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    Zolpimist 5mg/0.1ml Oral Spray- 4.5ml

    Product ID: *C4**ZOLPMIST4p5

    Zolpimist 5mg/0.1ml Oral Spray- 4.5ml

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    Product Summary

    This product requires a valid prescription for shipment, please note that HealthWarehouse.com may not accept prescriptions faxed or emailed by patients.
    • PRESCRIPTION REQUIRED
    • This medication MUST BE SHIPPED with SIGNATURE CONFIRMATION.
    • The original prescription must be mailed to us.
    • The doctor may also fax or call in the prescription information directly to one of our pharmacists.

    IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

    ZOLPIMIST ORAL SPRAY (5MG/0.1ML)

    WARNING: Rarely, after taking this drug, people have gotten out of bed and driven vehicles while not fully awake (\"sleep-driving\"). People have also sleepwalked, prepared/eaten food, made phone calls, or had sex while not fully awake. Often, these people do not remember these events. This problem can be dangerous (possibly fatal) to you or to others. If you find out that you have done any of these activities after taking this medication, tell your doctor right away. You should not take this medication or similar medications (such as eszopiclone, zaleplon) if you have this reaction to the medication.

    USES: This medication is used to treat a certain type of sleep problem (insomnia) in adults who have trouble falling back asleep after waking up in the middle of the night. It helps you return to sleep faster so you can get a better night\'s rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication should only be taken if you have at least 4 hours of bedtime left. Zolpidem is usually limited to short treatment periods of 1 to 2 weeks or less.

    HOW TO USE: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.

    SIDE EFFECTS: See also Warning section.The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Serious anaphylactic and anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]. Abnormal thinking, behavior changes, and complex behaviors [see WARNINGS AND PRECAUTIONS]. Withdrawal effects [see WARNINGS AND PRECAUTIONS]. CNS-depressant effects [see WARNINGS AND PRECAUTIONS].

    PRECAUTIONS: See also Warning section.Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavioral abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs, including zolpidem. Severe anaphylactic and anaphylactoid reactions Rare cases of angioedema involving the tongue, glottis, or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including zolpidem. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required 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 with zolpidem should not be rechallenged with the drug. Abnormal thinking and behavioral changes A variety of abnormal thinking and behavioral changes have been reported to occur in association with the use of sedative-hypnotics. Some of these changes may be characterized by decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), similar to effects produced by alcohol and other CNS depressants. Visual and auditory hallucinations have been reported as well as behavioral changes such as bizarre behavior, agitation, and depersonalization. In controlled trials, < 1% of adults with insomnia who received zolpidem reported hallucinations. In a clinical trial, 7.4% of pediatric patients with insomnia associated with attention-deficit/hyperactivity disorder (ADHD), who received zolpidem, reported hallucinations [see Use in Specific Populations]. Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported with sedative-hypnotics, including zolpidem. These events can occur in sedative-hypnotic-naive as well as in sedative­hypnotic-experienced persons. Although behaviors such as “sleep-driving” may occur with Zolpimist (zolpidem tartrate oral spray) alone at therapeutic doses, the use of alcohol and other CNS depressants with zolpidem tartrate appears to increase the risk of such behaviors, as does the use of zolpidem at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of Zolpimist (zolpidem tartrate oral spray) should be strongly considered for patients who report a “sleep-driving” episode. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with “sleep-driving”, patients usually do not remember these events. Amnesia, anxiety, and other neuropsychiatric symptoms may occur unpredictably. In primarily depressed patients, worsening of depression, including suicidal thoughts and actions (including completed suicides), has been reported in association with the use of sedative-hypnotics. It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

    DRUG INTERACTIONS: Since the systematic evaluations of zolpidem in combination with other CNS-active drugs have been limited, careful consideration should be given to the pharmacology of any CNS-active drug to be used with Zolpimist (zolpidem tartrate oral spray) . Any drug with CNS-depressant effects could potentially enhance the CNS-depressant effects of zolpidem. Zolpidem tartrate was evaluated in healthy subjects in single-dose interaction studies for several CNS drugs. Imipramine in combination with zolpidem produced no pharmacokinetic interaction other than a 20% decrease in peak levels of imipramine, but there was an additive effect of decreased alertness. Similarly, chlorpromazine in combination with zolpidem tartrate produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. A study involving haloperidol and zolpidem revealed no effect of haloperidol on the pharmacokinetics or pharmacodynamics of zolpidem. The lack of a drug interaction following single-dose administration does not predict a lack following chronic administration. An additive effect on psychomotor performance between alcohol and zolpidem was demonstrated [see WARNINGS AND PRECAUTIONS]. A single-dose interaction study with zolpidem 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions. When multiple doses of zolpidem and fluoxetine at steady-state concentrations were evaluated in healthy females, the only significant change was a 17% increase in the zolpidem half-life (t½). There was no evidence of an additive effect in psychomotor performance. Following five consecutive nightly doses of zolpidem 10 mg in the presence of sertraline 50 mg (17 consecutive daily doses at 7:00 am in healthy female volunteers), zolpidem maximum concentration (Cmax) was significantly higher (43%) and time to maximum concentration (Tmax) was significantly decreased (53%). Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by zolpidem. Drugs that affect drug metabolism via cytochrome P450 Some compounds known to inhibit CYP3A may increase exposure to zolpidem. The effect of inhibitors of other P450 enzymes has not been carefully evaluated. A randomized, double-blind, crossover interaction study in ten healthy volunteers between itraconazole (200 mg once daily for 4 days) and a single dose of zolpidem (10 mg) given 5 hours after the last dose of itraconazole resulted in a 34% increase in AUC0–∞ of zolpidem. There were no significant pharmacodynamic effects of zolpidem on subjective drowsiness, postural sway, or psychomotor performance. A randomized, placebo-controlled, crossover interaction study in eight healthy female subjects between five consecutive daily doses of rifampin (600 mg) and a single dose of zolpidem (20 mg) given 17 hours after the last dose of rifampin showed significant reductions of the AUC (– 73%), Cmax (–58%), and t½ (–36%) of zolpidem, together with significant reductions in the pharmacodynamic effects of zolpidem. A randomized double-blind crossover interaction study in twelve healthy subjects showed that co-administration of single 5 mg dose of zolpidem tartrate with ketoconazole, a potent CYP3A4 inhibitor, given as 200 mg twice daily for 2 days increased Cmax of zolpidem by a factor of 1.3 and increased the total AUC of zolpidem by a factor of 1.7 compared to zolpidem alone and prolonged the t1/2 by approximately 30% along with an increase in the pharmacodynamic effects of zolpidem. Caution should be used when ketoconazole is given with zolpidem and consideration should be given to using a lower dose of zolpidem when ketoconazole and zolpidem are given together. Patients should be advised that use of Zolpimist (zolpidem tartrate oral spray) with ketoconazole may enhance the sedative effects.

    NOTES: Do not share this medication with others. Sharing it is against the law. As you get older, your sleep pattern may naturally change and your sleep may be interrupted several times during the night. Consult your doctor or pharmacist for ways to improve your sleep without medication, such as avoiding caffeine and alcohol close to bedtime, avoiding daytime naps, and going to bed at the same time each night.

    MISSED DOSE: Not applicable.

    STORAGE: 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.

    Information last revised August 2019. Copyright(c) 2019 First Databank, Inc.

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