Ambien CR/Zolpidem/Zolpidem Tartrate Oral Tab ER: 6.25mg, 12.5mg Avoid co-use with other sedative-hypnotics, including other zolpidem products. During.
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Patients should be cautioned regarding the risk of residual next-morning effects, and instructed to wait for at least 4 hours after dosing and until they feel fully awake before driving or engaging in other activities requiring full mental alertness. Use only if the patient has at least 4 hours of bedtime remaining before the planned time of waking. 3.5 mg sublingually taken once per night if needed for a middle-of-the night awakening followed by difficulty returning to sleep.
These highlights do not include all the information needed to use zolpidem tartrate tablets safely and effectively. See full prescribing information for zolpidem.
There is evidence from dose comparison trials suggesting a dose relationship for many of the adverse reactions associated with zolpidem use, particularly for certain CNS and gastrointestinal adverse events. Dose relationship for adverse reactions:.
Data from a clinical study in which selective serotonin reuptake inhibitor (SSRI)-treated patients were given zolpidem revealed that four of the seven discontinuations during double-blind treatment with zolpidem (n=95) were associated with impaired concentration, continuing or aggravated depression, and manic reaction; one patient treated with placebo (n=97) was discontinued after an attempted suicide.
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.
A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of sedative/hypnotics.
Zolpidem tartrate tablets are available in 5 mg and 10 mg strength tablets for oral administration. Zolpidem tartrate tablets 5 mg are pink, round, film-coated.
Infrequent: constipation, dysphagia, flatulence, gastroenteritis. Gastrointestinal system: Frequent: hiccup. Rare: enteritis, eructation, esophagospasm, gastritis, hemorrhoids, intestinal obstruction, rectal hemorrhage, tooth caries.
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 [see Drug Abuse and Dependence (9) ]
Musculoskeletal system: Infrequent: arthritis.
Find patient medical information for Zolpidem Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings.
Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior ( addiction ). Take this medication exactly as prescribed to lessen the risk of addiction. This risk may be increased if you have abused alcohol or drugs in the past.
Do not share this medication with others. It is against the law.
Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake (" sleep -driving").
It affects chemicals in your brain that may become unbalanced and cause sleep problems (insomnia). Zolpidem is a sedative, also called a hypnotic.
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Follow these directions carefully. Zolpidem comes with patient instructions for safe and effective use. Ask your doctor or pharmacist if you have any questions.
l your doctor if you are currently taking any of these medications.