"The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambi"...
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 [see 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.
DOSAGE AND ADMINISTRATION
The dose of Zolpimist (zolpidem tartrate oral spray) should be individualized.
Dosage in adults
The recommended dose for adults is 10 mg once daily immediately before bedtime. The total Zolpimist (zolpidem tartrate oral spray) dose should not exceed 10 mg per day.
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 (zolpidem tartrate oral spray) in both of these patient populations is 5 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS ].
Use with CNS depressants
Dosage adjustment may be necessary when Zolpimist (zolpidem tartrate oral spray) is combined with other CNS-depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS].
Zolpimist (zolpidem tartrate oral spray) is packaged in a child-resistant container. For detailed instructions on how to use Zolpimist (zolpidem tartrate oral spray) , refer to the Patient Instructions for Use (following the Medication Guide). Zolpimist (zolpidem tartrate oral spray) 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 (zolpidem tartrate oral spray) 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 (zolpidem tartrate oral spray) 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 (zolpidem tartrate oral spray) may be slowed by ingestion with or immediately after a meal.
Dosage Forms And Strengths
Zolpimist (zolpidem tartrate oral spray) 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.
Storage And Handling
Zolpimist (zolpidem tartrate oral spray) is available in a child-resistant container. Each container includes a child-resistant cap and base with a metered-dose pump assembly and clear over cap. Each container contains 8.2 g of product formulation. One and two actuations of Zolpimist are equal to 5 and 10 mg of zolpidem tartrate, respectively. There are 60 metered actuations per container after 5 initial priming actuations. Zolpimist (zolpidem tartrate oral spray) is supplied as:
|XXXXX-001-01||Carton includes a child-resistant container with 8.2 g of product formulation; 60 metered actuations per container|
Store upright at 25 °C (77 °F) with excursions permitted to 15-30 °C (59-86 °F) (USP Controlled Room Temperature). Do not freeze. Avoid prolonged product exposure to temperatures above 30 °C (86 °F). The child-resistant container should be discarded when the labeled number of actuations (60 sprays) have been used.
KEEP OUT OF REACH OF CHILDREN.
Revised December 2008. Manufactured for: NovaDel Pharma Inc., Flemington, NJ 08822. By : Rechon Life Sciences AB, SE-216 10 Limhamn, Sweden. FDA rev date: 12/19/2008This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/23/2009
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