About Zolpimist (zolpidem tartrate) Oral Spray
Zolpimist Efficacy: Zolpidem tartrate, the #1-prescribed sleep agent,1 has been found to shorten the time it takes to complete the transition from being fully awake to being asleep.2
- Reduction in sleep-onset latency3
- Improvement in sleep quality3
- Fewer awakenings during the night3
- Increase total sleep time2
Safety Profile2, 5
Zolpimist Oral Spray contains the active ingredient zolpidem tartrate and have a pharmacokinetic profile characterized by rapid absorption.4
- No consistent evidence of next-day memory impairment6
- No objective evidence of rebound insomnia7
- Shown to preserve sleep stages
For more safety information click here.
- Recommended initial dose is 5 mg for women and 5 or 10 mg for men, immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening
- Symphony Health – PHAST Monthly Rx Data
- Zolpimist [package insert]. Englewood, CO: Aytu BioScience Inc.; 2018.
- Normal adults experiencing transient insomnia (n=462) during the first night in a sleep laboratory were evaluated in a double-blind, parallel group, single-night trial comparing two doses of zolpidem (7.5 and 10 mg) and placebo. Both zolpidem doses were superior to placebo on objective (polysomnographic) measures of sleep latency, sleep duration, and number of awakenings.
Normal elderly adults (mean age 68) experiencing transient insomnia (n=35) during the first two nights in a sleep laboratory were evaluated in a double-blind, crossover, 2-night trial comparing four doses of zolpidem (5, 10, 15, and 20 mg) and placebo. All zolpidem doses were superior to placebo on the two primary PSG parameters (sleep latency and efficiency) and all four subjective outcome measures (sleep duration, sleep latency, number of awakenings, and sleep quality).
- Zolpimist (Zolpidem tartrate) Oral Spray is bioequivalent to Ambien® tablets (Sanofi-Aventis). The pharmacokinetic profile of Zolpimist (zolpidem tartrate) Oral Spray is characterized by rapid absorption from the oral mucosa and gastrointestinal tract, and a short elimination t1/2 in healthy subjects. (Zolpimist [package insert]. Englewood, CO: Aytu BioScience Inc.; 2018.)
- See Dosing/Administration tab for information about elderly, debilitated, and hepatically impaired patients.
- Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of zolpidem tartrate. However, in one study involving zolpidem doses of 10 and 20 mg, there was a significant decrease in next morning recall of information presented to subjects during peak drug effect (90 minutes post-dose), i.e., these subjects experienced anterograde amnesia. There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of zolpidem tartrate, predominantly at doses above 10 mg. (Zolpimist [package insert]. Englewood, CO: Aytu BioScience Inc.; 2018.)
- There was no objective (polysomnographic) evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of zolpidem tartrate. There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses of zolpidem tartrate above the recommended elderly dose of 5 mg. (Zolpimist [package insert]. Englewood, CO: Aytu BioScience Inc.; 2018.)
The most commonly observed adverse reactions in controlled studies were drowsiness, dizziness, diarrhea, and drugged feelings.