Dosing and Administration

Zolpimist Oral Spray is available as a metered oral spray where each spray delivers 5 mg of zolpidem tartrate1.

Dosing

PatientsStrengths
Adult Females5 mg (initially)
Adult Males5 mg or 10 mg
Elderly or debilitated patients35 mg

Zolpimist Oral Spray should be sprayed over the tongue and into the back of the throat, and it should be taken immediately before bedtime. ‡1

Administration1

Do Remind Your Patients To

  • Take right before they go to bed, because Zolpimist Oral Spray works quickly
  • Take only if they’re able to stay in bed for a full night’s sleep (7-8 hours)
  • Spray Zolpimist Oral Spray over the tongue and into the back of the throat

Remind Your Patients, Do NOT

  • Do not swallow or drink water after dosing for about one minute
  • Take Zolpimist Oral Spray with alcohol
  • Take Zolpimist Oral Spray with a meal or right after a meal
  • Drive or do any dangerous activities, such as operating heavy machinery, after taking Zolpimist Oral Spray until you feel fully awake

Zolpimist is non-AB rated and should not be substituted.2


References

  1. Zolpimist [package insert]. Englewood, CO: Aytu BioScience Inc.; 2019
  2. Orange Book: approved drug products with therapeutic equivalence evaluations.http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Accessed August 21, 2015.
  3. Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. Therefore, the recommended dose of Zolpimist in these patient populations is 5 mg once daily immediately before bedtime. These patients should be closely monitored. Since sedative/hypnotics have the capacity to depress respiratory drive, precautions should be taken with patients who have compromised respiratory function and chronic obstructive pulmonary disease. Zolpimist should be used with caution in patients with signs or symptoms of depression. The least amount of drug that is feasible should be prescribed for the patient at any one time.

 Patients should be counseled to take Zolpimist right before they get in bed and only when they are able to stay in bed a full night (7-8 hours) before being active again.

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.