TY - JOUR
T1 - Repeated melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers
T2 - A randomized controlled trial
AU - Scheer, Frank A.J.L.
AU - Morris, Christopher J.
AU - Garcia, Joanna I.
AU - Smales, Carolina
AU - Kelly, Erin E.
AU - Marks, Jenny
AU - Malhotra, Atul
AU - Shea, Steven A.
PY - 2012/10/1
Y1 - 2012/10/1
N2 - Study Objectives: In the United States alone, approximately 22 million people take beta-blockers chronically. These medications suppress endogenous nighttime melatonin secretion, which may explain a reported side effect of insomnia. Therefore, we tested whether nightly melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers. Design: Randomized, double-blind, placebo-controlled, parallel-group design. Setting: Clinical and Translational Research Center at Brigham and Women's Hospital, Boston. Patients: Sixteen hypertensive patients (age 45-64 yr; 9 women) treated with the beta-blockers atenolol or metoprolol. Interventions: Two 4-day in-laboratory admissions including polysomnographically recorded sleep. After the baseline assessment during the first admission, patients were randomized to 2.5 mg melatonin or placebo (nightly for 3 weeks), after which sleep was assessed again during the second 4-day admission. Baseline-adjusted values are reported. One patient was removed from analysis because of an unstable dose of prescription medication. Measurements and Results: In comparison with placebo, 3 weeks of melatonin supplementation significantly increased total sleep time (+36 min; P = 0.046), increased sleep efficiency (+7.6%; P = 0.046), and decreased sleep onset latency to Stage 2 (-14 min; P = 0.001) as assessed by polysomnography. Compared with placebo, melatonin significantly increased Stage 2 sleep (+41 min; P = 0.037) but did not significantly change the durations of other sleep stages. The sleep onset latency remained significantly shortened on the night after discontinuation of melatonin administration (-25 min; P = 0.001), suggesting a carryover effect. Conclusion: In hypertensive patients treated with beta-blockers, 3 weeks of nightly melatonin supplementation significantly improved sleep quality, without apparent tolerance and without rebound sleep disturbance during withdrawal of melatonin supplementation (in fact, a positive carryover effect was demonstrated). These findings may assist in developing countermeasures against sleep disturbances associated with beta-blocker therapy. Clinical Trial Information: This study is registered with ClinicalTrials.gov, identifier: NCT00238108; trial name: Melatonin Supplements for Improving Sleep in Individuals with Hypertension; URL: http://www. clinicaltrials.gov/ct2/show/NCT00238108.
AB - Study Objectives: In the United States alone, approximately 22 million people take beta-blockers chronically. These medications suppress endogenous nighttime melatonin secretion, which may explain a reported side effect of insomnia. Therefore, we tested whether nightly melatonin supplementation improves sleep in hypertensive patients treated with beta-blockers. Design: Randomized, double-blind, placebo-controlled, parallel-group design. Setting: Clinical and Translational Research Center at Brigham and Women's Hospital, Boston. Patients: Sixteen hypertensive patients (age 45-64 yr; 9 women) treated with the beta-blockers atenolol or metoprolol. Interventions: Two 4-day in-laboratory admissions including polysomnographically recorded sleep. After the baseline assessment during the first admission, patients were randomized to 2.5 mg melatonin or placebo (nightly for 3 weeks), after which sleep was assessed again during the second 4-day admission. Baseline-adjusted values are reported. One patient was removed from analysis because of an unstable dose of prescription medication. Measurements and Results: In comparison with placebo, 3 weeks of melatonin supplementation significantly increased total sleep time (+36 min; P = 0.046), increased sleep efficiency (+7.6%; P = 0.046), and decreased sleep onset latency to Stage 2 (-14 min; P = 0.001) as assessed by polysomnography. Compared with placebo, melatonin significantly increased Stage 2 sleep (+41 min; P = 0.037) but did not significantly change the durations of other sleep stages. The sleep onset latency remained significantly shortened on the night after discontinuation of melatonin administration (-25 min; P = 0.001), suggesting a carryover effect. Conclusion: In hypertensive patients treated with beta-blockers, 3 weeks of nightly melatonin supplementation significantly improved sleep quality, without apparent tolerance and without rebound sleep disturbance during withdrawal of melatonin supplementation (in fact, a positive carryover effect was demonstrated). These findings may assist in developing countermeasures against sleep disturbances associated with beta-blocker therapy. Clinical Trial Information: This study is registered with ClinicalTrials.gov, identifier: NCT00238108; trial name: Melatonin Supplements for Improving Sleep in Individuals with Hypertension; URL: http://www. clinicaltrials.gov/ct2/show/NCT00238108.
KW - Actigraphy
KW - Adrenergic beta-antagonists
KW - Atenolol
KW - Autonomic nervous system
KW - Hypertension
KW - Hypnotics
KW - Melatonin
KW - Metoprolol
KW - Polysomnography
KW - Sleep
UR - http://www.scopus.com/inward/record.url?scp=84867055019&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84867055019&partnerID=8YFLogxK
U2 - 10.5665/sleep.2122
DO - 10.5665/sleep.2122
M3 - Article
C2 - 23024438
AN - SCOPUS:84867055019
SN - 0161-8105
VL - 35
SP - 1395
EP - 1402
JO - Sleep
JF - Sleep
IS - 10
ER -