Efficacy of Prolonged-Release Melatonin 2 mg (PRM 2 mg) Prescribed for Insomnia in Hospitalized Patients for COVID-19: A Retrospective Observational Study

Abstract

Background: we have observed the effect of insomnia treatment in clinical and prognostic differences of patients admitted for COVID-19 pneumonia in respiratory sub-intensive units that were administered a prolonged-release melatonin 2 mg (PRM 2 mg) therapy versus a group of patients out of therapy. Materials and Methods: We evaluated 40 patients on prolonged-release melatonin 2 mg (PRM 2 mg) therapy versus a control group of 40 patients out of therapy. Results: patients in the PRM 2 mg group had a shorter duration of therapy with non-invasive ventilation (5.2 ± 3.0 vs. 12.5 ± 4.2; p < 0.001), with a shorter stay in sub-intensive care (12.3 ± 3.2 vs. 20.1 ± 6.1; p < 0.001), and, therefore, a shorter overall duration of hospitalization (31.3 ± 6.8 vs. 34.3 ± 6.9 p = 0.03). In addition, a lower incidence of delirium was found (2.2 ± 1.1 vs. 3.3 ± 1.3; p < 0.001). Conclusions: A significant increase in sleep hours and a reduction in delirium episodes occurs in hospitalized insomniac patients treated with PRM 2 mg, compared to untreated patients. Based on these preliminary results, we can assume that there are benefits of prolonged-release melatonin 2 mg in COVID-19 therapy.

Mechanisms and clinical evidence to support melatonin's use in severe COVID-19 patients to lower mortality

“…In principle, melatonin should be useful in protecting against the SARS-CoV2 infection and to reduce the symptoms of COVID-19 patients. Indeed, several clinical studies have confirmed this point [6] , [7] , [8] . Most importantly, use of melatonin is one of the only treatments which may significantly reduce the mortality of severe COVID patients.…”

“…Subsequently, a number clinical trials with different end points were performed using melatonin to treat COVID-19 patients. The endpoints included improvement of the sleep, prophylactic use, shortening of the hospitalization time and others [6] , [7] , [86] , [87] . The size of these trials is small because of limited financial support since melatonin is inexpensive and non-patentable; thus, pharmaceutical companies would not support research on this molecule.…”

Effect of Melatonin in Broccoli Postharvest and Possible Melatonin Ingestion Level

“…Numerous roles have been proposed for melatonin in mammals, such as the regulator of sleep cycles [ 9 ], sexual behavior [ 10 ], endocrine rhythms [ 11 , 12 , 13 ], amongst others. More recently, its implications have been shown in glucose metabolism and insulin [ 14 , 15 , 16 ], as a sensitizer in anti-oncogenic therapies [ 17 ], its positive effects in Parkinson’s and Alzheimer’s diseases [ 18 ], and its therapeutic efficiency in COVID-19 treatment [ 19 , 20 , 21 ].…”

Unbalanced IDO1/IDO2 Endothelial Expression and Skewed Keynurenine Pathway in the Pathogenesis of COVID-19 and Post-COVID-19 Pneumonia

“…A possible role in protecting pulmonary endothelial cells can be also hypothesized, as observed in pre-eclampsia [ 273 ]. Several authors have proposed melatonin as a useful therapeutic tool in contrasting neurological complications and super-infections for both COVID-19 and PACS patients [ 274 , 275 , 276 , 277 , 278 ], and a significant vantage in mortality and recovery rate has been observed in severe cases [ 279 , 280 , 281 ]. Validation of the therapeutic role of melatonin and its metabolites in COVID-19 and PACS is needed, and clinical trials and the use of reliable animal models are warranted [ 282 , 283 , 284 , 285 , 286 , 287 ].…”