Insomnia related to postmenopausal syndrome: Sleep laboratory studies on differences between patients and normal controls, and influence of an estrogen-progestogen combination with dienogest versus estrogen alone and placebo

The present paper reviews two studies. In the first study, 30 patients with the ICD-10 diagnosis of insomnia (G 47.0) related to postmenopausal syndro me (N 95.1) were assessed in comparison with 16 controls. Polysomnography w as used to quantify objective sleep quality and a psychometric test battery was used to evaluate subjective sleep and awakening quality, as well as mo rning thymopsychic and noopsychic variables. Patients showed a significantl y lengthened sleep latency, increased nocturnal wakefulness and awakenings, reduced total sleep time and sleep efficiency, increased drowsiness stages S1 and stage shifts, as well as decreased S2. Subjective sleep quality was also reduced, but awakening quality and thymopsychic variables were not. I n contrast, the noopsyche showed a deterioration of memory, fine motor acti vity, reaction time and reaction time variability, as well as increased err ors of omission and commission in the reaction test. In a subsequent study, the efficacy of a combined estrogen-progestogen regimen on sleep and awake ning quality in 55 insomniac postmenopausal patients was investigated in a 2-month double-blind, placebo-controlled, comparative, randomized, 3-arm tr ial phase (regimen A: estradiol valerate 2 mg + dienogest 3 mg; regimen EV: estradiol valerate 2 mg; regimen P: placebo). This was followed by a 2-mon th open-label phase in which all patients received estradiol valerate 2 mg + dienogest 2 mg as regimen A* (Climodien(R) or Lafamme(R)). Polysomnograph y demonstrated a moderate though nonsignificant improvement in the primary efficacy variable wakefulness during the total sleep period with both regim en A and regimen EV compared with baseline, while under placebo only minima l changes were observed. Secondary efficacy variables concerning sleep init iation and maintenance and sleep architecture showed similar findings. Resp iratory variables, such as the apnea and apnea-hypopnea indices, showed a s ignificant improvement under regimen A, compared with both baseline and pla cebo. Subjective sleep and awakening quality improved significantly after r egimen A and estradiol valerate compared with baseline, with the drug-induc ed changes being superior to those induced by placebo. In the open-label ph ase, subjective sleep quality improved further, significantly in the former regimen A group. Awakening quality, somatic complaints and thymopsychic va riables in the morning did not yield any significant findings. Numerical me mory improved significantly after regimen A compared with baseline, fine mo tor activity improved with regimen EV and reaction time task performance wi th all three compounds. In conclusion, the studied estrogen/progestogen com binations with dienogest significantly ameliorated subjective sleep quality and sleep-related breathing disorders of patients with insomnia related to a postmenopausal syndrome, while it only marginally improved variables con cerning objective sleep and awakening quality. (C) 2001 Prous Science. All rights reserved.