Abstract Details

Title Sex Differences in Middle-of-the-Night Efficacy of Zolpidem Tartrate Sublingual Tablets in a 4-Week Insomnia Outpatient Trial

Topic Sleep

Presentation(s) P05 - (-)

Poster/Presentation
Number 013

Objective

Background BACKGROUND: ZST is indicated for as-needed use after appropriate MOTN awakenings. Across sexes, ZST decreased LSO over 4 weeks (baseline 68.1 min; ZST 38.2 min) compared with placebo (baseline 69.4 min; placebo 56.4 min; (P < 0.0001)). However, in that study, women received 3.5mg, twice the FDA-approved dose. These analyses assessed potential differences in sex-related efficacy of 3.5mg ZST.

Design/Methods DESIGN/METHODS: Multicenter, randomized, double-blind, placebo-controlled, parallel-group, 201 females/94 males (median 43 years), with primary insomnia characterized by difficulty returning to sleep after MOTN awakenings (?3 MOTN awakenings/week during screening). New analyses evaluated effects of sex and treatment*sex interactions. After 2-week placebo screening, subjects were randomized to as-needed MOTN dosing with 3.5mg ZST or placebo for 4 weeks. An IVRS determined if study drug could be taken and collected efficacy measures.

Results RESULTS: ZST significantly decreased LSO compared with placebo in females (ZST: baseline 68.6 min; treatment 37.3 min; placebo: baseline 72.6 min; treatment 59.4 min; p < 0.0001) and males (ZST: baseline 68.9 min; treatment 38.6 min; placebo: baseline 68.2 min; treatment 55.1 min; p < 0.006). Wake after MOTN awakening and ratings of morning sleepiness/alertness favored ZST in both sexes on nights medication was taken. There were no significant treatment*sex differences on any efficacy parameter. Adverse events were generally mild and not different between sexes or ZST/placebo. There were no treatment-related serious adverse events (SAEs). Dosing/week did not increase across the study in any treatment/sex group.

Conclusions CONCLUSIONS: 3.5mg ZST used prn significantly reduced LSO compared to placebo in both female and male insomnia patients. Postdosing wake time was less, and morning sleepiness/alertness scores improved. ZST was well tolerated in both sexes.

Authors/Disclosures
PRESENTER	No disclosure on file
Thomas Roth, PhD (Henry Ford Hospital)	Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Takeda. Dr. Roth has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Avadel. Dr. Roth has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz.
	No disclosure on file
	No disclosure on file
Rebecca Gottschalk (Novartis Pharmaceuticals)	No disclosure on file

��ɫ��

��ɫ��