Lack of changes in serum prolactin, FSH, TSH, and estradiol after melatonin treatment in doses that improve sleep and reduce benzodiazepine consumption in sleep-disturbed, middle-aged, and elderly patients.



J Pineal Res 2001 Jan;30(1):34-42
Siegrist C, Benedetti C, Orlando A, Beltran JM, Tuchscherr L, Noseda CM, Brusco LI, Cardinali DP. Sanatorios Los Arroyos e IPAM, Rosario, Argentina.


An open pilot study on the safety and efficacy of melatonin in the treatment of insomniac patients was conducted in 22 subjects (16 females), mean +/- S.D. age 60.1 +/- 9.5 years. All patients received 3 mg of gelatin melatonin capsules per os daily for 6 months, 30 min before expected sleep time. Twenty of 22 patients were on benzodiazepine treatment and they continued this treatment for part of or for the entire melatonin administration period. Serum concentrations of prolactin, follicle-stimulating hormone (FSH), thyroid-stimulating hormone (TSH), or estradiol were measured by radioimmunoassay (RIA) in morning samples at the beginning and after 6 months of melatonin administration, and standard clinical laboratory tests for blood components were performed. Urinary 6-sulphatoxymelatonin (aMT6s) excretion was measured by RIA before treatment. Serum concentrations of prolactin, FSH, TSH, or estradiol did not exhibit changes after 6 months of melatonin administration, nor were any indications of hematologic or blood biochemistry alteration found. Melatonin augmented significantly the quality and duration of sleep, and decreased sleep latency and the number of awakening episodes, as assessed from sleep logs filled by the patients (first 21 days) and from structured interviews performed by incumbent physicians (up to 6 months). Estimates of next-day function (i.e., alertness in the morning and during the day) also improved significantly during melatonin treatment. The observed effect lasted for the entire period examined (up to 6 months), with 22 out of 22 patients showing improved sleep at the end of treatment. The urinary excretion of aMT6s before starting administration of melatonin correlated negatively and significantly with age, but not with the intensity of sleep the disorder or the outcome of treatment. In 13 of 20 patients taking benzodiazepines together with melatonin, benzodiazepine use could be stopped, and in another four patients, benzodiazepine dose could be decreased to 25-66% of the initial dose. The results of this open, subacute administration trial indicate that melatonin is a safe and useful treatment for sleep disturbances in middle-aged or elderly patients, either by itself or together with benzodiazepines.
Publication Types: Clinical trial.

In 22 soggetti insonni di età media di anni 60 la melatonina alla dose di 3 mg, somministrata 30 minuti prima di dormire per 6 mesi non indusse modificazioni della concentrazione ematica di prolattina, TSH, FSH ed estradiolo, così come quelli dei parametri bioumorali più comuni.
La qualità del sonno migliorò e la sua durata aumentò, con riduzione della latenza del sonno e degli episodi di risveglio; risultarono migliorate le funzioni e prestazioni del giorno dopo e in particolare l'attenzione. In 13 dei 20 soggetti che assumevano benzodiazepine durante il trial fu possibile ridurre la loro posologia iniziale del 25-66%; ciò testimonia l'efficacia della melatonina nel migliorare il sonno in soggetti di età media e anziani, anche in un trattamento a 6 mesi e in presenza di consuetudine ad assumere benzodiazepine. Nei soggetti studiati l'eliminazione urinaria del metabolita 6-sulfatossi-melatonina era correlato negativamente all'età. E' uno studio aperto.




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