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 duration 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 lormetazepam in elderly 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 outpatients with insomnia were randomised to receive 2 weeks of treatment with lormetazepam 0.5mg + SHT or SHT alone, followed by a 1-week observation period. Details on sleep latency, number of awakenings and freshness on awakening 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 lormetazepam 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 lormetazepam + 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 lormetazepam + 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 lormetazepam + 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 lormetazepam + SHT group: after 2 weeks, on average patients were awakening less than once per night. SSS and ESS scores also improved significantly in the lormetazepam + 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 lormetazepam group. Vital signs did not change from baseline and no adverse events were reported for either group. CONCLUSION: 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 lormetazepam when used in combination with a sleep training programme may help to maintain adherence to treatment.
RCT Entities:
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 duration 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 lormetazepam in elderly 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 outpatients with insomnia were randomised to receive 2 weeks of treatment with lormetazepam 0.5mg + SHT or SHT alone, followed by a 1-week observation period. Details on sleep latency, number of awakenings and freshness on awakening 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 lormetazepam 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 lormetazepam + 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 lormetazepam + 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 lormetazepam + 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 lormetazepam + SHT group: after 2 weeks, on average patients were awakening less than once per night. SSS and ESS scores also improved significantly in the lormetazepam + 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 lormetazepam group. Vital signs did not change from baseline and no adverse events were reported for either group. CONCLUSION: 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 lormetazepam when used in combination with a sleep training programme may help to maintain adherence to treatment.