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Created with Fabric.js 1.4.5 AmbienZolpidem Route of Administration: Trade Name: by mouth (tablet), sublingual (under tongue tablet), or lingual (spray) Common Dosage: women - 5 mg men - either 5 or 10 mg taken only once per night immediately before bedtime with at least 78 hours remaining before the planned time of awakening. 5mg 6 tabs =71.40 or $11.90 per unit Pharmacokinetics -absorption: tablets take about1.5 hours, sublingual: 35-80 minutes, oral spray: 0.9 hours-distribution: distributed into milk in small amounts-metabolism: metabolized in the liver-excretion: eliminated principally through urine in the urinary tract 10 mg 20 tablets =$88.04 or $10.60 per unit Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. Patients with hepatic insufficiency do not clearthe drug as rapidly as normal subjects. The recommended dose of AMBIEN in both of these patient populations is 5 mg once daily immediately before bedtime. Special populations: AMBIEN (zolpidem tartrate) isindicated for the short-termtreatment of insomniacharacterized by difficulties withsleep initiation.AMBIEN has been shown todecrease sleep latency forup to 35 days in controlledclinical studies. Indications/Usage: Greg Zamarripa Contraindictions: Ambien is contraindicated in patients with known hypersensitivity to zolpidem. Observed reactions includeanaphylaxis and angioedema.Cases of angioedema (swelling) involvingthe tongue, glottis or larynx have been reported in patients after taking the first orsubsequent doses of sedative-hypnotics, including zolpidem.Some patients have had additional symptoms such as dyspnea,throat closing or nausea and vomiting that suggestanaphylaxis (allergic reaction). Some patients haverequired medical therapy in the emergency department.If angioedema involves the throat, glottis or larynx,airway obstruction may occur and be fatal.Patients who develop angioedema after treatment withzolpidem should not be rechallenged with the drug. Ambien- Tablets 5 mg- Tablets 10 mgAmbien CR- Tablets, ER 6.25 mg- Tablets, ER 12.5 mgEdluar- Tablets, sublingual 5 mg- Tablets, sublingual 10 mgZolpimist- Spray, solution, lingual 5 mg/actuation Warnings/Precautions like other sedative-hypnotic drugs, it has central nervous system (CNS) depressant effects.Abnormal thinking and behavior changes have been reportedin patients treated with sedative/hypnotics, including Ambien.Some of these changes included decreased inhibition (e.g., aggressivenessand extroversion that seemed out of character), bizarre behavior,agitation and depersonalization. Visual and auditory hallucinationshave been reported. Zolpidem can cause drowsiness and a decreasedlevel of consciousness, which may lead to falls and consequently to severe injuries. Mechanism of Action: Its a hypnotic agent with a chemical structure unrelated tobenzodiazepines, barbiturates, or other drugs with known hypnotic properties.It interacts with a GABA-BZ receptor complex and shares some of the pharmacological properties of the benzodiazepines.In contrast to the benzodiazepines, which non-selectively bind to and activate all BZ receptor subtypes, zolpidem in vitro bindsthe BZ1 receptor preferentially with a high affinity ratio of the α15 subunits. This selective binding of zolpidem on theBZ1 receptor is not absolute, but it may explain the relative absence of myorelaxant and anticonvulsant effects in animal studies as well as the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem tartrate at hypnotic doses. Clinical Studies: Insomnia: Normal adults, as well as the elderly, experiencing insomniaduring the first 2 nights in a sleep lab were evaluated in a double blind,1 night trial comparing 2 doses for adults and 2 night trial comparing 4doses for elderly (of zolpidem) along with a placebo. Chronic insomnia extends to weeks of monitored testing for subjects.The tests last between 4 5 weeks. Zolpidem was evaluated in twocontrolled studies for the treatment of patients with chronic insomnia(most closely resembling primary insomnia, as defined in the APADiagnostic and Statistical Manual of Mental Disorders, DSM-IV). Studies Pertinent to Safety Concerns for Sedative/Hypnotic Drugs: Next-day residual effects: Next-day residual effects of Ambien were evaluated inseven studies involving normal subjects. In three studies in adults (including onestudy in a phase advance model of transient insomnia) and in one study in elderly subjects,a small but statistically significant decrease in performance was observed in theDigit Symbol Substitution Test (DSST) when compared to placebo. Studies of Ambien in non-elderly patients with insomnia did not detect evidence of next-dayresidual effects using the DSST, the Multiple Sleep Latency Test (MSLT), and patient ratings of alertness. Rebound effects: There was no objective (polysomnographic) evidence of rebound insomniaat recommended doses seen in studies evaluating sleep on the nights followingdiscontinuation of Ambien (zolpidem tartrate). There was subjective evidenceof impaired sleep in the elderly on the first post-treatment night atdoses above the recommended elderly dose of 5 mg. Memory impairment:Controlled studies in adults utilizing objective measures ofmemory yielded no consistent evidence of next-day memory impairmentfollowing the administration of Ambien. However, in one study involvingzolpidem doses of 10 and 20 mg, there was a significantdecrease in next-morning recall of information presented tosubjects during peak drug effect (90 minutes post-dose),i.e., these subjects experienced anterograde amnesia.There was also subjective evidence from adverse event datafor anterograde amnesia occurring in association with theadministration of Ambien, predominantly at doses above 10 mg. Effects on sleep stages:In studies that measured the percentage of sleep timespent in each sleep stage, Ambien has generally beenshown to preserve sleep stages. Sleep time spent instages 3 and 4 (deep sleep) was found comparableto placebo with only inconsistent, minor changesin REM (paradoxical) sleep at the recommended dose.
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