OBJECTIVE: To determine the degree to which zolpidem 10 mg would reduce the sleep disruption associated with rapid, eastward transatlantic travel. BACKGROUND: Subsequent to rapid transmeridian travel, individuals often complain of jet lag which includes transient disturbances in sleep patterns, alertness, appetite and mood. Disturbed sleep and impaired alertness appear to be the most debilitating symptoms of jet lag. METHODS: This multi-center, double-blind randomized, placebo-controlled, parallel-groups study involved 138 adult (mean age 44.9 years) experienced travelers while on their regular eastward transatlantic assignments originating in the US and crossing 5-9 time zones. Subjects were normal sleepers when not traveling and had to have traveled overseas at least twice during the last 24 months. Subjects were randomized to zolpidem 10 mg or placebo for three (optionally four) consecutive nights starting with the first nighttime sleep after travel. Sleep was assessed with daily questionnaires. RESULTS: A total of 130 subjects completed the study. Compared to placebo, zolpidem was associated with significantly improved sleep (statistically significant differences at nights indicated) longer total sleep time (night 1), reduced number of awakenings (nights 1 and 2), and improved sleep quality (nights 1, 2 and 3). Zolpidem was not associated with improvement in sleep latency. No unexpected or serious adverse events were reported and the most common adverse event was headache in both groups (9.2 and 17.6% for placebo and zolpidem, respectively). CONCLUSION: In seasoned travelers, zolpidem 10 mg produced significant improvement in sleep following rapid transmeridian travel.
RCT Entities:
OBJECTIVE: To determine the degree to which zolpidem 10 mg would reduce the sleep disruption associated with rapid, eastward transatlantic travel. BACKGROUND: Subsequent to rapid transmeridian travel, individuals often complain of jet lag which includes transient disturbances in sleep patterns, alertness, appetite and mood. Disturbed sleep and impaired alertness appear to be the most debilitating symptoms of jet lag. METHODS: This multi-center, double-blind randomized, placebo-controlled, parallel-groups study involved 138 adult (mean age 44.9 years) experienced travelers while on their regular eastward transatlantic assignments originating in the US and crossing 5-9 time zones. Subjects were normal sleepers when not traveling and had to have traveled overseas at least twice during the last 24 months. Subjects were randomized to zolpidem 10 mg or placebo for three (optionally four) consecutive nights starting with the first nighttime sleep after travel. Sleep was assessed with daily questionnaires. RESULTS: A total of 130 subjects completed the study. Compared to placebo, zolpidem was associated with significantly improved sleep (statistically significant differences at nights indicated) longer total sleep time (night 1), reduced number of awakenings (nights 1 and 2), and improved sleep quality (nights 1, 2 and 3). Zolpidem was not associated with improvement in sleep latency. No unexpected or serious adverse events were reported and the most common adverse event was headache in both groups (9.2 and 17.6% for placebo and zolpidem, respectively). CONCLUSION: In seasoned travelers, zolpidem 10 mg produced significant improvement in sleep following rapid transmeridian travel.
Authors: Jay S Balachandran; Carey C Thomson; Dezmond B Sumter; Anita V Shelgikar; Philippe Lachapelle; Sushmita Pamidi; Michael Fall; Chitra Lal; Ridhwan Y Baba; Neomi Shah; Barry G Fields; Kathleen Sarmiento; Matthew P Butler; Steven A Shea; Janelle V Baptiste; Katherine M Sharkey; Tisha Wang Journal: Ann Am Thorac Soc Date: 2016-04
Authors: Gary S Richardson; Phyllis C Zee; Sherry Wang-Weigand; Laura Rodriguez; Xuejun Peng Journal: J Clin Sleep Med Date: 2008-10-15 Impact factor: 4.062