ZOLPIMIST

ZOLPIMIST- zolpidem tartrate spray, metered
Aytu BioPharma, Inc.

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 [see Contraindications ( 4) and Warnings and Precautions ( 5.1)].

1 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 [see Clinical Studies ( 14)].

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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adults

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. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions ( 5.1)] . The total dose of ZOLPIMIST should not exceed 10 mg once daily immediately before bedtime.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

2.2 Special Populations

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. The recommended dose of ZOLPIMIST in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions ( 5.7); Use in Specific Populations( 8.5)].

2.3 Use with CNS Depressants

Dosage adjustment may be necessary when ZOLPIMIST is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions ( 5.2)].

2.4 Administration

ZOLPIMIST is packaged in a child-resistant container. For detailed instructions on how to use ZOLPIMIST, refer to the Patient Instructions for Use (following the Medication Guide). ZOLPIMIST must be primed before it is used for the first time. To prime, patients should be told to point the black spray opening away from their face and other people and spray 5 times. For administration, the child-resistant container should be held upright with the black spray opening pointed directly into the mouth. The patient should fully press down on the pump to make sure a full dose (5 mg) of ZOLPIMIST is sprayed directly into the mouth over the tongue. If a 10 mg dose is prescribed, a second spray should be administered.

If the patient does not use ZOLPIMIST for at least 14 days, it must be primed again with 1 spray. The patient should be referred to the Patient Instructions for Use included at the end of the Medication Guide.

The effect of ZOLPIMIST may be slowed by ingestion with or immediately after a meal.

3 DOSAGE FORMS AND STRENGTHS

ZOLPIMIST is available as a clear, colorless, and cherry flavored solution designed to be sprayed directly into the mouth over the tongue. Each metered actuation (one spray) of ZOLPIMIST delivers 5 mg of zolpidem tartrate in 100 μL. Two actuations deliver 10 mg of zolpidem tartrate. After an initial priming of 5 actuations, there are 60 metered actuations in each child-resistant container. The total number of available doses is dependent on the number of actuations per dose (1 or 2 actuations) and the frequency of priming.

4 CONTRAINDICATIONS

ZOLPIMIST is contraindicated in patients: ZOLPIMIST is contraindicated in patients:

  • who have experienced complex sleep behaviors after taking ZOLPIMIST [see Warnings and Precautions ( 5.1)] [see Warnings and Precautions ( 5.1)]
  • with known hypersensitivity to zolpidem tartrate [ see Warnings and Precautions ( 5.7)].

5 WARNINGS AND PRECAUTIONS

5.1 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. 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 [see Drug Interactions ( 7.1)]. Discontinue ZOLPIMIST immediately if a patient experiences a complex sleep behavior.

5.2 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. Zolpidem tartrate showed additive effects when combined with alcohol and should not be taken with alcohol. Patients should also be cautioned about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when ZOLPIMIST is administered with such agents because of the potentially additive effects. 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. Zolpidem tartrate showed additive effects when combined with alcohol and should not be taken with alcohol. Patients should also be cautioned about possible combined effects with other CNS-depressant drugs. Dosage adjustments may be necessary when ZOLPIMIST is administered with such agents because of the potentially additive effects.

Because ZOLPIMIST can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls. Because ZOLPIMIST can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.

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