Important Safety Information for Patients Taking Zolpimist

Zolpimist (zolpidem tartrate) Oral Spray C-IV HCP Important Safety Information

  • Zolpimist is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after the first or subsequent doses of sedative-hypnotics, including zolpidem tartrate. Some patients have had additional symptoms such as dyspnea, throat closing, nausea and vomiting that suggest anaphylaxis. Airway obstruction may occur and be fatal. Patients who develop angioedema should not be rechallenged with the drug.
  • Zolpimist has central nervous system (CNS) depressant effects. Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of Zolpimist and of other concomitant CNS depressants may be necessary when administered together because of the potentially additive effects. The use of Zolpimist with other sedative-hypnotics 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, if a higher than the recommended dose is taken, if co-administered with other CNS depressants, or if coadministered with other drugs that increase the blood level of Zolpimist. Patients should be cautioned against driving and other activities requiring complete mental alertness if taken in these circumstances.
  • 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.
  • Abnormal thinking and behavior changes have been reported in patients treated with sedative/hypnotics, including zolpidem (e.g., aggressiveness, extroversion that seems out of character, bizarre behavior, agitation, depersonalization, visual and auditory hallucinations). 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. The use of alcohol or other CNS depressants increases the risk of such behaviors. 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 in patients who are not fully awake after taking a sedative-hypnotic. The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.
  • In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been reported. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in this group of patients; therefore, the least amount of drug that is feasible should be prescribed for the patient at any one time.
  • Since sedative-hypnotics have the capacity to depress respiratory drive, precautions should be taken if Zolpimist is prescribed to patients with compromised respiratory function including sleep apnea and myasthenia gravis.
  • There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem. Monitor patients for tolerance, abuse, and dependence. 1
  • During short-term treatment (up to 10 nights), the most common adverse reactions in controlled clinical trials were drowsiness (2%), dizziness (1%), and diarrhea (1%). During longer-term treatment (28 to 35 nights), the most common adverse reactions were dizziness (5%) and drugged feelings (3%).
  • Imipramine used in combination with zolpidem produced an additive effect of decreased alertness. Similarly, chlorpromazine used in combination with zolpidem produced impaired alertness and psychomotor performance.
  • Use of Rifampin, a CYP3A4 inducer, in combination with zolpidem may decrease the efficacy of zolpidem.
  • Use of Ketoconazole, a potent CYP3A4 inhibitor, in combination with zolpidem increased the pharmacodynamics effects of zolpidem. Consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together.
  • There are no adequate and well-controlled studies of Zolpimist in pregnant women. Zolpimist should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.
  • Zolpidem is excreted in human milk. Caution should be exercised when ZOLPIMIST is administered to a nursing woman.
  • Zolpimist is not recommended for use in children. Safety and effectiveness in pediatric patients have not been established in pediatric patients below the age of 18.
  • Zolpimist contains zolpidem tartrate, a Schedule IV controlled substance.
  • Use the lowest effective dose for the patient.
  • The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. The maximum recommended dose of Zolpimist is 10 mg once daily immediately before bedtime.
  • The recommended dose of Zolpimist in geriatric patients and patients with hepatic impairment is 5 mg once daily immediately before bedtime.
  • Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpimist.
  • The effect of Zolpimist may be slowed if taken with or immediately after a meal.

INDICATIONS AND USAGE
Zolpimist (zolpidem tartrate) Oral Spray, a gamma-aminobutyic acid (GABA) A agonist, 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.

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

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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