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Strength of ambien: Ambien (Zolpidem) Uses, Side Effects, Dosage, Overdose, Interactions

Zolpidem (Oral Route) Proper Use

Proper Use

Drug information provided by: IBM Micromedex

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Take zolpidem just before going to bed, when you are ready to go to sleep or when you are having trouble falling asleep. This medicine works very quickly to put you to sleep.

Swallow the extended-release tablet whole. Do not divide, crush, or chew it.

Do not take this medicine when your schedule does not permit you to get a full night’s sleep (7 to 8 hours). If you must wake up before this, you may continue to feel drowsy and may experience memory problems, because the effects of the medicine have not had time to wear off.

Take this medicine on an empty stomach.

Do not take this medicine if you have drank alcohol the same evening or just before bedtime.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For treatment of insomnia:


    • For oral dosage form (extended-release tablets):


      • Adults—6.25 milligrams (mg) (for women) or 6.25 or 12.5 mg (for men) once a day at bedtime. Your doctor may increase your dose as needed. However, do not take more than 12.5 mg per day. Take only 1 dose a night as needed.

      • Older adults—6.25 mg once a day at bedtime.

      • Children—Use is not recommended.

    • For oral dosage form (tablets):


      • Adults—5 milligrams (mg) for women and 5 or 10 mg for men once a day at bedtime. Your doctor may increase your dose as needed. However, do not take more than 10 mg per day. Take only 1 dose a night as needed.

      • Older adults—5 mg once a day at bedtime.

      • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Use this medicine only when you cannot sleep. You do not need to keep a schedule for taking it.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Portions of this document last updated: May 01, 2021

Copyright © 2021 IBM Watson Health. All rights reserved. Information is for End User’s use only and may not be sold, redistributed or otherwise used for commercial purposes.


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Questions and Answers: Risk of next-morning impairment after use of insomnia drugs; FDA requires lower recommended doses for certain drugs containing zolpidem (Ambien, Ambien CR, Edluar, and Zolpimist)

The U.S. Food and Drug Administration (FDA) is notifying the public of new information about zolpidem, a widely prescribed insomnia drug. FDA recommends that the bedtime dose be lowered because new data show that blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Today’s announcement focuses on zolpidem products approved for bedtime use, which are marketed as generics and under the brand names Ambien, Ambien CR, Edluar, and Zolpimist. 

FDA is also reminding the public that all drugs taken for insomnia can impair driving and activities that require alertness the morning after use. Drowsiness is already listed as a common side effect in the drug labels of all insomnia drugs, along with warnings that patients may still feel drowsy the day after taking these products. Patients who take insomnia drugs can experience impairment of mental alertness the morning after use, even if they feel fully awake.

FDA urges health care professionals to caution all patients (men and women) who use these zolpidem products about the risks of next-morning impairment for activities that require complete mental alertness, including driving. For zolpidem products, data show the risk for next-morning impairment is highest for patients taking the extended-release forms of these drugs (Ambien CR and generics). Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men.

Because use of lower doses of zolpidem will result in lower blood levels in the morning, FDA is requiring the manufacturers of Ambien, Ambien CR, Edluar, and Zolpimist to lower the recommended dose. FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). FDA also informed the manufacturers that, for men, the labeling should recommend that health care professionals consider prescribing the lower doses―5 mg for immediate-release products and 6.25 mg for extended-release products (see Zolpidem Dosing Recommendations for Adults).

The following questions and answers provide an overview of this safety issue.

Q1.  What is zolpidem?
Q2.  Why is FDA requiring the manufacturers of certain zolpidem-containing products to revise the labeling to lower the recommended dose of zolpidem for women and to recommend consideration of the lower dose in men?
Q3.  What should patients currently taking the 10 mg or 12.5 mg dose of zolpidem-containing insomnia medicines do now?
Q4.  Will a lower dose of zolpidem be effective in treating insomnia?
Q5.  Is FDA requiring the manufacturer of Intermezzo (zolpidem tartrate) sublingual tablets to also change the dosing recommendations?
Q6.  Do any other factors, such as a patient’s age, weight, or ethnicity, have an effect on zolpidem levels?
Q7.  Why is FDA informing the public about this safety risk now, after zolpidem has been on the market for nearly 20 years?
Q8.  Is next-morning impairment the same as complex sleep-related behaviors?
Q9.  Is FDA requiring the manufacturers of other insomnia medicines to revise their dosing recommendations?
Q10.   Do other insomnia medicines have the same gender effect as zolpidem?
Q11.  Do over-the-counter (OTC) insomnia medicines that are available without a prescription have a risk of next-morning impairment?
Q12.  What can patients do to decrease their risk of next-morning impairment with insomnia medicines?
Q13.  How many reports of zolpidem and impaired driving has FDA received? Were these reports used as evidence to support the proposed new dosing recommendations for certain zolpidem-containing products?

Q1.  What is zolpidem?

A.  Zolpidem is a sedative-hypnotic (sleep) medicine that is used in adults for the treatment of insomnia. Zolpidem is available as an oral tablet (Ambien and generics), an extended-release tablet (Ambien CR and generics), a sublingual (under-the-tongue) tablet (Edluar), and an oral spray (Zolpimist).

Zolpidem is also available under the brand name Intermezzo, a lower dose sublingual tablet that is approved for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.

Q2.  Why is FDA requiring the manufacturers of certain zolpidem-containing products to revise the labeling to lower the recommended dose of zolpidem for women and to recommend consideration of the lower dose in men?

A.  FDA is requiring the manufacturers of certain zolpidem-containing products to revise the labeling to lower the recommended dose of zolpidem-containing medicines for women and to recommend that health care professionals consider prescribing the lower dose for men because next-morning blood levels of zolpidem may be high enough to impair activities that require alertness, including driving. Patients with high levels of zolpidem can be impaired even if they feel fully awake. Zolpidem is eliminated from the body more slowly in women, so the drug can stay in their systems longer than it does in men.

Q3.  What should patients currently taking the 10 mg or 12.5 mg dose of zolpidem-containing insomnia medicines do now?

A.   If you are currently taking the 10 mg or 12.5 mg dose of zolpidem-containing insomnia medicine, continue taking your prescribed dose as directed until you have contacted your health care professional to ask for instructions on how to safely continue to take your medicine. Each patient and situation is unique, and the appropriate dose should be discussed with your health care professional.

Q4.  Will a lower dose of zolpidem be effective in treating insomnia?

A.  FDA has informed the manufacturers that the recommended dose of zolpidem for women should be lowered from 10 mg to 5 mg for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR). For men, FDA has informed the manufacturers that the labeling should recommend that health care professionals consider prescribing these lower doses. These lower doses of zolpidem (5 mg for immediate-release products and 6.25 mg for extended-release products) will be effective in most women and many men.

Q5.  Is FDA requiring the manufacturer of Intermezzo (zolpidem tartrate) sublingual tablets to also change the dosing recommendations?

A.  No. When Intermezzo was FDA-approved in November 2011, the label already recommended a lower dosage in women compared to men. The recommended and maximum dose of Intermezzo is 1.75 mg for women and 3.5 mg for men, taken only once per night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep.

Q6.  Do any other factors, such as a patient’s age, weight or ethnicity, have an effect on zolpidem levels?

A.  Based on data from pharmacokinetic trials, no relationship was evident between the zolpidem blood level and patients’ body weight or ethnicity. In elderly patients, zolpidem blood levels can be higher, and the lower doses are already recommended. In contrast to younger patients, zolpidem blood levels in elderly patients are not affected by gender.

Q7.  Why is FDA informing the public about this safety risk now, after zolpidem has been on the market for nearly 20 years?

A.  Since the approval of zolpidem, FDA has been continually monitoring the drug’s safety profile. As more data became available, FDA continued to assess the benefits and risks of zolpidem treatment. Over the years, FDA has received reports of possible driving impairment and motor vehicle accidents associated with zolpidem; however, in most cases it was difficult to determine if the driving impairment was related to zolpidem or to specific zolpidem blood levels because information about time of dosing and time of the impairment was often not reported. Recently, data from clinical trials and driving simulation studies have become available that allowed FDA to better characterize the risk of driving impairment caused by specific blood levels of zolpidem and to recognize the increased risk of driving-impairing blood levels of zolpidem in women. This led FDA to require the manufacturers of certain zolpidem-containing products to revise the dosing recommendations.

Q8.  Is next-morning impairment the same as complex sleep-related behaviors?

A.  No, they are different. Next-morning impairment occurs when patients are awake the next morning, but levels of the insomnia medicine in their blood remain high enough to impair activities that require alertness, including driving.

Complex sleep-related behaviors occur when patients get out of bed while not fully awake, and sleep walk or do an activity such as drive a car, prepare and eat food, make phone calls, or have sex.

Both problems are made worse by high levels of zolpidem. The changes that FDA is requiring to the dosing recommendations in the drug labeling are expected to decrease the risk of both next-morning impairment and complex sleep-related behaviors.

Q9.  Is FDA requiring the manufacturers of other insomnia medicines to revise their dosing recommendations?

A.   No. At this time, FDA is only requiring the manufacturers of certain zolpidem-containing products to revise their dosing recommendations.

FDA is continuing to evaluate ways to lower the risk of next-morning impairment with other insomnia medicines.

Q10.  Do other insomnia medicines have the same gender effect as zolpidem?

A.  FDA is currently evaluating other insomnia medicines to determine if they affect men and women differently.

Q11.  Do over-the-counter (OTC) insomnia medicines that are available without a prescription have a risk of next-morning impairment?

A.  Yes. OTC insomnia medicines also have a risk for next-morning impairment. FDA is not recommending that patients who are currently taking prescription insomnia medicines switch to OTC insomnia medicines.

Patients who drive or perform activities that require full alertness the next morning should discuss with their health care professional if the insomnia medicine they are using is right for them.

Q12.  What can patients do to decrease their risk of next-morning impairment with insomnia medicines?

A.  Patients can decrease their risk of next-morning impairment by taking the lowest dose of their insomnia medicine that treats their symptoms. It is important for patients to take their insomnia medicine exactly as prescribed. Taking a higher dose than prescribed or using more than one insomnia medicine is dangerous if patients drive or perform activities that require full alertness the next morning, even if the drugs are taken at the beginning of the night. In addition, patients should not take insomnia medicine intended for bedtime use if less than a full night’s sleep (7-8 hours) remains. Likewise, patients should not take Intermezzo, a zolpidem product that is approved for use in the middle of the night, if less than 4 hours of sleep remain.

Q13.  How many reports of zolpidem and impaired driving has FDA received? Were these reports used as evidence to support the proposed new dosing recommendations for certain zolpidem-containing products?

A.   FDA has received about 700 reports of zolpidem and “impaired driving ability and/or road traffic accident.” Following a zolpidem label change in 2007, which added information to the Warnings and Precautions section of the label about complex sleep-related behaviors, including sleep-driving (patients getting out of bed while not fully awake and driving), there was a great deal of media attention. Since such publicity tends to “stimulate” reporting, this led to the considerable number of reports of zolpidem and impaired driving that were submitted to FDA’s Adverse Event Reporting System (AERS) database.

However, while AERS reports generally can be helpful in evaluating safety concerns, these AERS reports for zolpidem lacked the information necessary to understand whether high morning blood levels of zolpidem were the cause of the reported impaired driving. Specifically, these reports often did not include the dose or time zolpidem was taken, the time of the accident, whether alcohol or other drugs were also taken, and whether and when blood levels of the drug were measured. It wasn’t until FDA received the new data on next-day blood levels and driving simulation studies that the apparent frequency of next-morning mental impairment was better identified.

Related Information

FDA Lowers Ambien Dosages | MedPage Today

WASHINGTON — Makers of sleep drugs containing zolpidem, including Ambien and Ambien CR, must cut the recommended dosages for women by half — to 5 mg for immediate-release products and 6.25 mg for extended-release formulations — to reduce morning drowsiness, the FDA announced Thursday.

Drug labeling should also recommend that healthcare professionals consider a lower dose for men, the agency said.

New data suggest that the drugs can leave levels of zolpidem high enough the morning after use to impair activities such as driving, the agency said.

The issue is especially acute in women, according to Ellis Unger, MD, director of the FDA’s Office of Drug Evaluation I.

“We’ve learned here, rather recently, that women appear to be more susceptible to the risk of next-morning impairment because they eliminate zolpidem from their bodies more slowly than men,” Unger told reporters in a telephone briefing.

The reason for the difference remains unclear, he said, adding it’s “unusual” to have dosing recommendations that differ by sex.

Besides the Ambien products, the dosage change applies to the Edluar and Zolpimist branded products, as well as generic formulations.

“Over the years,” Unger said, “we have received reports of possible driving impairment and motor vehicle accidents related to zolpidem.”

But, he added, in most cases data was so sketchy — lacking, for instance, information on blood levels of the drug or concomitant use of alcohol — that it was “very difficult to point your finger at zolpidem.”

For that reason, he said, the labeling changes are “not tied to any specific case or any specific reports of adverse events.

Instead, the changes are based on new evidence that, in some people, zolpidem levels the morning after use remain above 50 ng/mg of blood. Indeed, 8 hours after taking the extended release version of the drug, a quarter of men and a third of women had levels higher than that, Unger said.

And recent driving simulations, undertaken during the approval process for another zolpidem-containing drug, Intermezzo, suggested the 50 ng/mg level is high enough to cause impaired alertness.

“By cutting the dose in half, we really significantly reduce the numbers of people who have that kind of level,” he said.

New drugs under development will be required to carry out similar driving simulations as part of the approval process, Unger said, and makers of approved drugs will be asked to do so as well.

Unger also said that next-morning impairment is a common side effect of all insomnia drugs, and alertness can be impaired even when people don’t feel sleepy. The FDA is continuing to evaluate other sleep medications, he said.

Patients with a prescription for any of the drugs should continue to take them as prescribed, he said, until they can discuss the issue with their doctors.

Lunesta vs Ambien: Main Differences and Similarities

Lunesta and Ambien are two oral medications indicated to treat insomnia. Both medications are classified as non-barbiturate hypnotics. They work by interacting with GABA receptors in the brain to produce sedative and anxiolytic effects. Both medications are on the BEERS list where caution should be taken in elderly individuals over 65 years of age due to potential risks and side effects. While both medications produce similar effects, they do have some differences.

Lunesta

Lunesta is the brand name for eszopiclone. It reaches peak concentrations in the body at approximately 1 hour after oral administration. This time can be delayed if the medication is taken with a big meal. Therefore, it is not recommended to be taken with food.

Because Lunesta is metabolized in the liver to its active metabolite, S-zopiclone-N-oxide, it should not be taken with certain drugs that affect liver enzymes.

The half-life of Lunesta is approximately 6 hours in normal adults. However, in the elderly population, the half-life is increased which may cause increased drowsiness.

Lunesta is supplied as an oral tablet with strengths of 1 mg, 2 mg, and 3 mg.

Ambien

Ambien is the brand name for zolpidem tartrate. Similar to Lunesta, it reaches peak concentrations in the blood at 1.5 hours after oral administration.

Because it is extensively metabolized in the liver, it should not be taken with certain medications due to the increase of potential adverse effects. Dosage adjustments may be necessary for those with liver impairment.

Oral tablets come in strengths of 5 mg and 10 mg. Unlike Lunesta, there is also an extended release form available which can come in strengths of 6.25 mg or 12.5 mg.

Lunesta vs Ambien Side by Side Comparison

Both Lunesta and Ambien are nonbarbiturate hypnotics that have several similarities and differences. These similarities and differences can be found in the comparison below.

Lunesta Ambien
Prescribed For
Drug Classification
Manufacturer
Common Side Effects
  • Unpleasant taste
  • Dizziness
  • Dry mouth
  • Headache
  • Rash
  • Anxiety
  • Somnolence
  • Hallucinations
  • Viral infections
  • Respiratory infection
  • Drowsiness
  • Dizziness
  • Diarrhea
  • Grogginess
Is there a generic?
Is it covered by insurance?
  • Varies according to your provider
  • Varies according to your provider
Dosage Forms
  • Oral tablet
  • Oral tablet, extended release
Average Cash Price
SingleCare Discount Price
Drug Interactions
  • CNS depressants
  • Muscle relaxants
  • CYP3A4 inhibitors
  • Sodium oxybate
  • Medications that may cause drowsiness
  • CNS depressants
  • Muscle relaxants
  • CYP3A4 inhibitors
  • Sodium oxybate
  • Medications that may cause drowsiness
Can I use while planning pregnancy, pregnant, or breastfeeding?
  • Lunesta is in Pregnancy Category C. Consult a physician regarding taking Lunesta while pregnant or breastfeeding.
  • Ambien is in Pregnancy Category C. Consult a physician regarding taking Ambien while pregnant or breastfeeding.

Summary

Lunesta and Ambien are two medications that can treat insomnia. Although they work in similar ways, they do have some important distinctions. Ambien may be preferred because of its availability as a controlled-release formulation. This may help provide a longer sleep duration for individuals who wake up in the middle of the night, especially with the immediate release tablets.

Both Lunesta and Ambien are Schedule IV medications which may have the potential for abuse or dependence. For this reason, they should not be taken with other similar acting drugs that may cause drowsiness. Their use should also be cautioned in those with liver impairment due to their extensive metabolism in the liver. It is important to discuss your overall condition as well as other medications you take with a physician as one may be preferred over the other.

Generic Ambien®, Zolpidem Tartrate Extended-Release C-IV 12.5mg: Winthrop US

Please see the following for detailed product information. Use the dropdown menu for specific details about each available strength.

Brand Equivalent: Ambien CR® (zolpidem tartrate extended release)


Select Strength:
6.25 mg12.5 mg










NDC: 00955-1703-10
ABC Order #: 021949
Cardinal Order # 4360046
McKesson Order # 1101260
Form: Tablet
Strength: 12.5 mg
Package Size: 100
Case Quantity: 48
Controlled Substance: Yes





Package Description Length (in) Width (in) Height (in) Cube (ft3) Weight (lbs)
Single Unit: 5.56 0.75 3.00 0.007 0.05
Inner Unit: 5.75 4.75 3.25 0.051 0.32
Case Pack: 11.813 9.813 10.375 0.696 4.59

Zolpidem Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Read the Medication Guide provided by your pharmacist before you start taking zolpidem and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth on an empty stomach as directed by your doctor, usually once a night. Since zolpidem works quickly, take it right before you get into bed. Do not take it with or after a meal because it will not work as quickly.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Do not take a dose of this drug unless you have time for a full night’s sleep of at least 7 to 8 hours. If you have to wake up before that, you may have some memory loss and may have trouble safely doing any activity that requires alertness, such as driving or operating machinery. (See also Precautions section.)

Dosage is based on your gender, age, medical condition, other medications you may be taking, and response to treatment. Do not increase your dose, take it more often, or use it for longer than prescribed. Do not take more than 12.5 milligrams a day. Women are usually prescribed a lower dose because the drug is removed from the body more slowly than in men. Older adults are usually prescribed a lower dose to decrease the risk of side effects.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as nausea, vomiting, flushing, stomach cramps, nervousness, shakiness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used zolpidem for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists after 7 to 10 days, or if it worsens.

You may have trouble sleeping the first few nights after you stop taking this medication. This is called rebound insomnia and is normal. It will usually go away after 1-2 nights. If this effect continues, contact your doctor.

Ambien CR Dosage and Administration | Healthgrades

  • Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily (2.1)
  • Recommended initial dose is a single dose of 6.25 mg for women and a single dose of 6.25 or 12.5 mg for men, immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening (2.1)
  • Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for men and women (2.2)
  • Lower doses of CNS depressants may be necessary when taken concomitantly with AMBIEN CR (2.3)
  • Tablets to be swallowed whole, not to be crushed, divided or chewed (2.4)
  • The effect of AMBIEN CR may be slowed if taken with or immediately after a meal (2.4)

Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men, taken only once per night immediately before bedtime with at least 7–8 hours remaining before the planned time of awakening. If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 mg dose increase the risk of next-day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.2)]. The total dose of AMBIEN CR should not exceed 12.5 mg once daily immediately before bedtime. AMBIEN CR should be taken as a single dose and should not be readministered during the same night.

The recommended initial doses for women and men are different because zolpidem clearance is lower in women.

Elderly or debilitated patients may be especially sensitive to the effects of zolpidem tartrate. The recommended dose of AMBIEN CR in these patients is 6.25 mg once daily immediately before bedtime [see Warnings and Precautions (5.2), Use in Specific Populations (8.5)].

Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of AMBIEN CR in these patients is 6.25 mg once daily immediately before bedtime. Avoid AMBIEN CR use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions (5.8), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

Dosage adjustment may be necessary when AMBIEN CR is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.2)].

AMBIEN CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of AMBIEN CR may be slowed by ingestion with or immediately after a meal.

AMBIEN CR is available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored.

AMBIEN CR 6.25 mg tablets are pink, round, bi-convex, and debossed with A~ on one side.

AMBIEN CR 12.5 mg tablets are blue, round, bi-convex, and debossed with A~ on one side.

Extended-Release Tablets: 6.25 mg and 12.5 mg. Tablets not scored. (3)

In postmarketing experience of overdose with zolpidem tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported.

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.

AMBIEN CR 6.25 mg extended-release tablets are composed of two layers

and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as:

NDC Number Size
0024-5501-31 bottle of 100

AMBIEN CR 12.5 mg extended-release tablets are composed of two layers

and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as:

NDC Number Size
0024-5521-31 bottle of 100

Store between 15°C–25°C (59°F–77°F). Limited excursions permissible up to 30°C (86°F).

90,000 Sleeping pills helped a man with a brain injury walk and talk again. But not for long

Hisse Arnts et.al / Cortex, 2020

A Dutch physician described a case of short-term recovery of consciousness and physical activity in a patient with severe brain injury after taking a single dose of zolpidem.The effects only lasted about two hours, but this case may bring new data on possible treatments for brain damage from stroke and other injuries. Report submitted to Cortex log.

Zolpidem is usually prescribed as a sedative: it is a benzodiazepine drug, it works as an agonist of GABA receptors and, as a rule, has a calming effect on the central nervous system. Sometimes the drug has a paradoxical effect – some patients with certain neurological disorders who are in states like coma return to consciousness.However, until now, the strength of the effect from the use of the drug in comatose patients turned out to be not so significant.

A team of doctors led by Hisse Arnts of the University of Amsterdam Medical Center studied the case of a 35-year-old patient who had suffered serious brain damage eight years earlier. The man choked on a piece of meat that blocked the airways and for a long time limited the access of oxygen to the brain, which caused irreparable damage to his neurological functions.Although the patient showed some recovery and a certain level of awareness during the initial period after the accident, he soon stopped moving and speaking on his own. Moreover, the periods of wakefulness were very short. Over the next eight years, the man’s condition remained unchanged. To stay alive, he needed 24/7 care and tube feeding.

The doctors decided to give the patient a single dose of the drug zolpidem – 10 milligrams.Twenty minutes later, the man spoke to his father on the phone for the first time in eight years and was able, with the help of medical staff, to walk a little. He could not remember the details of the choking incident and had hearing problems, but was otherwise cheerful and showed clear contact with others, and at some point asked to bring him food.

The improvement lasted a little over an hour, after which the man gradually returned to the initial pathological level of activity of neurological functions.Within 24 hours, the patient was given repeated doses of zolpidem, with each time the periods of normalization became shorter until the drug ceased to work completely. In addition, doctors examined the man’s brain before and after taking the medication using EEG and MRI methods. The results showed that by acting similar to the main inhibitory neurotransmitter of the central nervous system (GABA), zolpidem soothes areas of the brain that have become overactive after injury and increases the electrical activity in the brain (beta waves) associated with wakefulness.

Comparison of the electrical activity of the patient’s brain before and after taking zolpidem.

Hisse Arnts et.al / Cortex, 2020

During the subsequent weekly experiment with the use of zolpidem, doctors determined that the most effective period of drug action lasts from 30 to 60 minutes.Currently, the patient receives zolpidem only on special occasions, for example, during a visit with relatives or when he needs to visit the dentist.

Reports that zolpidem restores consciousness in patients with neurological disorders are extremely rare, and the only case described is certainly not enough to talk about its introduction into medical practice to remove people from similar conditions. This requires a series of clinical trials on a large group of patients.For example, the authors of the article propose to conduct experiments with the use of zolpidem in combination with the technique of deep brain stimulation in order to consolidate the effects of the drug for a longer period.

Scientists have long been looking for potential cures for intractable brain diseases, as well as the possibility of treating and repairing complex injuries of the central nervous system. For example, we previously reported on the successful paired transcranial and peripheral stimulation of four nerves to recover from paralysis.And also about how the famous antibiotic was proposed to be used for the treatment of senile dementia. And here you can read the story of how a specialized experimental drug helped defeat a rare neurodegenerative disease in a child.

Alexey Kozlov

90,000 Elon Musk talked about implanting a chip from Neuralink in a monkey, which allows it to play video games “with the power of thought” Editorial articles

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And he called it “a happy monkey.”

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The founder of Tesla and SpaceX, Elon Musk, conducted a stream on the Clubhouse social network, where he was asked about the latest developments of the startup Neuralink, writes Bloomberg.

“We have a monkey with a wireless implant in its skull with tiny wires that can play video games with the power of thought,” Musk said. According to him, the monkey is “happy” and lives in “the best monkey conditions in the world.” “We want the monkeys to play intelligent ping-pong with each other,” he added.

Musk has promised that videos of monkeys playing video games will be released soon.

Neuralink startup was launched in 2016. According to Crunchbase, since its inception, Musk has invested $ 158 million in it. The purpose of the technology being developed is to eliminate the consequences of brain and spinal cord injuries and replenish lost abilities using an implanted chip.

In August 2020, Elon Musk showed the updated Neuralink neurointerface – a wireless Link chip in the shape of a coin. Musk said the Neuralink could be used to control games and promised the chip would support StarCraft.

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How are we treated for insomnia

The possibility of side effects, however, remains here.For Generation Z drugs, according to a review in the Journal of Medical Toxicology, these include decreased alertness and rare sleepwalking. Therefore, it is still better to take them under the supervision of a doctor and try not to drive a car. Only zaleplon does not have the last contraindication, which can even be taken by American aviation pilots just six hours before the flight (this is the shortest required period between the allowed taking of sleeping pills and going on the flight). None of the drugs in this group should be combined with alcohol.

Zaleplon’s action is the fastest (and ends the fastest). The effects and side effects of zolpidem and zopiclone are similar, but zopiclone (which usually costs much less) is more addictive if used for more than two weeks. In general, all three drugs are safest to use sporadically, rather than long-term – this will avoid dependence. Zopiclone does not help children with ADHD fall asleep, although it is safe for them. He also has a more pronounced sedative effect than his colleagues with the letter “z”.

Although “real” sleeping pills are dispensed according to a medical prescription, the patient needs to know about them: if you have chronic insomnia, and are prescribed only “mild” sedative herbs (like Novo-Passit), or recommend a regimen, perhaps this is a reason to change your doctor. Or it may mean that your case is not so serious and your doctor hopes that modifying your sleep conditions or a placebo effect can help you. The hypnotic effects of valerian, kava and chamomile extracts are statistically insignificant according to the Sleep Medicine Review.

Our advice cannot be equated with a doctor’s prescription. Before you start taking this or that drug, be sure to consult with a specialist.

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Sleep and wakefulness. Insomnia and sleeping pills

In all living things (from protozoa to humans), all organs and systems of the body function in accordance with circadian (from the Latin words “circa” – about and “dies” – day) or circadian rhythms.The most pronounced fluctuations in circadian rhythms during the transition of the body from sleep to wakefulness, and they also appear during sleep. The physiological significance of circadian rhythms in humans and animals lies not only in the regulation of the rhythmic activity of physiological functions and metabolism, but also in the interaction of the organism with the environment.

A waking person actively interacts with the environment. In the state of sleep, this interaction does not disappear, but it has a number of physiological differences.

Physiological (normal) sleep proceeds in several stages. In a healthy person, it begins from the so-called “relaxed wakefulness” (stage A), which corresponds to the transition from wakefulness to sleep. The man is in bed and getting ready for bed. Alpha waves are recorded on the encephalogram. Then comes the latent period of sleep (stage B, falling asleep and the most superficial sleep), characterized by the appearance of delta waves on the encephalogram. After this, superficial sleep occurs (stage C), when the sleeping person no longer responds to weak external stimuli.On the encephalogram, there are high-amplitude “vertex-teeth” with a duration of 3-5 s, as well as spindle-shaped bursts of rhythm – beta waves (“sleepy spindles”). Stage D (moderately deep sleep) is characterized by the appearance of fast beta waves on the encephalogram. In stage E (deep sleep), slow alpha waves are occasionally superimposed on slow beta waves. In stages D and B, there is a complete shutdown of consciousness, a significant decrease in pain sensitivity and tone of striated muscles, as well as a lack of response to strong stimuli.

Before awakening, a sleeping person usually goes through another, special phase of sleep, characterized by desynchronization of the encephalogram, as well as episodes of rapid eye movements with atony of the remaining striated muscles.

It should be emphasized that during the night there are four cycles of sleep phase changes.

Another feature of sleep physiology has been established – during sleep, some brain centers are at rest (inhibition), while others are in a state of excitement.

It is well known that sleep is a physiological state of the body and is vital for humans. During sleep, a person rests, recovers his strength, just during sleep, the processes of growth and normalization of metabolism are accelerated. There is a relationship between a child’s growth and sleep. Growth hormone is released during sleep. The longer the baby sleeps, the better it grows. If we add to this that a person spends a third of his life in a dream, then the vital necessity of sleep will become clear.

Studies conducted on animals have shown that deprivation of their sleep for three days or more leads not only to a disorder of the function of the nervous, cardiovascular, urinary systems, digestive organs, metabolism, but also to the development of degenerative (necrotic) changes in the structure of nerve cells.

Insomnia negatively affects the general state of the human body, reduces its ability to work, causes rapid fatigue, increased irritability, mental imbalance, leads to the development of a state of constant stress, inhibits the healing process in diseases of internal organs.Insomnia is one of the risk factors for the development of hypertension or ischemic disease, hypertensive crisis, and angina pectoris. Without a doubt, insomnia reduces the ability to work, the mental activity of a person, negatively affects the communication of a person in a team.

Therefore, sleep disorders are so difficult for patients, and this requires the use of hypnotics that can induce normal physiological sleep.

Restoration of physiological sleep is the main purpose of sleeping pills.Remedies for insomnia can not only normalize the patient’s sleep, but also improve the general condition of a person.

Scientists of the world have been searching for effective and safe sleeping pills for a long time. The first synthetic drug with a hypnotic effect was chloral hydrate, which began to be used in the middle of the 19th century. The drug, in addition to sleeping pills, has a calming effect. Chloral hydrate induces sleep, close to physiological, lasting 6-8 hours. However, the pronounced irritant effect on the skin and mucous membranes, as well as the development of a state of drug dependence, sharply reduces the value of chloral hydrate as a hypnotic.This drug is currently not used for this purpose.

A significant success in the search for hypnotics was the synthesis in 1902 by the German chemist E. Fischer of barbituric acid derivatives – barbital and phenobarbital, which had a pronounced hypnotic effect. This was, without a doubt, a significant achievement in the search for new drugs for insomnia. Therefore, already in 1904, E. Fischer received the Nobel Prize for this discovery. Then they began to synthesize new derivatives of not only barbituric acid, but also other chemical groups.

Unfortunately, the first success was somewhat overshadowed by the side effects caused by barbiturates. In the morning, the person did not feel cheerfulness, freshness, general (albeit insignificant) fatigue, decreased ability to work, deterioration of mood arose. Research began to study the mechanism of this action.

One of the disadvantages of the action of barbiturates on the human body was that the sleep caused by these drugs does not “fit” into the phases of normal sleep. If we add to this that drug dependence develops as a result of the intake of barbiturates, then it becomes clear why these medicines have not been practically used in the treatment of insomnia in recent years.

At the end of the 60s, a new group of hypnotics appeared – derivatives of benzodiazepines (diazepam, phenazepam, chlordiadepoxide, etc.), which have not only a hypnotic, but also a sedative (tranquilizing) effect. The hypnotic effect of benzodiazepine derivatives is more physiological and resembles natural normal sleep, so they are widely used to treat various forms of insomnia.

However, with the use of benzodiazepines, the development of undesirable effects is also possible, such as: slight daytime sleepiness, fatigue, headache, impaired coordination of movements, muscle weakness.They should not be prescribed to pregnant women due to adverse effects on the fetus (mental retardation, muscle hypotonia). Unfortunately, it turned out that drugs in this group are capable of causing even more pronounced drug dependence than barbiturates. This has significantly limited the use of benzodiazepine derivatives for insomnia.

Zolpidem hemisuccinate is a derivative of imidazopyridines. In addition to the hypnotic effect, the drug has a sedative, as well as a slightly pronounced anxiolytic, anticonvulsant and central muscle relaxant effect.Zolpidem hemisuccinate is prescribed at a dose of 10–20 mg for situational, short-term and chronic sleep disorders, including difficulty falling asleep, night and early awakenings. In a review article on the pharmacotherapy of insomnia, J.L. Goren et al (1999), note that zolpidene, by interacting with benzodiazepine receptors, can cause drug dependence.

In recent years, a new hypnotic drug, an ethanolamine derivative, DONORMIL (doxylamine succinate), has been used in medical practice.

DONORMIL is available in the form of film-coated tablets and effervescent tablets. One tablet, both effervescent and film-coated, contains 15 mg of doxylamine succinate.

DONORMIL is widely used in Western and Central Europe, the Middle East, etc., and in most countries DONORMIL is included in the group of non-prescription drugs.

Pharmacokinetic properties of DONORMIL are characterized by the fact that the active ingredient, doxylamine succinate, is well absorbed from the intestine.Its half-life from blood plasma is comparable to that of benzodiazepines. The biotransformation of doxylamine succinate is carried out in the liver only partially. The main part of the drug (about 60%) is excreted unchanged in the urine, partly in the feces.

The pharmacodynamics of DONORMIL can be distinguished: 1) features of the mechanism of action; 2) the physiology of the hypnotic effect.

1. A feature of the mechanism of the hypnotic action of DONORMIL is that the active substance of the drug – doxylamine succinate acts simultaneously on M-cholinergic (which reminds of central anticholinergics) and H 1 -histamine (which resembles an antihistamine drug – diphenhydramine (diphenylhydramine)) receptors in central nervous system (CNS).This combined effect on receptors in the central nervous system enhances the hypnotic effect, as well as the development of the sedative effect of the drug.

2. Unlike other sleeping pills, DONORMIL increases not only the duration and improves the quality of sleep, but also does not disturb the physiological phases of normal sleep and circadian rhythms. This is one of the most important features of the new sleeping pill DONORMIL.

Indications for its use are sleep disorders and insomnia of various origins in patients aged 15 years and older.

Usually the drug is prescribed in a dose of 1 / 2-1 tablet 15-30 minutes before bedtime. However, depending on the individual patient’s response, the dose of the drug can be reduced to 1/4 of a tablet or increased to 2 tablets. The effervescent tablet is dissolved in 150 ml of water, and the coated tablet is washed down with water. In this case, the patient should know that the duration of sleep will be at least 7-8 hours, if the expected sleep period is less, then after awakening for a short time, a decrease in psychoemotional activity is possible.The drug is prescribed in courses: the first course lasting 10 days. This is enough to normalize sleep. If necessary, repeat 10-day courses are carried out with a break of 10-15 days.

At the Department of Dermatology and Venereology of the National Medical University, clinical studies were carried out to study the effectiveness of DONORMIL as a hypnotic. The study compared the effect of DONORMIL and diphenhydramine in dermatological patients (eczema, pemphigus, mycosis, psoriasis) suffering from insomnia.The results of the study convincingly indicate that DONORMIL is significantly superior to diphenhydramine in terms of the effectiveness of the hypnotic effect, and at the same time it has practically no antihistamine effect.

The hypnotic effect of DONORMIL in patients with various types of insomnia was studied at the Center for Somnological Research of the Russian Federation (Moscow) and at the Department of Nervous Diseases of the Moscow Medical Academy (headed by Corresponding Member of the Russian Academy of Medical Sciences, Prof. AM Vein). Investigated the effect of the drug on the duration of sleep and its latency period.The duration of various stages of sleep was determined in accordance with international requirements according to the data of the encephalogram, electrooculogram, electromyogram, as well as on the basis of subjective and objective data. The results of the study convincingly indicate that DONORMIL has a pronounced hypnotic effect and normalizes the structure of sleep, as a rule, without causing the development of side effects. At the same time, the effective therapeutic effect of Donormil on patients with severe sleep disorders was noted.DONORMIL reduced the duration of falling asleep, the duration of sleep, and also increased the duration of the phases of slow wave sleep.

In 1996, Schadeck B. et al completed a multicenter, randomized, double-blind study involving 338 patients, which compared the severity of the hypnotic effect and the safety of doxylamine succinate and zolpidem. The study revealed a high activity of both drugs without significant differences in their safety and effectiveness.However, side effects were less common in the doxylamine succinate group. Thus, the results of the study indicate that doxylamine succinate is an effective and safe drug that does not cause addiction, which, in terms of its pharmacological properties, does not require special registration and storage conditions and is available to the widest range of people with sleep disorders.

Side effects are observed only with the use of the drug in high doses, in these cases, drowsiness in the daytime, dry mouth may appear, and even more rarely, accommodation disturbances and constipation are observed.

Contraindications to the appointment: glaucoma, age up to 15 years, hypersensitivity to the drug, lactation period.

It should be remembered that with the simultaneous use of DONORMIL with barbiturates, benzodiazepines, clonidine, opiate analgesics, neuroleptics, tranquilizers, an increase in the inhibitory effect on the central nervous system is noted.

With the simultaneous administration of DONORMIL with atropine or other blockers of M-cholinergic receptors, the risk of developing anticholinergic side effects increases: dry mouth, urinary retention is possible.Alcohol enhances the sedative effect of DONORMIL. As already noted, after taking DONORMIL, you should take 7-9 hours to sleep, if the duration of sleep is insufficient, then a weakening of attention is possible, which can complicate driving or working with various mechanisms.

Overdose is possible only when taking the drug in very high doses.

Symptoms: mydriasis, hyperemia of the skin of the face, hyperthermia, impaired coordination of movements, tremors, convulsions are possible.If untreated, severe hypotension may occur, accompanied by the development of collapse. The phase of excitement and development of seizures may be preceded by a state of depression of the central nervous system.

Treatment: symptomatic. It is necessary to rinse the stomach, prescribe sorbents, saline laxatives. According to indications, anticonvulsants are used.

Thus, DONORMIL has the following characteristic features of pharmacological action in clinical use:

1.DONORMIL causes prolonged and deep sleep, without disturbing its physiological phases (sleep structure), awakening is not accompanied by drowsiness, which contributes to active and productive activity during the day, as well as an improvement in the quality of life.

2. DONORMIL is effective in almost all forms of sleep disorders, since it eliminates various pathological processes leading to insomnia.

3. After taking DONORMIL in therapeutic (recommended) doses, patients have no aftereffect (headache, weakness, general weakness, etc.).).

4. The drug is well tolerated by patients. When using DONORMIL in therapeutic doses, side effects are extremely rare.

5. DONORMIL does not cause drug dependence and withdrawal symptoms.

Thus, an effective hypnotic drug, DONORMIL, has appeared in the arsenal of doctors, which can be widely used in clinical practice for the treatment of various forms of insomnia. An ethanolamine derivative – Donormil is one of the most effective and safe hypnotics, the use of which restores normal physiological sleep in a person suffering from insomnia.

Ivan Chekman,
Corresponding Member NAS and AMS of Ukraine, Honored Worker of Science and Technology of Ukraine, Professor, Head of the Department of Pharmacology with a course in Clinical Pharmacology of the National Medical University. A.A. Bogomolets

REFERENCES
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