Sublingual dosage (sublingual tablets; e.g., Edluar). Adult Females. Initially, 5 mg sublingually immediay before bedtime and with at least 7 to 8 hours.
Thank you. Your has been sent. Benzodiazepine Related Sedative/Hypnotics Rx, schedule IV.
Non-benzodiazepine hypnotic. Used for insomnia to aide in sleep initiation; some products may be used for middle-of-the night awakenings. Available in immediate and extended release formulations; rapid onset and short half-life reduces 'hangover' effects; does not cause early-AM awakening.
If the sleep agent is used routinely and is beyond the manufacturer's recommendations for duration of use, the facility should attempt a quarterly taper unless clinically contraindicated as defined in the OBRA guidelines.
The recommended dose for Edluar for adults is 10 mg once daily immediay before bedtime. The total Edluar daily dose.
premarketing clinical trials discontinued treatment because of an adverse reaction. Reactions most commonly associated with discontinuation from U.S. trials were daytime drowsiness (0.5%), dizziness (0.4%), headache (0.5%), nausea (0.6%), and vomiting (0.5%). Approximay 4% of 1,701 patients who received zolpidem tartrate at all doses (1.25 to 90 mg) in U.S.
The dose of Edluar should be individualized.
To provide a meaningful estimate of the proportion of individuals experiencing treatment-emergent adverse events, similar types of untoward events were grouped into a smaller number of standardized event categories and classified utilizing a modified World Health Organization (WHO) dictionary of preferred terms.
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l your doctor right away if you have any serious side effects, including: memory loss, mental/mood/behavior changes (such as new/worsening depression, abnormal thoughts, thoughts of suicide, hallucinations, confusion, agitation, aggressive behavior, anxiety ).
If either of these effects persists or worsens, l your doctor or pharmacist promptly.
Detailed dosage guidelines and administration information for Edluar (zolpidem tartrate). Includes dose adjustments, warnings and precautions.
The total dose of Edluar should not exceed 10 mg once daily immediay before bedtime. If the 5 mg dose is not effective, the dose can be increased to 10 mg. 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 immediay before bedtime with at least 7-8 hours remaining before the planned time of awakening. 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 )].
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Dosage adjustments of Edluar and of other concomitant CNS depressants may be necessary when administered together because of the potentially additive.
Edluar tablets are designed to be taken under the tongue and should not be swallowed or taken with water or other liquids.1.
Start with the lowest effective dose for the patient, to be taken immediay before bedtime1:
Zolpidem tartrate has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. Edluar (zolpidem tartrate) sublingual tablets, a gamma-aminobutyic acid (GABA) A agonist, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
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To report adverse events or product complaints, please call Meda's pharmacovigilance team at (855) or the FDA at or visit www.fda.gov/medwatch.
Edluar. Reference: 1. Somerset, NJ: Meda Pharmaceuticals Inc.; 2014.