Buy Ramelteon (Rozerem) Cas 196597-26-9

Buy Ramelteon (Rozerem) Cas 196597-26-9

Ramelteon, sold under the brand name Rozerem among others, is a melatonin agonist medication which is used in the treatment of insomnia.^[3][5] It is indicated specifically for the treatment of insomnia characterized by difficulties with sleep onset.^[3] It reduces the time taken to fall asleep, but the degree of clinical benefit is small.^[6] The medication is approved for long-term use.^[3] Ramelteon is taken by mouth.^[3]

Side effects of ramelteon include somnolence, dizziness, fatigue, nausea, exacerbated insomnia, and changes in hormone levels.^[3] Ramelteon is an analogue of melatonin and is a selective agonist of the melatonin MT₁ and MT₂ receptors.^[3] The half-life and duration of ramelteon are much longer than those of melatonin.^[7] Ramelteon is not a benzodiazepine or Z-drug and does not interact with GABA receptors, instead having a distinct mechanism of action.^[3][8]

Ramelteon was first described in 2002^[9] and was approved for medical use in 2005.^[10] Unlike certain other sleep medications, ramelteon is not a controlled substance in nearly every country and has no known potential for misuse.^[3]

Ramelteon is approved for the treatment of insomnia characterized by difficulty with sleep onset in adults.^[3][5] In regulatory clinical trials, it was found to significantly reduce latency to persistent sleep (LPS).^[3] A 2009 pooled analysis of four clinical trials found that ramelteon 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.^[11] Subsequent meta-analyses of longer-duration use have found that ramelteon decreases subjective sleep latency by about 4 to 7 minutes.^[6][12] Meta-analyses are mixed on whether ramelteon increases total sleep time.^[12][6] Ramelteon also improves sleep quality (SMDTooltip standardized mean difference –0.074, 95% CITooltip confidence interval –0.13 to –0.02) and sleep efficiency.^[6] The clinical improvement in insomnia with ramelteon is small and of questionable benefit.^[6][8]

Ramelteon is approved in the United States but was not approved in the European Union owing to concerns that it lacked effectiveness.^[8] The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) noted that ramelteon 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.^[8] The CHMP also noted that the long-term effectiveness of ramelteon had not been demonstrated.^[8]

The American Academy of Sleep Medicine‘s 2017 clinical practice guidelines recommended the use of ramelteon in the treatment of sleep-onset insomnia.^[13] It rated the recommendation as weak and the quality of evidence as very low but concluded that the potential benefits outweighed the potential harms.^[13] The guidelines found that ramelteon reduces sleep latency by 9 minutes (95% CITooltip confidence interval 6–12 minutes) but does not improve sleep quality.^[13] In contrast to ramelteon, the guidelines did not recommend the use of melatonin.^[13]

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.^[14][15] Ramelteon 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.^[14] These studies have been of varying quality and their findings in terms of effectiveness have been mixed.^[14] Ramelteon is approved only for treatment of insomnia and is not approved for treatment of circadian rhythm sleep disorders.^[14][16] It was previously under development for treatment of circadian rhythm sleep disorders, but development for these indications was discontinued.^[16]

Some clinical trials since 2020 have found that dosages much lower than the standard 8 mg tablet may be more effective at advancing the circadian rhythm.^[17][18][19]