Background and objective: Sleep architecture changes with age, both in terms of efficiency and total duration of sleep,. Hypnotic benzodiazepines promote rapid onset of sleep uninterrupted sleep and longer duratio of sleep in the absence of carryover sedation the following morning; therefore, these may be appropriate for use in older patients. This study was performed to evaluate the efficacy and safety of lormetazepan in eldelrly patients with primary insomnia when used in association with sleep hygiene training (SHT). The impact of restored sleep on daily sleepiness was also investigated. Patients and methods: In this open-label study, 30 elderly outpatiens with insomnia were randomised to receive 2 weeks of treatment with of tmttmeat with lormetazepan 0.5 mg + SHT or SHT alone, followed by a 1-week observation period. Details on sleep latency, number of awakenings and freshness of awakening of were recorded by patients in a daily sleep diary. The Epworth Sleepiness Scale (ESS) and Stanford Sleepiness Scale (SSS) were used to measure daily sleepiness. Results: Addition of lormetazepan to SHT improved all sleep parameters measured compared with SHT alone. Mean duration of sleep improved significantly from baseline (mean rank = 1.00) in the lormetazepan + SHT group after 2 weeks of treatment (mean rank = 2.87; Friedmann test = 27.448; p<0.001), but declined significantly in the group receiving SHT alone (from mean rank 2.33 to 1.57; Friedmann test = 6.465; p<0.05). Mean duration of sleep increased by approximately 150 minutes each night in the lormetazepan + SHT group but decreased by more than 30 minutes in the SHT-only group. Improvement in sleep quality from baseline was statistically significant only in the lormetazepan + SHT group: for both deepness of sleep and the perception of awakening refreshed, mean scores increased from approximately 3 at baseline to approximately 8 (on a scale of 1-10) after 2 weeks in this group. Sleep latency also decreased significantly in the lormetazepan + SHT group: after 2 weeks, on average patients were awakening less than once per night. SSS and ESS scores also improved significantly in the lormetazepan + SHT group; in contrast, in the SHT-only group, the mean ESS score worsened significantly from baseline and the mean SSS score remained relatively constant. No rebound insomnia was reported during follow-up in patients in the lormetazepan group. Vital signs did not change from baseline and no adverse events were reported for either group. Conclusions: Management of insomnia in the elderly appears to have a better outcome when pharmacotherapy is combined with SHT rather than SHT alone. The earlier improvement in sleep quality with lormetazepan when used in combination with sleep training programme may help to maintain adherence to treatment.

Role of lormetazepam in the treatment of insomnia in the elderly.

DE VANNA, MAURIZIO;
2007

Abstract

Background and objective: Sleep architecture changes with age, both in terms of efficiency and total duration of sleep,. Hypnotic benzodiazepines promote rapid onset of sleep uninterrupted sleep and longer duratio of sleep in the absence of carryover sedation the following morning; therefore, these may be appropriate for use in older patients. This study was performed to evaluate the efficacy and safety of lormetazepan in eldelrly patients with primary insomnia when used in association with sleep hygiene training (SHT). The impact of restored sleep on daily sleepiness was also investigated. Patients and methods: In this open-label study, 30 elderly outpatiens with insomnia were randomised to receive 2 weeks of treatment with of tmttmeat with lormetazepan 0.5 mg + SHT or SHT alone, followed by a 1-week observation period. Details on sleep latency, number of awakenings and freshness of awakening of were recorded by patients in a daily sleep diary. The Epworth Sleepiness Scale (ESS) and Stanford Sleepiness Scale (SSS) were used to measure daily sleepiness. Results: Addition of lormetazepan to SHT improved all sleep parameters measured compared with SHT alone. Mean duration of sleep improved significantly from baseline (mean rank = 1.00) in the lormetazepan + SHT group after 2 weeks of treatment (mean rank = 2.87; Friedmann test = 27.448; p<0.001), but declined significantly in the group receiving SHT alone (from mean rank 2.33 to 1.57; Friedmann test = 6.465; p<0.05). Mean duration of sleep increased by approximately 150 minutes each night in the lormetazepan + SHT group but decreased by more than 30 minutes in the SHT-only group. Improvement in sleep quality from baseline was statistically significant only in the lormetazepan + SHT group: for both deepness of sleep and the perception of awakening refreshed, mean scores increased from approximately 3 at baseline to approximately 8 (on a scale of 1-10) after 2 weeks in this group. Sleep latency also decreased significantly in the lormetazepan + SHT group: after 2 weeks, on average patients were awakening less than once per night. SSS and ESS scores also improved significantly in the lormetazepan + SHT group; in contrast, in the SHT-only group, the mean ESS score worsened significantly from baseline and the mean SSS score remained relatively constant. No rebound insomnia was reported during follow-up in patients in the lormetazepan group. Vital signs did not change from baseline and no adverse events were reported for either group. Conclusions: Management of insomnia in the elderly appears to have a better outcome when pharmacotherapy is combined with SHT rather than SHT alone. The earlier improvement in sleep quality with lormetazepan when used in combination with sleep training programme may help to maintain adherence to treatment.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11368/1693622
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