OBJECTIVE: To compare the efficacy of sublingual Zolpidem (5 and 10mg) to conventional oral Zolpidem (10mg). METHODS: This was an open, randomized, double-blind, double-dummy, controlled, and single center study. The study took place at the Laboratory of Clinical Neurophysiology and total number of participants was 58 volunteers completed the study whose demographics of age, gender, body mass index (BMI) were similar among everyone. Scores in Epworth, Pittsburgh, Beck and Hamilton Scales did not differ among groups. A model of transient insomnia was determined by the sleep anticipation in 120minute. Subjects were randomly divided in three groups for drug administration (5mSL; 10mgSL and 10mg oral), given in a single dose prior to polysomnography (PSG). Sleep parameters were assessed by PSG and post-sleep questionnaires. RESULTS: A significant main treatment effect was evident considering the sleep onset latency (SOL) and persistent sleep latency (PSL). An earlier sleep onset was induced by SL Zolpidem 10mg (SOL=p<0.004; PSL=p<0.006) and SL Zolpidem 5mg (SOL=p<0.025; PSL=p<0.046) compared to oral Zolpidem 10mg. Subjects that received SL Zolpidem 10mg reported an earlier sleep onset (latency to sleep and latency until persistent sleep) when compared to subjects from other groups (p<0.005). CONCLUSIONS:Sublingual Zolpidem, both 5 and 10mg, induced faster sleep initiation than 10mg oral Zolpidem. A subjective perception of earlier sleep onset was reported by subjects using SL 10mg.
RCT Entities:
OBJECTIVE: To compare the efficacy of sublingual Zolpidem (5 and 10mg) to conventional oral Zolpidem (10mg). METHODS: This was an open, randomized, double-blind, double-dummy, controlled, and single center study. The study took place at the Laboratory of Clinical Neurophysiology and total number of participants was 58 volunteers completed the study whose demographics of age, gender, body mass index (BMI) were similar among everyone. Scores in Epworth, Pittsburgh, Beck and Hamilton Scales did not differ among groups. A model of transient insomnia was determined by the sleep anticipation in 120minute. Subjects were randomly divided in three groups for drug administration (5mSL; 10mgSL and 10mg oral), given in a single dose prior to polysomnography (PSG). Sleep parameters were assessed by PSG and post-sleep questionnaires. RESULTS: A significant main treatment effect was evident considering the sleep onset latency (SOL) and persistent sleep latency (PSL). An earlier sleep onset was induced by SL Zolpidem 10mg (SOL=p<0.004; PSL=p<0.006) and SL Zolpidem 5mg (SOL=p<0.025; PSL=p<0.046) compared to oral Zolpidem 10mg. Subjects that received SL Zolpidem 10mg reported an earlier sleep onset (latency to sleep and latency until persistent sleep) when compared to subjects from other groups (p<0.005). CONCLUSIONS: Sublingual Zolpidem, both 5 and 10mg, induced faster sleep initiation than 10mg oral Zolpidem. A subjective perception of earlier sleep onset was reported by subjects using SL 10mg.