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PIII‐38
Author(s) -
Richardson G. S.,
WangWeigand S.,
Sainati S.,
Demissie S.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.246
Subject(s) - prolactin , placebo , endocrine system , medicine , endocrinology , insomnia , thyroid function , hormone , pharmacology , alternative medicine , pathology
BACKGROUND Ramelteon, an MT 1 /MT 2 receptor agonist developed for insomnia treatment, was evaluated for long‐term effects on endocrine function. METHODS In a double‐blind multicenter trial, 122 patients (aged 18–45 yr) with chronic insomnia received placebo or ramelteon 16 mg nightly for 6 months. Multiple endocrine variables were analyzed at baseline and monthly. RESULTS There were no consistent statistically significant differences between treatments on measures of thyroid function (total T4, free T4, TSH and total T3), adrenal function (AM cortisol and ACTH), or on most reproductive endocrine measures (LH, FSH, estradiol[women], total and free testosterone[men]). There were small, but statistically significant, differences in prolactin levels between groups: overall mean change from baseline of 2.9 μg/L (22.8% change) with ramelteon and −0.6 μg/L (4.4% change) with placebo. The effect on prolactin appeared to be transient and was only seen in women. No clinical signs of elevated prolactin were reported; average menstrual cycle length, duration of menses, and ovulation probability did not differ between groups. AE incidence was similar between groups; most AEs were mild or moderate (3 patients had SAEs unrelated to study drug). CONCLUSION Long‐term treatment of chronic insomnia with ramelteon had no appreciable effect on multiple measures of endocrine function compared to placebo. A mild, transient increase in prolactin was observed in women, but it had no significant clinical effect. Clinical Pharmacology & Therapeutics (2005) 79 , P68–P68; doi: 10.1016/j.clpt.2005.12.246