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Insomnia related to postmenopausal syndrome and hormone replacement therapy: sleep laboratory studies on baseline differences between patients and controls and double-blind, placebo-controlled investigations on the effects of a novel estrogen-progestogen combination (Climodien, Lafamme) versus estrogen alone.

Differences in sleep and awakening quality between 51 insomniac postmenopausal syndrome patients and normal controls were evaluated. In a subsequent double-blind, placebo-controlled, comparative, randomized, three-arm trial (Climodien 2/3 = estradiol valerate 2 mg + the progestogen dienogest 3 mg = regimen A, estradiol valerate 2 mg = regimen EV, and placebo = regimen P), the effects of 2 months of hormone replacement therapy were investigated, followed by a 2-month open-label phase in which all patients received Climodien 2/2 (EV 2 mg + dienogest 2 mg = regimen A*). Polysomnography at baseline demonstrated significantly deteriorated sleep initiation and maintenance, increased S1 and decreased S2 in patients. Subjective sleep and awakening quality, well-being, morning drive, wakefulness, memory and reaction time performance were deteriorated too. Treatment with both regimen A and regimen EV induced a moderate, although nonsignificant, improvement in the primary efficacy variable wakefulness during the total sleep period compared with baseline, while under placebo no changes occurred. Secondary efficacy variables concerning sleep initiation and maintenance, and sleep architecture showed similar findings. The apnea and apnea-hypopnea indices improved significantly under regimen A, compared with both baseline and placebo. Subjective sleep and awakening quality improved significantly after regimen A and EV compared with baseline, with the drug-induced changes being superior to those induced by placebo. In the open-label phase, subjective sleep quality improved further, significantly in the former regimen A group. Awakening quality, somatic complaints and morning thymopsyche did not yield any significant findings. Concerning morning noopsychic performance, memory improved significantly after regimen A compared with baseline, fine motor activity after regimen EV. Reaction time performance increased with all three compounds. In conclusion, Climodien significantly improved subjective sleep quality, the apnea and apnea-hypopnea indices of insomniac postmenopausal syndrome patients, while it only marginally improved variables concerning objective sleep and awakening quality.

Aged↗

Relationship disturbances and parent-child therapy. Sleep problems.

This article has attempted to establish the importance of considering behavioral disturbances in infancy and early childhood as disturbances of the parent-child relationship. When the psychologic and mental mechanisms of the individual infant are too immature to sustain disturbed behavior across several settings and when the behavioral disturbance seems to be specific to a particular relationship, it is more appropriate to diagnose the pathology as being in the relationship. The article has offered a diagnostic framework of relationship pathology that spans the spectrum from normal variation (relationship perturbation) to relationship behaviors that are at risk of becoming a disorder (relationship disturbance) to significant relationship disorders that most likely require a professional intervention. A multiaxial assessment protocol is recommended that evaluates primary relationships (Axis I), parent-infant interaction styles (Axis II), the parent and infant as individuals (Axis III), and more distal contextual factors that affect the relationship (Axis IV). Sleep disturbances in infancy have been used as an example to demonstrate the spectrum of relationship pathology. Additional research is needed to develop more precise, age-relevant cut points for the spectrum of relationship pathology for sleep problems and for other parent-infant relationship disturbances in the areas of feeding, excessive crying, and limit setting or tantrums. More research is also needed to define better when and how relationship pathology becomes transformed into individual pathology and how early intervention may alter the course of this trajectory.

Adolescent↗

[Melatonin: is there a rationale for the clinical use of this hormone in sleep therapy?].

Melatonin, the hormone of the pineal gland, is under discussion as multipotent hormone for different indications. The question whether there is a therapeutical benefit for all these indications could not be evaluated, because more clinical studies are needed. Based on the data of basic research as well as first clinical experience, the use of melatonin to treat sleep disorders caused by a deficit of melatonin might be appropriate. Other indications, derived from animal studies where the results often could not be applied to humans, have still to be proved. Given the fact that melatonin is not an approved product, only an intent to treat approach is allowed where it might by useful to document the melatonin deficit and to use a selected and certificate product.

Animals↗