SLEEP. DELIVERED.FAST

Zolpimist oral spray for the short-term treatment of insomnia

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

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

To report suspected adverse events or product complaints, please email Aytu BioScience at zolpimist@aytubio.com; FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.