zolpidem 5mg قرص

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Zolpidem, also known as Ambien, is a hypnotic drug that was initially approved by the FDA in 1992 Label. Zolpidem improves sleep in patients with insomnia. It is aimed for use in patients with difficulties initiating sleep. This drug decreases the time to fall asleep (sleep latency), increases the duration of sleep, and decreases the number of awakenings during sleep in patients with temporary (transient) insomnia. It is available in both immediate acting and extended release forms Label, 17.

Its tolerability profile is favorable when administered according to the manufacturer’s instructions, with a low risk of drug withdrawal, drug dependence, and drug tolerance 6. In addition, zolpidem improves sleep quality in patients suffering from chronic insomnia and can show mild muscle relaxant properties 15. Research also shows that zolpidem is rapid and effective in restoring brain function for patients in a vegetative state following brain injury. This drug has the propensity to completely or partially reverse the abnormal metabolism of damaged brain cells after injury 15, 9.

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A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

zolpidem 5mg قرص

A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

This drug is indicated for the short-term treatment of insomnia in adults characterized by difficulties with sleep initiation Label.

Effects on the central nervous system (CNS)

This drug has CNS depressant effects, which may include somnolence, decreased alertness, sedation, drowsiness, dizziness, and other changes in psychomotor function Label. Due to the above effects, the FDA has recommended an initial dose of zolpidem (immediate-acting) is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening 14. Refer to product labeling for detailed information 17, Label.

Effects on memory

Controlled studies in adults using objective measures of memory demonstrated no significant evidence of next-day memory impairment after the administration of zolpidem. On the contrary, in a clinical study involving the administration of zolpidem doses of 10 and 20 mg, a marked reduction in a next-morning recall of information relayed to subjects during peak drug effect (90 minutes after dosing) was observed. These subjects experienced a condition known as anterograde amnesia. Subjective evidence from adverse event data has suggested that anterograde amnesia may occur after zolpidem administration, mainly at doses above 10 mg Label.

Effects on psychomotor function

This drug may cause decreased psychomotor performance. Additive psychomotor effects may occur with other drugs that cause depression of psychomotor function, including alcohol Label. Patients taking zolpidem should be cautioned against participating in hazardous activities or occupations requiring complete mental alertness or motor coordination, including operating machinery or driving a motor vehicle after ingesting the drug. Potential impairment of the performance of the above types of activities may also occur the day after zolpidem ingestion, especially at higher doses and ingestion of the extended-release form Label, 17.

Effects on insomnia and sleep stages

Evidence suggests that this drug is associated with minimal rebound insomnia. During clinical trials with patients using zolpidem on an ‘as-needed’ basis, zolpidem use resulted in global improvements in sleep 6. Zolpidem has been demonstrated to decrease sleep latency (the time it takes to fall asleep) for up to 35 days in controlled clinical studies Label. In studies measuring the percentage of sleep time spent in each sleep stage, zolpidem has primarily been shown to preserve sleep stages. Sleep time spent in stages 3 and 4 (deep sleep) was measured as similar to placebo with only minor and inconsistent changes in REM (paradoxical) sleep at the recommended dose Label.

Next-day residual effects

In 2013, the FDA issued a statement warning that patients who take zolpidem extended-release (Ambien CR)―either 6.25 mg or 12.5 mg―should not drive or participate in other activities requiring full mental alertness the day after taking the drug, due to the fact that zolpidem concentrations can remain increased the next day, and impair the ability to perform these activities 14, 17. Patients may decrease their risk of next-morning impairment by taking the lowest dose of their insomnia medicine that treats their symptoms, according to the FDA 16. Specific dosing recommendations for both men and women are included in this statement 14. This information is also available on product labeling 17, Label.

Rebound effects

There was no polysomnographic (objective) evidence of rebound insomnia at normal doses, in studies evaluating sleep on the nights following discontinuation of zolpidem tartrate. Subjective evidence of impaired sleep in the elderly on the first post-treatment night was observed at doses higher than the recommended 5mg dose for elderly patients Label.

Zolpidem, the active moiety of zolpidem tartrate, is a hypnotic substance with a chemical structure that is not related to the structure benzodiazepines, barbiturates, pyrrolopyrazines, pyrazolopyrimidines or other drugs exerting hypnotic effects. It interacts with a GABA-BZ receptor complex and shares various pharmacological properties with the benzodiazepine class of drugs Label.

Subunit binding of the GABAA receptor chloride channel macromolecular complex is thought to lead to the sedative, anticonvulsant, anxiolytic, and myorelaxant drug effects of zolpidem. The main regulatory site of the GABAA receptor complex can be found on its alpha (α) subunit and is called the benzodiazepine (BZ) or omega (ω) receptor. At least three different subtypes of the (ω) receptor have been identified to this date Label.

In contrast to benzodiazepine drugs, which are found to modulate all benzodiazepine receptor subtypes in a non-selective fashion, zolpidem binds the (BZ1) receptor specifically with a potent affinity for the alpha 1/alpha 5 subunits (in vitro) Label. More recent studies suggest that zolpidem binds primarily to the alpha 1, 2, and 3 subunits of the GABA receptor 11, 12, 13, and not the alpha 5 subunit.

The (BZ1) receptor is found primarily on the Lamina IV of the brain sensorimotor cortical regions, substantia nigra (pars reticulata), cerebellum molecular layer, olfactory bulb, ventral thalamic complex, pons, inferior colliculus, and globus pallidus. Specific and selective binding of zolpidem on the (BZ1) receptor is not considered absolute, however, this binding could potentially explain the relative lack of myorelaxant and anticonvulsant activity in animal studies in addition to the preservation of deep sleep (stages 3 and 4) in human studies of zolpidem at hypnotic doses Label.

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Zolpidem is rapidly absorbed from the gastrointestinal tract. In a single-dose crossover study in 45 healthy subjects given 5 and 10 mg zolpidem tartrate tablets, the average peak zolpidem concentrations (Cmax) were 59 and 121 ng/mL, respectively, occurring at a mean time (Tmax) of 1.6 hours for both doses Label.

0.54 to 0.68 L/kg (in humans) 7. In patients with long term renal insufficiency who were not yet on hemodialysis, the volume of distribution was found to increase significantly, AUC increased by 60%, and half-life nearly doubled 7.

92.5 ± 0.1% Label

Zolpidem is metabolized to three pharmacologically by various hepatic cytochrome P450 (CYP) isoenzymes, mainly CYP3A4, but also CYP1A2 and CYP2C9 7, 10.
Although zolpidem is heavily metabolized, all three metabolites are inactive 6.

The major metabolic routes in humans are oxidation of the methyl group on the phenyl ring or the methyl group on the imidazopyridine moiety, to produce carboxylic acids (metabolites I and II), and hydroxylation of one of the imidazopyridine groups (to produce metabolite X). Another less common pathway is by the oxidation of the methyl groups on the substituted amide 7.

Zolpidem tartrate tablets are converted to inactive metabolites that are eliminated mainly by renal excretion Label.

The average zolpidem elimination half-life was 2.6 and 2.5 hours, for the 5 and 10 mg tablets, respectively Label.

In a clinical trial, after a 20mg dose, total clearance of zolpidem 0.24 to 0.27 ml/min/kg 7.

Oral (male rat) LD50 = 695 mg/kg MSDS.

Overdose

Symptoms of overdose include impairment of consciousness ranging from somnolence to light coma, in addition to cardiorespiratory collapse resulting in fatal outcomes have been reported Label.

Withdrawal effects

Following rapid decreases in dose or abrupt discontinuation of zolpidem and other sedative/hypnotics, reports of signs and symptoms similar to those associated with withdrawal from other CNS-depressant drugs have been made Label.

zolpidem 5mg قرص

Carcinogenesis

Zolpidem was administered to rats and mice over a span of 2 years at dietary dosages of 4, 18, and 80 mg/kg/day. In mice, these doses are considered 26 to 520 times or 2 to 35 times the maximum 10 mg human dose, respectively. In rats, these doses are 43 to 876 times or 6 to 115 times the maximum 10 mg human dose. No evidence of carcinogenicity was seen in mice. Renal liposarcomas were observed in 4/100 rats (3 males, 1 female) receiving 80 mg/kg/day, and a renal lipoma was observed in one male rat at the 18 mg/kg/day dose. Incidence rates of lipoma and liposarcoma for zolpidem were similar to those seen in historical control cases, and the tumor findings are presumed to be a spontaneous occurrence, not causally related to zolpidem Label.

Mutagenesis

Zolpidem did not show mutagenic activity in several tests including the Ames test, genotoxicity in mouse lymphoma cells in vitro, chromosomal aberrations in cultured human lymphocytes, abnormal DNA synthesis in rat hepatocytes in vitro, and the micronucleus test performed in mice Label.

Impairment of fertility

In a rat reproduction study, the high dose (100 mg base/kg) of zolpidem lead to irregular estrus cycles and prolonged precoital intervals, however, there was no effect on male or female fertility after daily oral doses comparable to 5 to 130 times the recommended human dose. No effects on any other fertility parameters were observed Label.

Use in pregnancy

This drug is considered a pregnancy category C drug. There are currently no sufficient conclusive studies completed in pregnant women to determine the safety of zolpidem use during pregnancy. Zolpidem should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Use in nursing

From 0.004% to 0.019% of the total administered zolpidem dose is excreted into milk. The effect of zolpidem on the nursing infant is unknown at this time. Caution should be observed when zolpidem is administered to a nursing mother Label.

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Markus Sauter, “Process for preparing zolpidem.” U.S. Patent US20020183522, issued December 05, 2002.

The date on which a patent was filed with the relevant government.

There is additional data available for commercial users including Adverse Effects, Contraindications, and Blackbox Warnings. Contact us to learn more about these and other features.

Drug created on June 13, 2005 07:24 / Updated on August 10, 2019 17:05

Generic Name: zolpidem (zole PI dem)Brand Names: Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist

Medically reviewed by P. Thornton, DipPharm Last updated on Dec 12, 2018.

Zolpidem is a sedative, also called a hypnotic. It affects chemicals in the brain that may be unbalanced in people with sleep problems (insomnia).

Zolpidem is used to treat insomnia. The immediate-release forms are Ambien, Intermezzo, Edluar, and Zolpimist, which are used to help you fall asleep. The extended-release form of zolpidem is Ambien CR which has a first layer that dissolves quickly to help you fall asleep, and a second layer that dissolves slowly to help you stay asleep.

Ambien, Edluar, and Zolpimist are used to help you fall asleep when you first go to bed. Intermezzo, is used to help you fall back to sleep if you wake up in the middle of the night and then have trouble sleeping.

zolpidem 5mg قرص

Your doctor will determine which form of zolpidem is best for you.

Zolpidem may cause a severe allergic reaction. Stop taking zolpidem and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Do not share this medication with another person, even if they have the same symptoms you have. The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children. Misuse of this medication can result in dangerous side effects.

Zolpidem may impair your thinking or reactions. You may still feel sleepy the morning after taking this medicine, especially if you take the extended-release tablet, or if you are a woman. Wait at least 4 hours or until you are fully awake before you do anything that requires you to be awake and alert.

Never take this medicine in larger amounts or for longer than prescribed.

Do not take zolpidem if you have consumed alcohol during the day or just before bed.

Some people using zolpidem have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking zolpidem and talk with your doctor about another treatment for your sleep disorder.

You should not use this medicine if you are allergic to zolpidem. The tablets may contain lactose. Use caution if you are sensitive to lactose.

Zolpidem is not approved for use by anyone younger than 18 years old.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

depression, mental illness, or suicidal thoughts;

drug or alcohol addiction;

lung disease or breathing problems;

sleep apnea (breathing stops during sleep); or

liver or kidney disease.

Taking zolpidem in the last 3 months of pregnancy may cause drowsiness or breathing problems in your newborn.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

The recommended doses of zolpidem are not the same in men and women, and this drug is not approved for use in children.

Take zolpidem exactly as prescribed by your doctor, Follow the directions on your prescription label and read all medication guides. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more or increase your dose.

Zolpidem may be habit-forming. Misuse can cause addiction, overdose, or death. Selling or giving away this medicine is against the law.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Never take Ambien, Edluar, or Zolpimist if you do not have a full 7 to 8 hours to sleep before being active again.

Do not take Intermezzo for middle-of-the-night insomnia unless you have 4 hours of sleep time left before being active.

Zolpidem is for short-term use only. Tell your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medication in a place where others cannot get to it. Keep the Zolpimist bottle upright when not in use.

Do not stop using zolpidem suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Insomnia symptoms may also return after you stop taking zolpidem, and may be even worse than before. Call your doctor if you still have worsened insomnia after the first few nights without taking zolpidem.

Zolpidem dosage information (in more detail)

Since zolpidem is taken only at bedtime if needed, you are not likely to miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zolpidem can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include sleepiness, confusion, shallow breathing, feeling light-headed, fainting, or coma.

Avoid taking zolpidem during travel, such as to sleep on an airplane. You may be awakened before the effects of the medicine have worn off. Amnesia (forgetfulness) is more common if you do not get a full 7 to 8 hours of sleep after taking this medicine.

Avoid driving or hazardous activity until you know how zolpidem will affect you. You may still feel sleepy in the morning, and your reactions could be impaired. Wait until you are fully awake before you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

Do not take this medicine if you have consumed alcohol during the day or just before bed.

Zolpidem may cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to zolpidem: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Report any new or worsening symptoms to your doctor, such as: depression, anxiety, aggression, agitation, confusion, unusual thoughts, hallucinations, memory problems, changes in personality, risk-taking behavior, decreased inhibitions, no fear of danger, or thoughts of suicide or hurting yourself.

Stop using this medicine and call your doctor at once if you have:

chest pain, fast or irregular heartbeat, feeling short of breath;

trouble breathing or swallowing; or

feeling like you might pass out.

The sedative effect of zolpidem may be stronger in older adults.

Dizziness or severe drowsiness can cause falls, accidents, or severe injuries.

Common zolpidem side effects may include:

daytime drowsiness, dizziness, weakness, feeling “drugged” or light-headed;

tired feeling, loss of coordination;

stuffy nose, dry mouth, nose or throat irritation;

nausea, constipation, diarrhea, upset stomach; or

headache, muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Zolpidem side effects (in more detail)

Usual Adult Dose for Insomnia:

IMMEDIATE RELEASE (IR) TABLET, ORAL SPRAY, and SUBLINGUAL TABLET (EDLUAR):
-Initial Dose: 5 mg (Women) OR 5 mg or 10 mg (Men)
-Maintenance Dose: The dose may be increased to 10 mg if the 5 mg dose is not effective.
-Maximum Dose: 10 mg once a day.
-Duration of Therapy: The clinical trials in support of efficacy were 4 to 5 weeks in duration.

CONTROLLED/EXTENDED RELEASE (CR/ER) TABLET:
-Initial Dose: 6.25 mg (Women) OR 6.25 mg or 12.5 mg (Men)
-Maintenance Dose: The dose may be increased to 12.5 mg if the 6.25 mg dose is not effective.
-Maximum Dose: 12.5 mg once a day.
-Duration of Therapy: The clinical trials in support of efficacy were up to 3 and 24 weeks in duration.

SUBLINGUAL TABLET (INTERMEZZO):
-Initial and Maximum Dose: 1.75 mg (Women) OR 3.5 mg (Men)

Comments: The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.

Use:
-IR Tablet, Oral Spray, and Sublingual Tablet (Edluar): Short-term treatment of insomnia characterized by difficulties with sleep initiation.
-CR/ER Tablet: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).
-Sublingual Tablet (Intermezzo): As needed treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Usual Geriatric Dose for Insomnia:

-IMMEDIATE RELEASE TABLET, ORAL SPRAY, and SUBLINGUAL TABLET (EDLUAR): 5 mg
-EXTENDED RELEASE TABLET: 6.25 mg
-SUBLINGUAL TABLET (INTERMEZZO): Men and Women Over the Age of 65 Years: 1.75 mg

Usual Pediatric Dose for Insomnia:

Not recommended.

Using zolpidem with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with zolpidem, making it less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Zolpidem drug interactions (in more detail)

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use zolpidem only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2019 Cerner Multum, Inc. Version: 12.01.

Medical Disclaimer

Other brands: Ambien, Ambien CR, Intermezzo, Zolpimist, Edluar

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Zolpidem is a prescription drug that comes as an oral tablet and an oral spray.

The oral tablet comes in three forms: immediate-release, extended-release, and sublingual. The immediate-release form releases the drug into your body right away. The extended-release form releases the drug into your body slowly. The sublingual tablet dissolves under your tongue.

These forms are available as the following brand-name drugs:

All forms of zolpidem oral tablets are also available as generic drugs. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Zolpidem oral tablets are used to treat insomnia. Insomnia causes trouble falling asleep or staying asleep.

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The immediate-release tablets and Edluar sublingual tablets are used if you have trouble falling asleep. The extended-release tablets are used if you have trouble falling asleep or staying asleep.

The low-dose (1.75-mg and 3.5-mg) sublingual tablets are used when you wake up in the middle of the night and have trouble falling back to sleep.

Zolpidem belongs to a class of drugs called sedatives. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Zolpidem increases the activity of GABA. GABA is a chemical in your body that causes sleepiness. Increasing its activity helps you fall asleep.

Zolpidem can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking zolpidem. This list does not include all possible side effects.

For more information on the possible side effects of zolpidem, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

The more common side effects of zolpidem can include:

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

Zolpidem oral tablet can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Below is a list of medications that can interact with zolpidem. This list does not contain all drugs that may interact with zolpidem.

Before taking zolpidem, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Taking zolpidem with certain medications raises your risk of side effects. This is because zolpidem and these other medications can cause the same side effects. As a result, these side effects can be increased. Examples of these drugs include:

Taking zolpidem with certain medications raises your risk of side effects from zolpidem. This is because the amount of zolpidem in your body may be increased. Examples of these drugs include:

When zolpidem is used with certain drugs, it may not work as well to treat your condition. This is because the amount of zolpidem in your body may be decreased. Examples of these drugs include:

The zolpidem dosage your doctor prescribes will depend on several factors. These include:

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Generic: Zolpidem

Brand: Ambien

Brand: Ambien CR

Brand: Edluar

Brand: Intermezzo

Adult dosage (ages 18–64 years)

Ambien, Edluar, and generic formulations:

Child dosage (ages 0–17 years)

This medication hasn’t been studied in children. It shouldn’t be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

The liver of an older adult may not work as well as it used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects. Your doctor may start you on a lowered dosage or a different treatment schedule. This can help keep levels of this drug from building up too much in your body.

Special dosage considerations for people with liver disease

Adult dosage (ages 18–64 years)

Ambien CR and generic extended-release oral tablets only:

Child dosage (ages 0–17 years)

This medication hasn’t been studied in children. It shouldn’t be used in people younger than 18 years.

zolpidem 5mg قرص

Senior dosage (ages 65 years and older)

Special dosage considerations for people with liver disease

Adult dosage (ages 18–64 years)

Intermezzo and generic low-dose sublingual tablets:

Child dosage (ages 0–17 years)

This medication hasn’t been studied in children. It shouldn’t be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

Special dosage considerations for people with liver disease

Zolpidem oral tablet comes with several warnings.

If you take zolpidem and don’t get a full night’s sleep, you may have decreased awareness and slower reaction times the next day. This may cause trouble driving. You shouldn’t drive or do other activities that require alertness if you take this drug and don’t get a full night’s sleep.

If you’re taking Intermezzo, you shouldn’t drive or do activities that require alertness without getting at least 4 more hours of sleep after taking it.

This drug may cause changes in behavior, such as increased agitation. You may act differently. You may act more outgoing, hallucinate (see or hear things that aren’t real), or feel like you’re watching yourself from outside of your body. You also may sleep-drive or do other activities in your sleep that you can’t remember later.

Tell your doctor if any of this happens to you.

Don’t stop taking this drug without talking to your doctor. If you’ve been taking this medication for a while and stop taking it suddenly, you may have withdrawal.

Symptoms can include muscle cramps, vomiting, sweating, flushing (reddening and warming of your skin), and emotional changes. These can include feelings of nervousness, panic attacks, and uncontrollable crying.

Zolpidem can cause a severe allergic reaction. Symptoms can include:

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Eating food with zolpidem may make the drug take longer to work. You should take this drug on an empty stomach.

Drinking alcohol can increase your risk of sedation and drowsiness from zolpidem. You shouldn’t take this drug on nights when you drink alcohol. If you drink alcohol, talk to your doctor. You may need to be monitored more closely for side effects.

For people with depression: This drug may make your symptoms of depression worse. Ask your doctor if this drug is safe for you.

For people with myasthenia gravis: This drug may slow your breathing or make it shallow. This can decrease the amount of oxygen in your blood. If you have myasthenia gravis, you may already have lower oxygen levels. Ask your doctor if this drug is safe for you.

For people with sleep apnea: This drug may slow your breathing or make it shallow. This can decrease the amount of oxygen in your blood. If you have sleep apnea, you may already have lower oxygen levels. Ask your doctor if this drug is safe for you.

For people with liver disease: If you have liver problems or a history of liver disease, you may not be able to process this drug well. This may increase the levels of the drug in your body and cause more side effects. It may also cause a serious condition called hepatic encephalopathy. With this condition, the poor function of your liver causes problems with the way your brain works. Symptoms can include being confused, forgetting things, and slurring your speech. If you have severe liver damage, you should not use zolpidem.

For pregnant women: There haven’t been enough studies done in humans to be certain how the drug might affect the fetus. Research in animals has shown negative effects to the fetus when the mother takes zolpidem. But animal studies don’t always predict how humans would respond.

Studies have shown that when mothers take this drug late in their third trimester, their newborns can have slowed breathing and excessive sleepiness. Your doctor will monitor your newborn closely if exposure to zolpidem occurred during your pregnancy.

This drug should only be used if the potential benefit justifies the potential risk. Talk to your doctor if you’re pregnant or plan to become pregnant. And call your doctor right away if you become pregnant while taking this drug.

For women who are breastfeeding: Zolpidem may pass into breast milk and cause side effects in a child who is breastfed. Talk to your doctor about breastfeeding your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

For seniors: The liver of an older adult may not work as well as it used to. This can cause your body to process drugs more slowly. As a result, more of a drug stays in your body for a longer time. This raises your risk of side effects, such as sedation and decreased alertness. You may also be more sensitive to these effects. If you’re over the age of 65 years, your doctor may give you a lower dosage of this drug.

For children: This drug hasn’t been studied in children. It shouldn’t be used in people younger than 18 years.

Zolpidem oral tablet is used for short-term treatment. It comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all: If you don’t take this drug, you’ll still have trouble falling or staying asleep. If you’ve been taking this medication for a while and stop taking it suddenly, you may have signs of withdrawal.

Withdrawal symptoms can include muscle cramps, vomiting, sweating, flushing (reddening and warming of your skin), and emotional changes. These can include nervousness, panic attacks, or uncontrollable crying. Never stop taking this drug without talking to your doctor.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose:

How to tell if the drug is working: You should have an easier time falling asleep and staying asleep.

Keep these considerations in mind if your doctor prescribes zolpidem oral tablet for you.

A prescription for this medication is refillable. Since zolpidem is a Schedule IV controlled substance, your doctor may refill this medication up to five times in 6 months. Your doctor will write the number of refills authorized on your prescription.

When traveling with your medication:

You and your doctor should monitor certain health issues during your treatment. This can help make sure you stay safe while you take this drug. These issues include:

Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.

Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

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N,N-Dimethyl-2-(6-methyl-2-p-tolylimidazo[1,2-a]pyridin-3-yl)acetamid (IUPAC)

Weißer Feststoff[1]

N05CF02

Hypnotika

fest

zolpidem 5mg قرص

196 °C (Zolpidem)[2]

6,2[3]

695 mg·kg−1 (LD50, Ratte, oral)[4]

Zolpidem ist ein Arzneistoff, der in Schlafmitteln bzw. Einschlafmitteln eingesetzt wird. Der Stoff ist strukturell ein Imidazopyridin-Abkömmling mit einem den Benzodiazepinen ähnlichem Wirkspektrum und zählt neben Zopiclon und Zaleplon zu den Z-Drugs. Zolpidem hat üblicherweise eine sehr kurze Halbwertszeit (2–3 Stunden) und keine pharmakologisch wirksamen Metaboliten. In vereinzelten Fällen werden jedoch auch bei weitem höhere Halbwertszeiten beobachtet (bis 10 Stunden). Es ist momentan das in den USA und in Europa meistverordnete Schlafmittel. Zolpidem wird vom Körper schnell und leicht aufgenommen, der maximale Plasmaspiegel wird nach etwa zwei Stunden erreicht. Vor allem wegen der Gefahr der Suchtentwicklung wird die Verordnung von Medikamenten, die Zolpidem enthalten, beispielsweise in Deutschland rechtlich eingeschränkt.

Zolpidem wirkt als positiver allosterischer Modulator an GABAA-Rezeptoren. Es bindet an die in der Extrazellulärdomäne gelegene hochaffine Benzodiazepin-Bindungsstelle dieses Ionenkanals. An ternären Rezeptoren bindet es an der Schnittstelle α1+γ2− und dabei selektiv an der alpha1-Untereinheit.[5] Zolpidem hat eine sedierende, muskelrelaxierende und antikonvulsive Wirkung. Es erleichtert das Einschlafen, die Dauer des Schlafes wird verlängert. Die Schlafarchitektur scheint durch Zolpidem bei niedriger Dosierung nicht nennenswert beeinflusst zu werden. Bei höheren Dosen treten Schlafveränderungen vergleichbar den durch Benzodiazepine hervorgerufenen auf.

23 Klinische Berichte und sechs Studien aus 15 Jahren belegen die Genesungseffekte von subsedativ-dosiertem Zolpidem bei Hirnschädigungen durch Schlaganfall, Trauma und Hypoxie, wie etwa unerwartetes Aufwachen aus dem Wachkoma und Besserung der Schlaganfallssymptome.[6] Wachkomapatienten waren nach der Einnahme des Mittels zeitweilig ansprechbar und reagierten auf ihre Umwelt. Zolpidem wirkt, anders als bisher bekannte GABAergika, an der Schnittstelle α1+α1− von binären GABAA-Rezeptoren.[7]

Zolpidem ist in Deutschland zugelassen zur Kurzzeitbehandlung von Schlafstörungen[8] und wird als weinsaures Salz (Zolpidemtartrat) in Form von Filmtabletten zu 5 mg oder 10 mg angewendet.

Aufgrund der notwendigen hohen Dosierungen für eine antikonvulsive und muskelrelaxierende Wirkung und der damit einhergehenden Nebenwirkungen wird Zolpidem für diese Indikationen nicht verwendet.

Zolpidem darf nicht angewendet werden bei krankhafter Muskelschwäche (Myasthenia gravis), bei schwerer Beeinträchtigung der Atmung, bei wiederholtem Aussetzen der Atmung während des Schlafes (Schlafapnoe-Syndrom), bei schweren Leberschäden sowie auch nicht bei Kindern und Jugendlichen unter 18 Jahren.[8]

Das Spektrum der Nebenwirkungen ähnelt dem der Benzodiazepine. Wie bei diesen kann es neben Müdigkeit, Dämpfung, Kopfschmerzen und Sehstörungen auch zu zeitlich begrenzten Gedächtnislücken (anterograde Amnesien), zu „paradoxen Reaktionen“ (Unruhe, Reizbarkeit, Aggressivität) als auch zu anderen Verhaltensstörungen sowie Sinnestäuschungen und Wahnvorstellungen kommen; das Risiko des Auftretens letzterer ist insbesondere bei höheren Dosen und bei älteren Patienten erhöht.

Wie durch die Verwandtschaft mit der Benzodiazepin-Gruppe zu erwarten, sind trotz der geringen Plasmahalbwertszeit Rebound-Phänomene, Toleranzentwicklung, physische und psychische Abhängigkeiten, sowie Entzugssymptome bei Therapiebeendigung möglich.[9][10][11] Aus diesem Grund sollte es nicht länger als wenige Tage verordnet werden. Das Risiko einer Abhängigkeit ist bei Patienten mit vorbestehender Abhängigkeitserkrankung erhöht.[8] In Kombination mit Alkohol oder anderen sedierend wirkenden Substanzen (insbesondere Benzodiazepinen) ist mit einer Verstärkung der Wirkung zu rechnen, weswegen die Tageshöchstdosis von 10 mg (Erwachsene) und 5 mg (ältere und geschwächte Patienten) nicht überschritten werden soll.[8] Insbesondere Frauen sind aufgrund geschlechtsspezifischer Unterschiede beim Abbau von Zolpidem über das Cytochrom-P450-System der Leber betroffen, da noch relevante Blutspiegel am Morgen nach der Einnahme bestehen können. Die amerikanische Zulassungsbehörde (FDA) empfiehlt, wegen des Risikos einer verzögerten Reaktionsfähigkeit am Morgen nach der Einnahme von Zolpidem auch in niedriger Dosierung (6,25 mg) kein Fahrzeug zu führen oder andere Tätigkeiten auszuüben, die ebenfalls volle geistige Wachheit erfordern.[12] Diese Empfehlungen wurden 2014 von der MHRA bestätigt.[13]

Zolpidem ist in Deutschland gemäß Anlage III zum Betäubungsmittelgesetz (BtMG) ein verschreibungsfähiges Betäubungsmittel. Ausgenommen sind Zubereitungen zur oralen Anwendung, die ohne einen weiteren Stoff der Anlage I bis III BtMG je abgeteilte Form nur bis zu 8,5 mg Zolpidem (berechnet als Base) enthalten und somit auf einem nichtamtlichen Rezeptformular verordnet werden dürfen.

In Österreich und in der Schweiz ist Zolpidem rezeptpflichtig.

Monopräparate: Ambien (USA), Bikalm (D), Ivadal (A), Mondeal (A), Stilnox (D, CH, I, F, E, GB, CZ), Zoldem (D, A), Zoldorm (CH), zahlreiche Generika (D, A, CH)