of longer-duration use have found that<unk>  decreases subjective sleep latency by about 4 to 7 minutes. Meta-analyses are mixed on whether<unk>  increases total sleep time.<unk>  also improves sleep quality ( –0.074, 95% –0.13 to –0.02) and sleep efficiency. The clinical improvement in insomnia with<unk>  is small and of questionable benefit.<unk>  is approved in the United States but was not approved in the European Union owing to concerns that it lacked effectiveness. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) noted that<unk>  had only been found to improve sleep onset and not other sleep outcomes, only one of three clinical trials actually found that it improved sleep onset, and that the improvement in sleep onset was too small to be clinically meaningful. The CHMP also noted that the long-term effectiveness of<unk>  had not been demonstrated. The American Academy of Sleep Medicine's 2017 clinical practice guidelines recommended the use of<unk>  in the treatment of sleep-onset insomnia. It rated the recommendation as weak and the quality of evidence as very low but concluded that the potential benefits outweighed the potential harms. The guidelines found that<unk>  reduces sleep latency by 9minutes (95% 6–12minutes) but does not improve sleep quality. In contrast to<unk> , the guidelines did not recommend the use of melatonin. Circadian rhythm sleep disorders Melatonin receptor agonists like melatonin and tasimelteon are considered to be effective in regulating sleep–wake cycles and in the treatment of circadian rhythm sleep disorders like delayed sleep phase disorder.<unk>  has been assessed in only a few studies in the treatment of circadian rhythm sleep disorders, including jet lag disorder, shift work disorder, and non-24-hour sleep–wake disorder. These studies have been of varying quality and their findings in terms of effectiveness have been mixed.<unk>  is approved only for treatment of insomnia and is not approved for treatment of circadian rhythm sleep disorders. It was previously under development for treatment of circadian rhythm sleep disorders, but development for these indications was discontinued. Other uses Delirium A systematic review, published in 2014, concluded<unk>  was found to be beneficial in preventing delirium in medically ill individuals when compared to placebo." A 2022 systematic review and meta-analysis found that the combination of<unk>  and the orexin receptor antagonist suvorexant may reduce the incidence of delirium in adults hospitalized patients whereas suvorexant alone was ineffective. Bipolar disorder<unk>  has received attention in psychiatry as a possible add-on treatment for mania in bipolar disorder. However, to date, the scarce available evidence fails to support the clinical utility of<unk>  and other melatonin receptor agonists such as melatonin for mania. Available forms<unk>  is available in the form of 8 mg oral film-coated tablets.
Ramelteon
Enarodustat
Elixir
Miglustat
Snoezelen
Ecallantide
Patisiran
Zileuton