About Zolpimist (zolpidem tartrate) Oral Spray

Efficacy Profile2

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 has a pharmacokinetic profile characterized by rapid absorption.4

  • No consistent evidence of next-day memory impairment6
  • No objective evidence of rebound insomnia7

For more safety information click here.

Once-daily dosing2

  • 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

  1. Symphony Health – PHAST Monthly Rx Data
  2. Zolpimist [package insert]. Englewood, CO: Aytu BioScience Inc.; 2019.
  3. 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).

  1. 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.; 2019.
  2. See Dosing/Administration tab for information about elderly, debilitated, and hepatically impaired patients.
  3. 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.; 2019.)
  1. 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.; 2019.)

The most commonly observed adverse reactions in controlled studies were drowsiness, dizziness, diarrhea, and drugged feelings.

WARNING: COMPLEX SLEEP BEHAVIORS

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of ZOLPIMIST. Some of these events may result in serious injuries, including death. Discontinue ZOLPIMIST immediately if a patient experiences a complex sleep behavior.

INDICATIONS AND USAGE

ZOLPIMIST (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.

The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZOLPIMIST is contraindicated in patients:

  • Who have experienced complex sleep behaviors after taking ZOLPIMIST.
  • With known hypersensitivity to zolpidem tartrate.

WARNINGS AND PRECAUTIONS

  • Complex Sleep Behaviors: Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any subsequent use of zolpidem. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Post-marketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants. Discontinue ZOLPIMIST immediately if a patient experiences a complex sleep behavior.
  • CNS Depressant Effects and Next-Day Impairment: Zolpidem tartrate, like other sedative-hypnotic drugs, has CNS-depressant effects. Due to the rapid onset of action, ZOLPIMIST should only be administered immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following administration of ZOLPIMIST.
  • Need to Evaluate for Co-Morbid Diagnoses: Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
  • Severe Anaphylactic and Anaphylactoid Reactions: Rare cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem.
  • Abnormal Thinking and Behavioral Changes: A variety of abnormal thinking and behavioral changes have been reported to occur in association with the use of sedative-hypnotics.
  • Withdrawal Effects: Following the rapid dose decrease or abrupt discontinuation of sedative-hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs.
  • Special Populations:

Use in the elderly and/or debilitated patients: Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative-hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. Therefore, the recommended ZOLPIMIST dosage is 5 mg in such patients to decrease the possibility of side effects. These patients should be closely monitored.

Use in patients with concomitant illness: Clinical experience with zolpidem tartrate in patients with concomitant systemic illness is limited. Caution is advisable in using ZOLPIMIST in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

ADVERSE EVENT REPORTING
To report suspected adverse events or product complaints, please contact Aytu BioScience at 855-AYTU-BIO; FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Open ISI

WARNING: COMPLEX SLEEP BEHAVIORS

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of ZOLPIMIST. Some of these events may result in serious injuries, including death. Discontinue ZOLPIMIST immediately if a patient experiences a complex sleep behavior.

INDICATIONS AND USAGE

ZOLPIMIST (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies.

The clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ZOLPIMIST is contraindicated in patients:

  • Who have experienced complex sleep behaviors after taking ZOLPIMIST.
  • With known hypersensitivity to zolpidem tartrate.

WARNINGS AND PRECAUTIONS

  • Complex Sleep Behaviors: Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following the first or any subsequent use of zolpidem. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Post-marketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants. Discontinue ZOLPIMIST immediately if a patient experiences a complex sleep behavior.
  • CNS Depressant Effects and Next-Day Impairment: Zolpidem tartrate, like other sedative-hypnotic drugs, has CNS-depressant effects. Due to the rapid onset of action, ZOLPIMIST should only be administered immediately prior to going to bed. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as operating machinery or driving a motor vehicle after ingesting the drug, including potential impairment of the performance of such activities that may occur the day following administration of ZOLPIMIST.
  • Need to Evaluate for Co-Morbid Diagnoses: Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
  • Severe Anaphylactic and Anaphylactoid Reactions: Rare cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem.
  • Abnormal Thinking and Behavioral Changes: A variety of abnormal thinking and behavioral changes have been reported to occur in association with the use of sedative-hypnotics.
  • Withdrawal Effects: Following the rapid dose decrease or abrupt discontinuation of sedative-hypnotics, there have been reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs.
  • Special Populations:

Use in the elderly and/or debilitated patients: Impaired motor and/or cognitive performance after repeated exposure or unusual sensitivity to sedative-hypnotic drugs is a concern in the treatment of elderly and/or debilitated patients. Therefore, the recommended ZOLPIMIST dosage is 5 mg in such patients to decrease the possibility of side effects. These patients should be closely monitored.

Use in patients with concomitant illness: Clinical experience with zolpidem tartrate in patients with concomitant systemic illness is limited. Caution is advisable in using ZOLPIMIST in patients with diseases or conditions that could affect metabolism or hemodynamic responses.

ADVERSE EVENT REPORTING
To report suspected adverse events or product complaints, please contact Aytu BioScience at 855-AYTU-BIO; FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.