Zolpidem tartrate typical dosage of zoloft

By | 29.04.2018

zolpidem tartrate typical dosage of zoloft

In studies performed with other zolpidem formulations 5 mg to 10 mg oral zolpidem tartrate given at bedtime, there was no objective polysomnographic evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation. Read the Medication Guide that comes with Ambien before you start taking it and each time you get a refill. Moderate It is advisable to closely monitor zolpidem tolerability and safety during concurrent use of isavuconazonium, a moderate CYP3A4 inhibitor, since CYP3A4 is the primary isoenzyme responsible for zolpidem metabolism. Subscribe to receive email notifications whenever new articles are published. Ambien Zolpidem is prescribed for short-term use. Moderate Concomitant use of nabilone with other CNS depressants can potentiate the effects of nabilone on respiratory depression. Medical Miracles With Ambien (Zolpidem Tartrate)

Studies of abuse potential in former drug abusers found that the effects of single doses of Zolpidem tartrate 40 mg were similar, but not identical, to diazepam 20 mg, while Zolpidem tartrate 10 mg was difficult to distinguish from placebo. Because persons with a history of addiction to, or abuse of, drugs or alcohol are at increased risk for misuse, abuse and addiction of Zolpidem, they should be monitored carefully when receiving Zolpidem or any other hypnotic.

These reported symptoms range from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. However, available data cannot provide a reliable estimate of the incidence, if any, of dependence during treatment at recommended doses. Post-marketing reports of abuse, dependence and withdrawal have been received. General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate.

Intravenous fluids should be administered as needed. Zolpidem's sedative hypnotic effect was shown to be reduced by flumazenil and therefore may be useful; however, flumazenil administration may contribute to the appearance of neurological symptoms convulsions. As in all cases of drug overdose, respiration, pulse, blood pressure, and other appropriate signs should be monitored and general supportive measures employed. Hypotension and CNS depression should be monitored and treated by appropriate medical intervention.

Sedating drugs should be withheld following Zolpidem overdosage, even if excitation occurs. The value of dialysis in the treatment of overdosage has not been determined, although hemodialysis studies in patients with renal failure receiving therapeutic doses have demonstrated that Zolpidem is not dialyzable. As with the management of all overdosage, the possibility of multiple drug ingestion should be considered.

The physician may wish to consider contacting a poison control center for up-to-date information on the management of hypnotic drug product overdosage. Zolpidem tartrate is a gamma-aminobutyric acid GABA A agonist of the imidazopyridine class and is available in 5 mg and 10 mg strength tablets for oral administration. It has the following structure:. Zolpidem tartrate is a white to almost white crystalline powder that is slightly soluble in water, sparingly soluble in methanol.

It has a molecular weight of Each Zolpidem tartrate tablet includes the following inactive ingredients: Zolpidem, the active moiety of Zolpidem tartrate, is a hypnotic agent with a chemical structure unrelated to benzodiazepines, 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. This selective binding of Zolpidem on the BZ 1 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.

In a single-dose crossover study in 45 healthy subjects administered 5 and 10 mg Zolpidem tartrate tablets, the mean peak concentrations C max were 59 range: The mean Zolpidem tartrate tablets elimination half-life was 2. Zolpidem tartrate tablet is converted to inactive metabolites that are eliminated primarily by renal excretion.

Zolpidem tartrate tablets demonstrated linear kinetics in the dose range of 5 to 20 mg. Total protein binding was found to be Zolpidem did not accumulate in young adults following nightly dosing with 20 mg Zolpidem tartrate tablets for 2 weeks. A food-effect study in 30 healthy male subjects compared the pharmacokinetics of Zolpidem tartrate tablets 10 mg when administered while fasting or 20 minutes after a meal. The half-life remained unchanged. These results suggest that, for faster sleep onset, Zolpidem tartrate tablets should not be administered with or immediately after a meal.

In the elderly, the dose for Zolpidem tartrate tablets should be 5 mg [see Warnings and Precautions 5 and Dosage and Administration 2 ]. Zolpidem tartrate tablets did not accumulate in elderly subjects following nightly oral dosing of 10 mg for 1 week. The pharmacokinetics of Zolpidem tartrate tablet in eight patients with chronic hepatic insufficiency were compared to results in healthy subjects.

Following a single 20 mg oral Zolpidem tartrate dose, mean C max and AUC were found to be two times vs. T max did not change. The mean half-life in cirrhotic patients of 9. Dosing should be modified accordingly in patients with hepatic insufficiency [ see Dosage and Administration 2. No statistically significant differences were observed for C max , T max , half-life, and AUC between the first and last day of drug administration when baseline concentration adjustments were made.

Zolpidem was not hemodialyzable. No accumulation of unchanged drug appeared after 14 or 21 days. Zolpidem pharmacokinetics were not significantly different in renally impaired patients. No dosage adjustment is necessary in patients with compromised renal function. Similarly, chlorpromazine in combination with Zolpidem produced no pharmacokinetic interaction, but there was an additive effect of decreased alertness and psychomotor performance. The lack of a drug interaction following single-dose administration does not predict the absence of an effect following chronic administration.

Following five consecutive nightly doses at bedtime of oral Zolpidem tartrate 10 mg in the presence of sertraline 50 mg 17 consecutive daily doses, at 7: Pharmacokinetics of sertraline and N-desmethylsertraline were unaffected by Zolpidem. A single-dose interaction study with Zolpidem tartrate 10 mg and fluoxetine 20 mg at steady-state levels in male volunteers did not demonstrate any clinically significant pharmacokinetic or pharmacodynamic interactions.

There was no evidence of an additive effect in psychomotor performance. The effect of inhibitors of other P enzymes on the pharmacokinetics of Zolpidem is unknown. There were no pharmacodynamic effects of Zolpidem detected on subjective drowsiness, postural sway, or psychomotor performance. Zolpidem tartrate had no effect on digoxin pharmacokinetics and did not affect prothrombin time when given with warfarin in healthy subjects. In mice, these doses are approximately 2.

No evidence of carcinogenic potential was observed in mice. In rats, renal tumors lipoma, liposarcoma were seen at the mid- and high doses. Zolpidem was negative in in vitro bacterial reverse mutation, mouse lymphoma, and chromosomal aberration and in vivo mouse micronucleus genetic toxicology assays. There was no impairment of fertility at any dose tested.

Both Zolpidem doses were superior to placebo on objective polysomnographic measures of sleep latency, sleep duration, and number of awakenings. All Zolpidem doses were superior to placebo on the two primary PSG parameters sleep latency and efficiency and all four subjective outcome measures sleep duration, sleep latency, number of awakenings, and sleep quality. On objective polysomnographic measures of sleep latency and sleep efficiency, Zolpidem 10 mg was superior to placebo on sleep latency for the first 4 weeks and on sleep efficiency for weeks 2 and 4.

Zolpidem was comparable to placebo on number of awakenings at both doses studied. Zolpidem 10 mg was superior to placebo on a subjective measure of sleep latency for all 4 weeks, and on subjective measures of total sleep time, number of awakenings, and sleep quality for the first treatment week. Increased wakefulness during the last third of the night as measured by polysomnography has not been observed in clinical trials with Zolpidem tartrate tablets.

Next-day residual effects of Zolpidem tartrate tablets were evaluated in seven studies involving normal subjects. In three studies in adults including one study 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 the Digit Symbol Substitution Test DSST when compared to placebo. There was no objective polysomnographic evidence of rebound insomnia at recommended doses seen in studies evaluating sleep on the nights following discontinuation of Zolpidem tartrate.

There was subjective evidence of impaired sleep in the elderly on the first post-treatment night at doses above the recommended elderly dose of 5 mg. Controlled studies in adults utilizing objective measures of memory yielded no consistent evidence of next-day memory impairment following the administration of Zolpidem tartrate tablets. However, in one study involving Zolpidem doses of 10 and 20 mg, there was a significant decrease in next-morning recall of information presented to subjects during peak drug effect 90 minutes post-dose , i.

There was also subjective evidence from adverse event data for anterograde amnesia occurring in association with the administration of Zolpidem tartrate tablets, predominantly at doses above 10 mg. Effects on sleep stages: In studies that measured the percentage of sleep time spent in each sleep stage, Zolpidem tartrate tablets has generally been shown to preserve sleep stages.

Sleep time spent in stages 3 and 4 deep sleep was found comparable to placebo with only inconsistent, minor changes in REM paradoxical sleep at the recommended dose. Zolpidem tartrate tablets 5 mg are pink, film coated, capsule shaped tablets, debossed with "W" on one side and plain on the other side:. Zolpidem tartrate tablets 10 mg are white, film coated, capsule shaped tablets, debossed with "W" on one side and plain on the other side:. Inform patients and their families about the benefits and risks of treatment with Zolpidem tartrate tablets.

Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with Zolpidem tartrate tablets and with each prescription refill. Review the Zolpidem tartrate tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that Zolpidem tartrate tablets should be taken only as prescribed.

Tell patients that Zolpidem tartrate tablets have the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Severe Anaphylactic and Anaphylactoid Reactions.

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with Zolpidem. Sleep-driving and Other Complex Behaviors. Instruct patients and their families that sedative hypnotics can cause abnormal thinking and behavior change, including "sleep driving" and other complex behaviors while not being fully awake preparing and eating food, making phone calls, or having sex.

Tell patients to call you immediately if they develop any of these symptoms. Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use Zolpidem tartrate tablets if they drank alcohol that evening or before bed. Tell patients not to increase the dose of Zolpidem tartrate tablets on their own, and to inform you if they believe the drug "does not work".

Patients should be counseled to take Zolpidem tartrate tablets right before they get into bed and only when they are able to stay in bed a full night 7 to 8 hours before being active again. Zolpidem tartrate tablets should not be taken with or immediately after a meal. Advise patients NOT to take Zolpidem tartrate tablets if they drank alcohol that evening. Read the Medication Guide that comes with Zolpidem tartrate tablets before you start taking it and each time you get a refill.

There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Call your healthcare provider right away if you find out that you have done any of the above activities after taking Zolpidem tartrate tablets. Zolpidem tartrate tablets are a sedative-hypnotic sleep medicine.

Zolpidem tartrate tablets are used in adults for the short-term treatment of a sleep problem called insomnia trouble falling asleep. It is not known if Zolpidem tartrate tablets are safe and effective in children under the age of 18 years. Symptoms of a serious allergic reaction to Zolpidem can include:. O swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. Zolpidem tartrate tablets may not be right for you.

Before starting Zolpidem tartrate tablets, tell your healthcare provider about all of your health conditions, including if you:. Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects. Do not take Zolpidem tartrate tablets with other medicines that can make you sleepy unless your healthcare provider tells you to.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine. Call your healthcare provider right away if you have any of the above side effects or any other side effects that worry you while using Zolpidem tartrate tablets.

After you stop taking a sleep medicine, you may have symptoms for 1 to 2 days such as:. These are not all the side effects of Zolpidem tartrate tablets. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Zolpidem tartrate tablets for a condition for which it was not prescribed.

Do not share Zolpidem tartrate tablets with other people, even if they have the same symptoms that you have. It may harm them and it is against the law. This Medication Guide summarizes the most important information about Zolpidem tartrate tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Zolpidem tartrate tablets that is written for healthcare professionals.

Insomnia melatonin , lorazepam , amitriptyline , Ambien , Ativan , diphenhydramine , temazepam , doxepin , Elavil , Restoril , Lunesta , Ibuprofen PM , eszopiclone , Belsomra , Rozerem , triazolam , zaleplon , ramelteon , Sonata , doxylamine , Halcion , Silenor , flurazepam , estazolam , More The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. The risk for next-morning impairment is higher if zolpidem is taken with less than a full night of sleep remaining 7 to 8 hours , if a higher than the recommended dose is taken, or if zolpidem is co-administered with other CNS depressants or drugs that increase the blood levels of zolpidem.

A full night of sleep 7 to 8 hours is recommended to minimize the risk of next-day impairment. Initially, 5 to 10 mg PO immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; 5 mg PO immediately before bedtime is the final dose recommended for debilitated adults. Geriatric patients and debilitated adults are particularly sensitive to the effects of zolpidem. All sleep medications should be used in accordance with approved product labeling.

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. Initially, 5 mg sublingually immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; this is also the recommended dose for debilitated adults. Initially, 5 to 10 mg sublingually immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; 5 mg PO at bedtime provides sufficient efficacy for many men, and this lower dosage should be considered.

The 5 mg dose is recommended for debilitated adults. A full night of sleep 7 to 8 hours is recommended to minimize the risk of next-day impairment, including effects on driving and performing other tasks requiring complete mental alertness. Geriatric patients and debilitated adults may be particularly sensitive to the effects of the drug.

Administer as a single dose and do not be re-administer during the same night. In residents meeting the criteria for treatment, Max: Initially, 5 mg PO 1 spray in mouth over the tonque immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; this is also the recommended dose for debilitated adults. Initially, 5 to 10 mg PO 1 to 2 sprays in mouth over the tongue immediately before bedtime and with at least 7 to 8 hours remaining before the planned time of awakening; 5 mg 1 spray at bedtime provides sufficient efficacy for many men, and this lower dosage should be considered.

The recommended dose for debilitated adults is 6. Zolpidem should be taken as a single dose and should not be re-administered during the same night. A dose of 6. Patients should be cautioned regarding the risk of residual next-morning effects, and warned against engaging in hazardous activities, such as driving or other activities requiring complete mental alertness, the day after use until the patient is aware of how zolpidem affect them.

Avoid co-use with other sedative-hypnotics, including other zolpidem products at bedtime or in the middle of the night. Use only if the patient has at least 4 hours of bedtime remaining before the planned time of waking. The risk for next-morning impairment is higher if Intermezzo is taken with less than 4 hours of bedtime remaining, if a higher than the recommended dose is taken, or during co-administration with other CNS depressants or drugs that increase the blood levels of zolpidem.

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. A lower dose of 1. Avoid co-use with other sedative-hypnotics, including other zolpidem products, at bedtime or in the middle of the night. Use only when there are at least 4 hours of bedtime remaining before the planned time of waking.

Daily dose thresholds are not available for zolpidem use in middle-of-the night awakenings; use in accordance with approved product labeling. Zolpidem cannot be considered generally beneficial due to lack of well-controlled studies with statistical power, and apparent unpredictability of response. Clinical improvements typically occur within 1 hour of administration, with a duration of 1 to 4 hours. No long-term adverse effects were noted in 3 patients receiving the drug for 3 to 6 years.

In one small double-blind trial of 15 patients with MCS or VS of various etiologies receiving a single dose of zolpidem 10 mg and placebo in a cross-over design, one post-traumatic VS patient was considered a responder as determined by the Coma Recovery Scale-Revised CRS-R. Within 30 minutes of drug administration, the responder began to show more spontaneous movement, exploratory eye movements, visual tracking, and command following.

Re-challenge showed a less dramatic but superior response to placebo. An open-label study evaluated cerebral state monitoring CSM and single-photon emission computed tomography SPECT before and after a zolpidem 10 mg PO single dose in patients with VS who were categorized by the type of brain injury. Only patients with contrecoup contusion or space-occupying compression injuries had significant improvement in components of CSM and improved cerebral perfusion on SPECT. Eight patients with primary or secondary brain stem injury had worsening of a CSM component.

There was a significantly greater decrease in TFES in patients who had improved brain scans than in patients with no brain scan improvement. There are very limited data in pediatric patients. Neither objective measures nor parental reports indicated increased arousal associated with zolpidem administration. Conversely, increased sedation was noted.

PET scan results of regional perfusion during the zolpidem phase did not differ significantly from the placebo phase. Orally disintegrating tablets i. The recommended geriatric dose is 6. The recommended geriatric dose is 1. Avoid use as it may contribute to encephalopathy. It appears that no dosage adjustments are needed. Although evidence to date does not indicate any need to use lower doses of zolpidem in patients with renal impairment or renal failure, as a general precaution these patients should be closely monitored clinically.

Intermittent hemodialysis Zolpidem is not removed by hemodialysis. Based on limited study in end-stage renal disease patients on hemodialysis, it appears that no dosage accumulation occurs after 21 days of daily zolpidem administration. However, the manufacturers recommend close clinical monitoring of response to treatment as a general precaution. A MedGuide that provides information about proper use and risks of sedative-hypnotics should be dispensed with each new prescription and refill.

Food can decrease both the rate and extent of GI absorption; instruct patients to take zolpidem on an empty stomach to facilitate the onset of sleep. Formulations used for insomnia characterized by difficulty with sleep initiation i. Administer immediately before retiring. Formulations used for insomnia characterized by difficulty returning to sleep after a middle-of-the night awakening i.

Administer only if there are at least 4 hours of bedtime remaining before the planned time of waking. Swallow with a drink of water. For optimal effect, do not administer with or immediately after a meal. Extended-release tablet Ambien CR: Zolpidem tablets should not be chewed, broken, or crushed; they should be swallowed whole with a drink of water.

The tablet should be placed under the tongue where it can disintegrate; it should not be swallowed. Do not take with water. The sublingual tablet should be placed under the tongue where it can disintegrate; it should not be swallowed whole. The foil blister containing the tablet should be removed from exterior pouch just prior to dosing.

The manufacturer recommends leaving the empty pouch where it can be seen throughout the night as a reminder that a dose has been taken. This product should be used for middle-of-the night awakenings only when there is at least 4 hours of bedtime left before the planned time of waking. A Dosing Time Chart and a Dosing Time Tool are provided with the product as aides to the patient in determining the latest time during the night the product may be taken.

Refer to patient Instructions for Use included with package labeling for full instructions. Orally disintegrating tablet Tovalt ODT: This product is discontinued in the US. May be given with or without water. Place tablet in mouth where it can disintegrate and then be swallowed. Tablets should not be chewed, broken, or split. Zolpidem may be given with or without water. Oral pump must be primed 5 pump depressions prior to first use and re-primed 1 pump depression if not used for 14 or more days.

Spray dose directly into open mouth over the tongue. Do not inhale spray. Each spray provides 5 mg in microliters. Immediately repeat a second spray if the prescribed dose is 10 mg. Replace child-resistant cover after each use; store upright. There are 60 metered actuations in each container after the 5 initial priming actuations. Refer to Patient Instructions for Use included with package labeling for full instructions.

Zolpidem should be avoided in those with a hypersensitivity to zolpidem or any ingredient in the product. Reactions including anaphylaxis or angioedema may occur with sedative-hypnotics, and may become evident as early as the initial dose. Patients should be instructed on the appropriate action in the event of an allergic reaction.

Treatment with zolpidem should not be reinitiated in patients who experience angioedema after administration of the drug. Zolpidem, like all CNS depressants, should be used cautiously in patients with symptoms of depression. These patients may experience suicidal ideation and be more likely to intentionally overdose on medications. In addition, worsening of depression may occur during zolpidem administration.

Zolpidem should be prescribed in the smallest quantity consistent with good patient management to reduce the risk of overdose. Sleep disturbances may indicate an underlying physical or psychiatric problem. The failure of insomnia to remit after 7 to 10 days of zolpidem treatment may indicate the presence of a primary medical or psychiatric illness; therefore, evaluation for a potential co-morbid diagnosis is recommended at that time. Zolpidem has a rapid onset of action and causes CNS depression.

Zolpidem products indicated for insomnia due to difficulty with sleep initiation should only be administered immediately prior to retiring and with at least 7 to 8 hours remaining before the planned time of waking, and products indicated for difficulty returning to sleep after middle-of-the-night awakenings should only be taken while the patient is in bed and has at least 4 hours of bedtime remaining before the planned time of waking.

Patients should be instructed to avoid driving or operating machinery or performing other tasks requiring mental alertness for at least 8 hours after taking immediate-release formulations prior to retiring. Patients receiving the extended-release formulation should be cautioned against engaging in hazardous activities e. Patients receiving zolpidem for middle-of-the-night awakenings should 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.

Alterations in CNS functioning caused by zolpidem may lead to falls and subsequent severe injuries. Use of zolpidem has been associated with severe injuries such as hip fractures and intracranial hemorrhage. Due to gender differences in the elimination of zolpidem, a lower initial dose is recommended in adult females women. Plasma levels of zolpidem in some patients, particularly women, may be high enough the morning after use to impair activities requiring mental alertness, such as driving.

The risk for next-morning impairment is higher if zolpidem products for difficulty with sleep initiation e. Therefore, healthcare providers should caution all patients receiving zolpidem products about the risks of residual next-morning effects which may impair the ability to perform tasks requiring mental alertness, such as driving, even if the patient feels fully awake. Sedative-hypnotic medications can cause behavioral changes, including complex sleep-related behaviors such as phone calls, sexual activity, preparing and eating food, or sleep-driving, a state of driving after ingestion of a sedative-hypnotic while not fully awake and having no memory of the event or amnesia.

The exact incidences among various sedative products are unknown; however patients should be informed of the risks prior to receiving any medication from this class. Due to the risk to the patient and the general public, discontinuation of zolpidem should be strongly considered for patients who report a sleep-driving episode or other potentially harmful sleep-related complex behaviors. Concurrent alcohol use or coadministration with other CNS depressants increases the risk for CNS depression and complex sleep-related behaviors and other additive effects.

Patients taking zolpidem should avoid ethanol ingestion, such as alcoholic beverages and other alcohol-containing products. Lower initial dosages of zolpidem should be considered in patients taking other CNS-depressant therapies concurrently. Immediate-release zolpidem is recommended for use in the short-term treatment of insomnia.

No such recommendation exists in the package labeling for extended-release zolpidem, although cautious use is prudent when prescribing any hypnotic. Problems associated with abrupt discontinuation of hypnotic drugs are more likely to occur following chronic therapy. Rare postmarketing reports of abuse, dependence, and withdrawal have been received.

Withdrawal of some hypnotics also precipitates a rebound insomnia. If therapy is continued for more than 2 weeks the possibility of a withdrawal syndrome should be considered and abrupt discontinuation of therapy avoided. The possibility of physical and psychological dependence to zolpidem requires close monitoring. Zolpidem should be used cautiously in patients with a history of alcoholism or substance abuse.

Zolpidem should be administered cautiously to patients with hepatic disease because the elimination half-life of the drug can be prolonged, with possible resultant toxicity. Patients with hepatic insufficiency do not clear zolpidem as rapidly as patients with normal hepatic function. Patients with mild to moderate hepatic disease e. Avoid zolpidem use in patients with severe hepatic impairment e. Gamma-aminobutyric acid GABA agonists, such as zolpidem, have been associated with the development of hepatic encephalopathy in patients with hepatic insufficiency.

Postmarketing reports indicate that respiratory insufficiency or oxygen desaturation may occur in some patients treated with zolpidem, mostly in patients with pre-existing pulmonary disease. Zolpidem should be used with caution in patients with pre-existing respiratory depression, such as severe chronic obstructive pulmonary disease COPD , sleep apnea, or myasthenia gravis to avoid the risk of depressing ventilatory function.

Based on animal data, zolpidem may cause fetal harm and use during pregnancy is generally not recommended. There are no adequate and well-controlled studies in pregnant women, and animal study data are not always predictive of human response. Therefore, zolpidem should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonates may be adversely affected. Cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS-depressants.

Neonates born to mothers taking sedative-hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. One case report has documented the presence of zolpidem in human umbilical cord blood. Zolpidem has no established use during labor or obstetric delivery. Zolpidem is excreted in human milk, and caution should be used when the drug is administered during breast-feeding.

Three hours after drug administration, the mean milk to maternal plasma concentration ratio was 0. The amount of zolpidem measured in breast milk samples taken 3 hours after the dose represented 0. No detectable zolpidem was measured in subsequent milk samples taken at 13 and 16 hours after the dose. Breast-feeding was discontinued for 24 hours after drug administration; therefore, infant exposure was not assessed. The transfer of zaleplon, an alternative sedative, into breast milk has also been assessed; however, the effects of zaleplon exposure on the breast-feeding infant have also not been formally evaluated.

Lactating women should avoid breast-feeding their infants at times of peak drug concentrations, and observe the infant for any indications of adverse events, like sedation, increased crying, poor feeding, or irritability. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.

If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA. The safety and efficacy of zolpidem in pediatric patients have not been established and the drug cannot be recommended for use in children, adolescents or infants.

Studies of zolpidem in pediatric patients have not suggested efficacy of the drug over placebo, and, adverse events were frequent. Results of a controlled 8-week study for the treatment of insomnia in children aged 6 to 17 years with attention-deficit hyperactivity disorder ADHD indicated that zolpidem was not effective compared to placebo. One or more adverse events was experienced in In 3-week controlled trials, the adverse event profile of zolpidem extended-release was similar in elderly and younger adult populations.

However, the impairment of cognitive and motor function may be more marked in the elderly and a lower initial dosage is recommended together with close monitoring. No objective evidence of rebound insomnia was observed at recommended doses. According to the Beers Criteria, zolpidem is considered a potentially inappropriate medication PIM in geriatric patients and use should be avoided; benzodiazepine-receptor agonists such as zolpidem may produce similar adverse effects as benzodiazepines in older adults, such as falls, fractures, and delirium.

There are increased emergency department visits, hospitalizations, and motor vehicle crashes, as well as minimal improvement in sleep latency and duration in older adults. The Beers expert panel also recommends avoiding zolpidem in geriatric patients with dementia or cognitive impairment due to the potential for drug-induced adverse CNS effects, or those with delirium or at high risk of delirium since new-onset or worsening delirium may occur.

In addition, the Beers expert panel recommends avoiding zolpidem in elderly patients with a history of falls or fractures, unless safer alternatives are not available, since zolpidem can produce ataxia, impaired psychomotor function, syncope, and additional falls; if zolpidem must be used, consider reducing use of other CNS-active medications that increase the risk of falls and fractures and implement other strategies to reduce fall risk.

According to the OBRA guidelines, factors potentially causing insomnia should be evaluated before initiating a sedative e. Most cases of insomnia are associated with other underlying conditions. It is expected that non-pharmacologic interventions and maximized treatment of underlying conditions if applicable are implemented to address the causative factor s. Initiation of sleep induction or maintenance medication should be preceded or accompanied by other interventions to attempt sleep improvement.

The use of sedating medications for individuals with diagnosed sleep apnea requires careful assessment, documented clinical rationale, and close monitoring. Exceptions to the OBRA provisions include: OBRA provides dosing guidance for most sedatives, including zolpidem. When a drug is being used to induce sleep or treat a sleep disorder, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines.

Minor Caffeine is a central nervous system CNS stimulant. Patients taking medications for sleep, such as zolpidem should avoid caffeine-containing medications, dietary supplements, foods, and beverages within the hours close to bedtime. Patients should be encouraged to avoid excessive total daily caffeine intake, as part of proper sleep hygiene, since caffeine intake can interfere with proper sleep.

However, in healthy subjects without insomnia in a pharmacokinetic study, coadministration of caffeine at a dosage of to mg with zolpidem did not counteract the sedative effects of a single 10 mg dose of zolpidem. Major Concurrent use of zolpidem with barbiturates should be avoided if possible due to additive CNS depression. Sleep-related behaviors, such as sleep-driving, are more likely to occur during concurrent use of zolpidem and other CNS depressants than zolpidem alone.

Concurrent use of zolpidem with other sedative-hypnotics at bedtime or in the middle of the night is not recommended. Dosage reduction may be required for co-use in some patients. For example, a dosage reduction of the Intermezzo brand of sublingual zolpidem tablets to 1. Barbiturates are CYP3A4 enzyme inducers and may cause decreased plasma concentrations of zolpidem; in some patients efficacy may be reduced. CYP3A4 is the primary isoenzyme responsible for zolpidem metabolism, and there is evidence of significant decreases in systemic exposure and pharmacodynamic effects of zolpidem during coadministration of a potent CYP3A4 inducer.

Acetaminophen; Butalbital; Caffeine; Codeine: Moderate Concomitant use of zolpidem can potentiate the effects of codeine, which may potentially lead to respiratory depression, CNS depression, sedation, or hypotensive responses. In addition, sleep-related behaviors, such as sleep-driving, are more likely to occur during concurrent use of zolpidem and other CNS depressants than with zolpidem alone.

Prior to concurrent use, assess the level of tolerance to CNS depression that has developed, the duration of use, and the patient's overall response to treatment. Consider the patient's use of alcohol or illicit drugs. For Intermezzo brand of sublingual zolpidem tablets, reduce the dose to 1. Monitor patients for sedation and respiratory depression. Moderate Concomitant use of zolpidem can potentiate the effects of dihydrocodeine, which may potentially lead to respiratory depression, CNS depression, sedation, or hypotensive responses.

Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Moderate The CNS-depressant effects of zolpidem can be potentiated with concomitant administration of other drugs known to cause CNS depression, such as sedating H1-blockers. A dose reduction of either or both drugs should be considered to minimize additive sedative effects.

The risk of next-day psychomotor impairment is increased during co-administration, which may decrease the ability to perform tasks requiring full mental alertness such as driving. Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine: Moderate Concomitant use of hydrocodone with zolpidem may lead to hypotension, profound sedation, coma, respiratory depression and death.

Also consider a using a lower dose of zolpidem. Hypotension, profound sedation, coma, respiratory depression, or death may occur. Monitor for sedation and respiratory depression. Moderate Concomitant use of pentazocine with zolpidem can potentiate respiratory depression, CNS depression, and sedation. Pentazocine should be used cautiously in any patient receiving zolpidem. If concurrent use is necessary, a dose reduction of one or both medications may be required.

Moderate Concomitant use of CNS depressants can potentiate the effects of codeine, which may potentially lead to respiratory depression, CNS depression, sedation, or hypotensive responses. Moderate Extreme caution is needed in using tramadol at the same time as zolpidem. Sleep-related behaviors, such as sleep-driving, are more likely to occur during concurrent use of zolpidem and ethanol or other CNS depressants like tramadol than with zolpidem alone.

In addition, tramadol use increases the risk of CNS depression and respiratory depression when used with other agents that are CNS depressants. A reduced dose of tramadol is recommended when used with another CNS depressant. A dosage reduction of the Intermezzo brand of sublingual zolpidem tablets to 1. Therefore, psychotropic pharmacodynamic interactions could occur following concomitant administration of drugs with significant CNS activity.

Moderate Concomitant use of alfentanil with zolpidem can potentiate the effects of alfentanil on respiration, CNS depression, sedation, and hypotension. Both the magnitude and duration of CNS and cardiovascular effects may be enhanced. Postoperative respiratory depression associated with alfentanil may also be augmented. If used together, a reduction in the dose of one or both drugs may be needed.

Moderate Concomitant administration of benzodiazepines with zolpidem can potentiate the CNS effects e. Concurrent use of zolpidem with other sedative-hypnotics, including other zolpidem products, at bedtime or the middle of the night is not recommended. Moderate It is advisable to closely monitor zolpidem tolerability and safety during concurrent use of amiodarone, a moderate CYP3A4 inhibitor, since CYP3A4 is the primary isoenzyme responsible for zolpidem metabolism.

There is evidence of an increase in pharmacodynamic effects and systemic exposure of zolpidem during co-administration with some potent inhibitors of CYP3A4, such as azole antifungals. Moderate Zolpidem appears to interact with tricyclic antidepressants and may cause decreased alertness. In rare case reports, zolpidem has caused visual hallucinations or loss of alertness when these drugs e. Interactions with other tricyclic antidepressants have not been studied, but additive drowsiness is also possible.

Additionally, sleep-related behaviors, such as sleep-driving, are more likely to occur during concurrent use of zolpidem and other CNS depressants than with zolpidem alone. Moderate CNS depressants should be combined cautiously with amoxapine because they could cause additive depressant effects and possible respiratory depression or hypotension.

Major It is advisable to closely monitor zolpidem tolerability and safety during co-administration of potent CYP3A4 inhibitors, such as clarithromycin, and consider using a lower dose of zolpidem to minimize the potential for adverse CNS effects. CYP3A4 is the primary isoenzyme responsible for zolpidem metabolism, and there is evidence of an increase in pharmacodynamics effects and systemic exposure of zolpidem during co-administration with some potent inhibitors of CYP3A4, such as azole antifungals.

Major It is advisable to closely monitor zolpidem tolerability and safety during co-administration of potent CYP3A4 inhibitors, such as anti-retroviral protease inhibitors, and consider using a lower dose of zolpidem to minimize the potential for adverse CNS effects. Major Coadministration of zolpidem with apalutamide is not recommended due to decreased plasma concentrations of zolpidem. Moderate Apomorphine causes significant somnolence.

Concomitant administration of apomorphine and CNS depressants could result in additive depressant effects. A reduction in the dose of one or both drugs should be considered to minimize additive sedative effects. In addition, the risk of next-day psychomotor impairment is increased during co-administration of eszopiclone and other CNS depressants, which may decrease the ability to perform tasks requiring full mental alertness such as driving.

Minor No specific drug interactions were identified with systemic agents and apraclonidine during clinical trials. Theoretically, apraclonidine might potentiate the effects of CNS depressant drugs such as the anxiolytics, sedatives, and hypnotics, including barbiturates or benzodiazepines. Moderate Use caution if zolpidem and a multi-day regimen of oral aprepitant are used concurrently and monitor for an increase in zolpidem-related adverse effects for several days after administration.

Zolpidem is a CYP3A4 substrate. As a single mg or 40 mg oral dose, the inhibitory effect of aprepitant on CYP3A4 is weak, with the AUC of midazolam increased by 1. After administration, fosaprepitant is rapidly converted to aprepitant and shares many of the same drug interactions. However, as a single mg intravenous dose, fosaprepitant only weakly inhibits CYP3A4 for a duration of 2 days; there is no evidence of CYP3A4 induction.

Fosaprepitant mg IV as a single dose increased the AUC of midazolam given on days 1 and 4 by approximately 1. Less than a 2-fold increase in the midazolam AUC is not considered clinically important. Moderate Additive CNS-depressant effects may occur with the atypical antipsychotics and zolpidem. Moderate It is advisable to closely monitor zolpidem tolerability and safety during concurrent use of cobicistat, a moderate CYP3A4 inhibitor, since CYP3A4 is the primary isoenzyme responsible for zolpidem metabolism.

There is evidence of an increase in pharmacodynamics effects and systemic exposure of zolpidem during co-administration with some potent inhibitors of CYP3A4, such as azole antifungals. Use caution during coadministration. Atropine; Hyoscyamine; Phenobarbital; Scopolamine: Moderate Scopolamine may cause dizziness and drowsiness.

Moderate An enhanced CNS depressant effect may occur when azelastine is combined with CNS depressants including anxiolytics, sedatives, and hypnotics. A reduction in the dose of these medications may be considered to minimize additive sedative effects, if they occur. With hypnotic medications, the risk of next-day psychomotor impairment is increased during co-administration of other CNS depressants, which may decrease the ability to perform tasks requiring full mental alertness such as driving.

Belladonna Alkaloids; Ergotamine; Phenobarbital: Moderate Concomitant use of zolpidem and opium can potentiate the effects of opium, which may potentially lead to respiratory depression, CNS depression, sedation, or hypotensive responses. Moderate CNS depressants, such as anxiolytics, sedatives, and hypnotics, can increase the sedative effects of benztropine. Moderate It is advisable to closely monitor for reductions in zolpidem efficacy during co-administration of moderate CYP3A4 inducers, such as bexarotene.

CYP3A4 is the primary isoenzyme responsible for zolpidem metabolism, and there is evidence of significant decreases in systemic exposure and pharmacodynamic effects of zolpidem during co-administration of rifampin, a potent CYP3A4 inducer. Major It is advisable to closely monitor zolpidem tolerability and safety during co-administration of potent CYP3A4 inhibitors, such as boceprevir, and consider using a lower dose of zolpidem to minimize the potential for adverse CNS effects.

Moderate It is advisable to closely monitor for reductions in zolpidem efficacy during co-administration of moderate CYP3A4 inducers, such as bosentan. Moderate Monitor for decreased efficacy of zolpidem if coadministration with brigatinib is necessary. Brigatinib may also decrease zolpidem exposure. Moderate Based on the sedative effects of brimonidine in individual patients, brimonidine administration has potential to enhance the CNS depressants effects of anxiolytics, sedatives, and hypnotics.

Moderate Drowsiness has been reported during administration of carbetapentane. Moderate If concurrent use of zolpidem and buprenorphine is necessary, consider a dose reduction of one or both drugs because of the potential for additive pharmacological effects. Sedation, coma, or respiratory depression may occur during co-administration. Prior to concurrent use of buprenorphine in patients taking a CNS depressant, assess the level of tolerance to CNS depression that has developed, the duration of use, and the patient's overall response to treatment.

Evaluate the patient's use of alcohol or illicit drugs. Monitor patients for sedation or respiratory depression. Moderate Rare cases of hallucinations have occurred when zolpidem was administered concurrently with bupropion. Dosage reductions in zolpidem may be needed if bupropion is used concurrently. Moderate The combination of buspirone and other CNS depressants can increase the risk for sedation. Moderate Concomitant use of butorphanol with other CNS depressants can potentiate the effects of butorphanol on respiratory depression, CNS depression e.

Butorphanol should be used cautiously in any patient receiving these agents, which may include zolpidem. A reduction in dose of the CNS depressant may also be needed. Concurrent use Intermezzo with other sedative-hypnotics, including other zolpidem products, at bedtime or the middle of the night is not recommended. Moderate Concomitant administration of metaxalone with other CNS depressants, such as certain sedatives and hypnotics, can potentiate the sedative effects of either agent.

Major Concurrent use of zolpidem with potent CYP3A4 inducers, such as carbamazepine, should be avoided if possible because decreased plasma concentrations of zolpidem are possible and efficacy may be reduced. CYP3A4 is the primary isoenzyme responsible for zolpidem metabolism, and there is evidence of significant decreases in systemic exposure and pharmacodynamics effects of zolpidem during co-administration of rifampin, a potent CYP3A4 inducer.

Moderate COMT inhibitors such as entacapone and tolcapone should be given cautiously with other agents that cause CNS depression, including zolpidem, due to the possibility of additive sedation. Sleep-related behaviors, such as sleep-driving, are also more likely to occur during concurrent use of zolpidem and CNS depressants than with zolpidem alone. If concurrent use is necessary, monitor for additive side effects. A reduction in the dose of one or both drugs may be needed.

Moderate Monitor for zolpidem-related adverse reactions if coadministration with ceritinib is necessary; exposure to zolpidem may increase. Major It is advisable to closely monitor zolpidem tolerability and safety during co-administration of potent CYP3A4 inhibitors, such as chloramphenicol, and consider using a lower dose of zolpidem to minimize the potential for adverse CNS effects.

Chlorpheniramine; Guaifenesin; Hydrocodone; Pseudoephedrine: Moderate Avoid coadministration of zolpidem and ciprofloxacin as the combination may potentially lead to an increase in zolpidem exposure. Ciprofloxacin is an inhibitor of both enzymes. Moderate Disorientation, delusions, or hallucinations have been reported rarely during co-administration of zolpidem and SSRIs e.

The duration of the visual hallucinations has ranged from 30 minutes to 7 hours. The mechanism for the interaction is thought to be pharmacodynamic in nature; therefore, a similar reaction is possible with other SSRIs such as citalopram. Moderate Concomitant administration of clobazam with other CNS depressant drugs including anxiolytics, sedatives, and hypnotics, can potentiate the CNS effects i. Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide: Moderate Because promethazine causes pronounced sedation, an enhanced CNS depressant effect or additive drowsiness may occur when it is combined with other CNS depressants including anxiolytics, sedatives, and hypnotics.

Co-administration of conivaptan with some CYP3A substrates has resulted in mean increases of 2 to 3 times the baseline AUC values of these substrates. According to the manufacturer of conivaptan, treatment with CYP3A substrates may be initiated no sooner than 1 week after completion of conivaptan therapy. If co-administration cannot be avoided, consider using a lower dose of zolpidem to minimize the potential for adverse CNS effects.

There is evidence of an increase in pharmacodynamic effects and systemic exposure of zolpidem during co-administration with some potent inhibitors of CYP3A4. Moderate Monitor for an increase in zolpidem-related adverse reactions, including excess sedation, if coadministration with crizotinib is necessary. A dose reduction of zolpidem may be necessary.

There is evidence of an increase in pharmacodynamic effects and systemic exposure of zolpidem during coadministration with some potent inhibitors of CYP3A4. Moderate Cyclobenzaprine may cause additive CNS depression if used concomitantly with other CNS depressants, such as anxiolytics, sedatives, and hypnotics. Combination therapy can cause additive effects of sedation and dizziness, which can impair the patient's ability to undertake tasks requiring mental alertness.

Dosage adjustments of either or both medications may be necessary. Moderate It is advisable to closely monitor for reductions in zolpidem efficacy during co-administration of moderate CYP3A4 inducers, such as dabrafenib. Major It is advisable to closely monitor zolpidem tolerability and safety during co-administration of potent CYP3A4 inhibitors, such as dalfopristin; quinupristin, and consider using a lower dose of zolpidem to minimize the potential for adverse CNS effects.

Moderate It is advisable to closely monitor zolpidem tolerability and safety during concurrent use of danazol, a moderate CYP3A4 inhibitor, since CYP3A4 is the primary isoenzyme responsible for zolpidem metabolism. Moderate Simultaneous use of dantrolene and other CNS depressants, such as anxiolytics, sedatives, and hypnotics, can increase CNS depression e. Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir: Moderate It is advisable to closely monitor for reductions in zolpidem efficacy during co-administration of moderate CYP3A4 inducers, such as deferasirox.

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