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

Abstract

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.

Increased and Mistimed Sex Hormone Production in Night Shift Workers

“…Melatonin may modulate sex hormone production, downregulating the hypothalamus-pituitary-gonadal axis and possibly inhibiting aromatase, an enzyme that transforms androgens into estrogens (17,40). At high levels exogenous melatonin reduces estrogen, androgen, and gonadotropins, as demonstrated by some, but not all, clinical trials (41)(42)(43)(44)(45). We found no association between endogenous 24-hour urinary levels of aMT6s and a range of steroid hormones and metabolites.…”

Light Exposure at Night, Urinary 6-Sulfatoxymelatonin, and Serum Estrogens and Androgens in Postmenopausal Japanese Women

“…Serum estradiol level was decreased in one study (20) but not in another study (21) after 6 months of melatonin treatment with comparable doses.…”

Investigation of biochemical factors related to non-bothersome nocturnal urination

“…The parameters of the IPSS did not differ between the subjects with and without bothersome nocturnal urination because their lower urinary tract symptoms were controlled by medication, suggesting that the main cause of the increased scores of the IPSS and the QOL in subjects with bothersome nocturnal urination was nocturia itself. mean ± SD, ***: p < 0.001 *** day) for up to 6 months was reported to improve sleep quality and decrease the sleep onset latency in patients with insomnia (11). In addition to melatonin, hypnotics are reported to be useful for treating nocturia (7,16).…”