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 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.

Once-daily dosing1

  • 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.; 2018.
  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.; 2018.)
  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.; 2018.)
  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.; 2018.)

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

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Zolpimist (zolpidem tartrate) Oral Spray 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

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Zolpimist (zolpidem tartrate) Oral Spray 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

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Zolpimist (zolpidem tartrate) Oral Spray 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.

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Important Safety Information

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Contraindications

Zolpimist Oral Spray is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions with zolpidem include anaphylaxis and angioedema.

Warnings and Precautions

  • Central Nervous System (CNS) Depressant Effects and Next-day Impairment: Zolpimist has CNS depressant Co-administration with other CNS depressants increases the risk of CNS depression. Dosage adjustments of Zolpimist and of other concomitant CNS depressants may be necessary. Use of Zolpimist with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.  The risk of next-day psychomotor impairment, including impaired driving, is increased if Zolpimist is taken with less than a full night  of sleep remaining (7 to 8 hours), if a higher than the recommended dose is taken, if co-administered with other CNS depressants, or if co-administered with other drugs that increase the blood levels of zolpidem.  Caution patients against driving and other activities requiring complete mental alertness if Zolpimist is taken in these circumstances.
  • Need to Evaluate for Co-Morbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of
  • Severe Anaphylactic and Anaphylactoid Reactions: Angioedema and anaphylaxis have been Some patients have required medical therapy in the emergency department. If angioedema involves the throat, glottis, or larynx, airway obstruction may occur and be fatal. Do not rechallenge if such reactions occur.
  • Abnormal Thinking and Behavioral Changes: Some of these changes included decreased inhibit ion, bizarre behavior, agitation, and Visual and auditory hallucinations have been reported. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported in sedative­ hypnotic-naive as well as in sedative-hypnotic- experienced persons. Risk increases with dose and   use with other CNS depressants and alcohol. Discontinuation of Zolpimist should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported; patients usually do not remember these events. Amnesia, anxiety, and other neuropsychiatric symptoms may also occur.
  • Depression: In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been Suicidal tendencies may be present and intentional overdosage is more common in this group of patients. Prescribe the least amount of sprays feasible to avoid intentional overdose.
  • Respiratory Depression: Consider this risk before prescribing in patients with compromised respiratory function.
  • Withdrawal Effects: Symptoms may occur with rapid dose reduction or

Adverse Reactions

The most commonly observed adverse reactions were:

  • Short-term (< 10 nights): Drowsiness, dizziness, and diarrhea
  • Long-term (28-35 nights): Dizziness and drugged feelings