STUDY OBJECTIVES: To assess the stability of the multiple sleep latency test (MSLT) in primary insomnia and its relation to total sleep time. DESIGN: Randomized, double-blind, placebo controlled, clinical trial. SETTING: Outpatient with sleep laboratory assessments in months 1 and 8 of treatment. PARTICIPANTS: Ninety-five primary insomniacs, 32-64 years old and 55 age- and sex-matched general population-based, representative controls. INTERVENTIONS: After a screening nocturnal polysomnograms (NPSG) and MSLT the following day, participants with primary insomnia were randomized to take zolpidem 10 mg (n = 50) or placebo (n = 45) nightly for 12 months. During months 1 and 8, while taking their prescribed treatments, NPSGs and MSLTs the following day were conducted. A population-based sample served as controls and received a single NPSG followed by MSLT. RESULTS:Mean daily sleep latency on the screening MSLT of insomniacs was normally distributed across the full range of MSLT scores and significantly higher than those of a population-based representative control sample (P < 0.006). The insomniacs with the highest screening MSLTs had the shortest screening total sleep times (P < 0.05). The MSLTs of insomniacs during treatment in study month 1 were correlated (r = 0.44, P < 0.001) with their month 8 MSLT. The mean MSLT score of the zolpidem group did not differ from that of the placebo group, and the stability within treatment groups also did not differ. CONCLUSIONS: These data support the hypothesis that some insomniacs show a reliable disorder of hyperarousal with increased wake drive both at night and during the day.
RCT Entities:
STUDY OBJECTIVES: To assess the stability of the multiple sleep latency test (MSLT) in primary insomnia and its relation to total sleep time. DESIGN: Randomized, double-blind, placebo controlled, clinical trial. SETTING:Outpatient with sleep laboratory assessments in months 1 and 8 of treatment. PARTICIPANTS: Ninety-five primary insomniacs, 32-64 years old and 55 age- and sex-matched general population-based, representative controls. INTERVENTIONS: After a screening nocturnal polysomnograms (NPSG) and MSLT the following day, participants with primary insomnia were randomized to take zolpidem 10 mg (n = 50) or placebo (n = 45) nightly for 12 months. During months 1 and 8, while taking their prescribed treatments, NPSGs and MSLTs the following day were conducted. A population-based sample served as controls and received a single NPSG followed by MSLT. RESULTS: Mean daily sleep latency on the screening MSLT of insomniacs was normally distributed across the full range of MSLT scores and significantly higher than those of a population-based representative control sample (P < 0.006). The insomniacs with the highest screening MSLTs had the shortest screening total sleep times (P < 0.05). The MSLTs of insomniacs during treatment in study month 1 were correlated (r = 0.44, P < 0.001) with their month 8 MSLT. The mean MSLT score of the zolpidem group did not differ from that of the placebo group, and the stability within treatment groups also did not differ. CONCLUSIONS: These data support the hypothesis that some insomniacs show a reliable disorder of hyperarousal with increased wake drive both at night and during the day.
Authors: Eric A Nofzinger; Daniel J Buysse; Anne Germain; Julie C Price; Jean M Miewald; David J Kupfer Journal: Am J Psychiatry Date: 2004-11 Impact factor: 18.112
Authors: A N Vgontzas; E O Bixler; H M Lin; P Prolo; G Mastorakos; A Vela-Bueno; A Kales; G P Chrousos Journal: J Clin Endocrinol Metab Date: 2001-08 Impact factor: 5.958
Authors: Nathaniel F Watson; Kathryn Paige Harden; Dedra Buchwald; Michael V Vitiello; Allan I Pack; Eric Strachan; Jack Goldberg Journal: Sleep Date: 2014-02-01 Impact factor: 5.849
Authors: Vivek Pillai; Thomas Roth; Timothy Roehrs; Kenneth Moss; Edward L Peterson; Christopher L Drake Journal: Sleep Date: 2017-02-01 Impact factor: 5.849
Authors: David A Kalmbach; Daniel J Buysse; Philip Cheng; Thomas Roth; Alexander Yang; Christopher L Drake Journal: Sleep Med Date: 2019-11-14 Impact factor: 3.492