1.Effects of zolpidem on sleep parameters in patients with cirrhosis and sleep disturbances: A randomized, placebo-controlled trial
Manoj Kumar SHARMA ; Sumeet KAINTH ; Sachin KUMAR ; Ankit BHARDWAJ ; Hemant Kumar AGARWAL ; Rakhi MAIWALL ; Kapil Dev JAMWAL ; Saggere Muralikrishna SHASTHRY ; Ankur JINDAL ; Ashok CHOUDHARY ; Lovkesh ANAND ; Rajender Mal DHAMIJA ; Guresh KUMAR ; Barjesh Chander SHARMA ; Shiv Kumar SARIN
Clinical and Molecular Hepatology 2019;25(2):199-209
BACKGROUND/AIMS: The aim of this study was to study the efficacy and safety of zolpidem for sleep disturbances in patients with cirrhosis. METHODS: Fifty-two Child-Turcotte-Pugh (CTP) class A or B cirrhotics with Pittsburgh Sleep Quality Index >5 were randomized to either zolpidem 5 mg daily (n=26) or placebo (n=26) for 4 weeks. RESULTS: The therapy of 4 weeks was completed by 23 patients receiving zolpidem (3 stopped treatment due to excessive daytime drowsiness) and 24 receiving placebo (2 refused to continue the study). In the zolpidem group, after 4 weeks of therapy, there was significant increase in total sleep time (TST) and sleep efficiency compared to baseline and improvement in polysomnographic parameters of sleep initiation and maintenance (i.e., decrease in sleep latency time, decrease in wake time, and decreases in number of arousals and periodic limbs movements per hour of sleep), without any significant change in sleep architecture. CONCLUSIONS: Four weeks of 5 mg daily zolpidem in CTP class A or B cirrhosis patients with insomnia led to significant increases in TST and sleep efficiency and improvement in polysomnographic parameters of sleep initiation and maintenance without any significant change in sleep architecture.
Arousal
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Cytidine Triphosphate
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Extremities
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Fibrosis
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Humans
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Sleep Initiation and Maintenance Disorders
Result Analysis
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