Short-Term & Adverse Effects of Ambien

Ambien, the brand name for zolpidem, is a sedative-hypnotic medication commonly prescribed for the short-term treatment of insomnia.¹ While effective, Ambien does have risks, including the potential for next-day drowsiness, misuse and dependence. Ambien use can cause several side effects—some of which are relatively benign while, although rare, others can lead to serious injury or even death. Additionally, the use of Ambien with other substances, especially opioids and other central nervous system (CNS) depressants, like alcohol and benzodiazepines, can be dangerous and potentially life-threatening.¹

Continue reading to understand how Ambien works; its potential side effects and risks, including complex sleep behaviors, its addictive potential, and signs of misuse and overdose. Additionally, get a better understanding of the how to stop if you or a loved one struggle with Ambien, sedative, or other prescription drug misuse.

What is Ambien?

Zolpidem (Ambien), zaleplon (Sonata), and eszopiclone (Lunesta) are three non-benzodiazepine prescription sedatives collectively referred to as “z-drugs.” All three work as CNS depressants and all three belong to the DEA Schedule IV controlled substances list, which means there is currently a medical use in the United States, but the drug may lead to limited physiological dependence.^1-3

Ambien is intended for short-term use and the drug label cautions that treatment should be “as short as possible.” The risk of dependence of z-drugs like Ambien increases with longer-term usage (more than 10 nights).  Combining Ambien with opioids or other CNS depressants—including alcohol and benzodiazepines—and taking higher doses of the drug can result in potentially dangerous symptoms of oversedation.¹ In fact, case reports suggest that Ambien may have some misuse potential when taken at higher doses, even among individuals with no prior history of misusing drugs or alcohol. ⁴

Ambien Side Effects

The side effects of Ambien may range from mild symptoms such as drowsiness to more severe symptoms that should be discussed with your doctor, including complex sleep behaviors, suicidal thoughts, and significant next-day impairment.

Serious Side Effects and Potentially Dangerous Adverse Effects of Ambien

Ambien has many potentially serious side effects that can lead to adverse outcomes and warrant notifying a doctor immediately. These include experiencing complex sleep behaviors, significant next-day impairment, abnormal behavioral changes (e.g., depression and suicidal thoughts and actions), and overdose. A person’s risk of experiencing potentially dangerous adverse effects are greater with longer-term use, use at higher doses (particularly for women and adults over the age of 65), and with concomitant use of opioids, benzodiazepines, or other CNS depressants (including alcohol).^1,5

Complex Sleep Behaviors

While Ambien and other z-drugs were originally marketed as being safer and less addictive than other sedative-hypnotics, reports of complex sleep behaviors caused the U. S. Food and Drug Administration (FDA) to add a boxed warning to the Ambien label in 2019. It states that complex sleep behaviors—such as sleepwalking, sleep-driving, sleep-cooking, and engaging in other activities while not fully awake may occur—and carry a risk (though rare) of serious and potentially fatal injury to oneself or others. The FDA also added a contraindication, which means individuals who have experienced complex sleep behaviors in the past should not take Ambien or any of the z-drugs and should inform their prescriber. Complex sleep behaviors can occur at therapeutic doses of zolpidem with or without another CNS depressant or alcohol.^1,6

Next-Day Impairment

Even before the boxed warning, the FDA lowered the recommended dose for all zolpidem products due to next-day impairment. Additionally, the FDA suggested that individuals taking the extended-release zolpidem (Ambien CR) not drive or participate in activities that require complete alertness the day after taking the sleep medication since zolpidem levels can remain high enough to impair them—even the next day. ⁷

The risk of experiencing next-day impairment is highest for those taking controlled-release zolpidem (Ambien CR or generics), and higher for women, since zolpidem is eliminated more slowly in women than it is in men.⁸

Depression and Suicide Risk with Ambien

Research indicates that the use of Ambien and other sedative-hypnotic medications may worsen depression or suicidal thoughts and behaviors in primarily depressed individuals.¹ Thus, the drug’s FDA label cautions that individuals with depression should be prescribed the lowest number of tablets to avoid intentional overdose.¹

It’s important to note that, in general, behavioral therapy is the mainstay of treatment for insomnia, and pharmacological interventions should be considered only when necessary.⁹

Ambien Overdose

Overdose is possible if zolpidem is used alone or in conjunction with other substances and can lead to coma or even death. The likelihood of experiencing an Ambien overdose is higher when the drug is taken in higher doses or if it is taken with opioids or another CNS depressant (e.g., benzodiazepines, alcohol, other z-drugs). Symptoms of potential overdose may include:¹

• Impaired consciousness.
• Extreme sedation.
• Severe respiratory depression (i.e., slowed, shallow, or irregular breathing).

Ambien Misuse, Addiction, and Withdrawal

In 2020, approximately 803,000 (0.3%) adults aged 18 or older reported misusing zolpidem products.¹⁰

Individuals with a history of addiction or substance use disorder are at an increased risk for Ambien misuse and addiction.¹ The risk of misuse increases the longer a person takes Ambien.¹

Although it’s rare, use of Ambien can lead to physiological dependence.¹ Dependence is a physiological adaptation of the body to a substance, meaning the body becomes so used to the drug being present in the system that when an individual decreases their use significantly or quits altogether, withdrawal symptoms surface. The risk of dependence increases the longer a person takes Ambien.¹

When an individual becomes dependent on Ambien and they abruptly stop taking it or drastically reduce their dose, they may experience withdrawal symptoms. This is not common, and in clinical trials occurred in 1% (or less) of individuals who stop their use of the drug—but case studies and anecdotal evidence suggest that rate is likely higher. Withdrawal symptoms may include:^1,11

• Fatigue.
• Nausea.
• Lightheadedness.
• Vomiting.
• Trouble sleeping.
• Panic attack.
• Abdominal pain.
• Nervousness.
• Uncontrollable crying.
• Flushing.
• Stomach cramps.
• Seizures.

How to Safely Use and Safely Stop Ambien Misuse

Individuals should adhere to the dose, duration, and other instructions provided on the Ambien drug label and those given by their healthcare provider. Any abnormal behavior, specifically complex sleep behaviors, suicidal thoughts, or significant next-day impairment should be reported to your doctor as soon as possible. ¹

Additionally, individuals should avoid consuming alcohol or taking opioids and other CNS depressants (benzodiazepines, other z-drugs, or other prescription sedatives) with Ambien.

If you or a loved one struggles with Ambien misuse—or other sedative or prescription drug misuse—it might be time to seek treatment.

If you’re ready to stop, it’s a good idea to talk to your doctor, but you may also benefit from medical detox, especially if your misuse of Ambien takes place in conjunction with additional substances, such as alcohol, opioids, or other sedatives. Withdrawal symptoms resulting from one or more CNS depressant substances can be extremely unpleasant and potentially dangerous.¹²

While detoxification can stabilize a person as their body rids itself of a substance, it’s generally not sufficient to support long-term abstinence, and is considered a first step in a more comprehensive treatment plan, which benefits many people in their recovery efforts.

Addiction treatment typically includes individual and group counseling, behavioral therapies, and education to help you identify the emotions, thoughts, and behaviors that led to substance misuse and teach you strategies to aid you in identifying triggers, developing coping techniques, preventing relapse, and remaining substance free.

About The Contributor

Nitara Osbourne

Author, American Addiction Centers

Nitara Osbourne, M.Ed., is an award-winning writer and Content Specialist at American Addiction Centers.

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Last Updated on Jun 22, 2023

Ambien side effects and how to avoid them

Ambien side effects | Memory loss | Hallucinations | Ambien vs. Ambien CR side effects | How long do side effects last? | Warnings | Withdrawal | Overdose | Interactions | How to avoid side effects 

Ambien (zolpidem tartrate) is a brand-name prescription sleep-inducing drug used for the occasional treatment of insomnia. Ambien reduces the amount of time it takes to fall asleep and increases sleep duration. As with all sedative-hypnotic drugs, it is important to fully understand the drug’s potential side effects, warnings, and drug interactions before taking the medication.

RELATED: Learn more about Ambien | Get Ambien discounts

Common side effects of Ambien

The most common side effects of Ambien are:

• Headache 
• Drowsiness
• Dizziness
• Nausea
• Allergic reactions
• Muscle pain
• Back pain
• Anxiety
• Intoxication (drugged feeling)
• Sinus congestion
• Nasal congestion
• Low energy
• Memory problems
• Disorientation
• Dry mouth
• Diarrhea
• Vision problems
• Blurred vision
• Eye redness
• Attention problems
• Palpitations 
• Lightheadedness
• Constipation

Most of these side effects are short-term and will subside in a few hours to a day after taking Ambien.  

Serious side effects of Ambien

Ambien slows down the brain, so Ambien’s most serious side effects are related to its effects on the brain. These include:

• Complex sleep behaviors (sleepwalking, sleep-driving, etc)
• Next-day mental impairment
• Confusion and severe disorientation
• Hallucinations
• Depression
• Suicidality
• Severe allergic reactions such as a sudden drop in blood pressure (anaphylaxis), shortness of breath, or airway closure
• Dependency, abuse, and withdrawal

Ambien includes an FDA black-box warning for complex sleep behaviors—normal waking activities performed while asleep such as sleepwalking, sleep-driving, sleep cooking, or similar activities. Complex sleep behaviors caused by zolpidem can result in injury, death, and even homicide. Ambien will be immediately discontinued if complex sleep behaviors are experienced while taking the drug.  

Because of the risk for dependency and abuse, Ambien is classified as a controlled substance by the Drug Enforcement Agency (DEA). It is not approved for long-term use. Also, zolpidem worsens depression, so Ambien should not be taken by people with depression.

People who take prescription sleep aids may be three to five times more likely to die or contract cancer than people who don’t take sleeping pills. The reasons for this are not well-understood. However, the risk is dose-dependent, so it is lowest for people who take sleep medicine only a few times a year.

Ambien memory loss

In clinical trials, Ambien produced clinically significant memory loss in less than 1% of patients taking the recommended dose. 

When zolpidem affects memory, patients do not lose existing memories. Instead, the brain loses the ability to form new memories, a condition called anterograde amnesia. While clinically significant memory loss is very rare, nearly everyone who takes Ambien will experience some degree of memory impairment. The effects are temporary, and memory improves when the drug is discontinued.

Ambien has also been associated with an increased risk of dementia—a general deterioration in mental function—in the elderly. For this and other reasons, the recommended dose for the elderly is half the adult dose.

Ambien hallucinations

In clinical trials, less than 1% of patients reported visual or auditory hallucinations (false perceptions). Hallucinations are more likely to be experienced by people with existing neurological disorders, such as attention deficit hyperactivity disorder (ADHD), mental illness, or use of other mind-altering drugs. Hallucinations are more common among children and the elderly than adults. 

There are some cases where patients taking zolpidem have experienced delirium, that is, severe confusion, disorientation, and hallucinations. Ambien-induced delirium, however, is an extremely rare side effect and seems to be limited to the elderly.

Ambien vs. Ambien CR side effects

Ambien can be taken in immediate-release (Ambien) or extended-release format (Ambien CR). Immediate-release Ambien is prescribed to help people fall asleep at night, but Ambien CR is intended to help people fall asleep and stay asleep through the night. It combines a standard dose of immediate-release Ambien with a smaller dose of extended-release Ambien. 

Because Ambien CR is released more slowly into the body, it causes more pronounced residual effects the day after it was taken. This includes mental impairment, memory impairment, and lack of coordination. Patients taking Ambien CR should avoid next-day activities requiring mental alertness such as driving or operating machinery.

How long do Ambien side effects last?

Ambien is quickly metabolized by the body and falls to undetectable levels in the bloodstream in less than a day. Higher doses, however, may remain in the system for as long as three days. Side effects typically do not last longer than these periods. 

If Ambien is used chronically or in high doses, withdrawal symptoms may begin six to eight hours after the drug is discontinued and last as long as one to two weeks.

Ambien contraindications & warnings

Healthcare providers prescribe Ambien cautiously and will monitor patients carefully. Several red flags may prompt a healthcare provider to either avoid prescribing the drug in the first place or discontinue an existing prescription, such as complex sleep behaviors, allergic reactions, depression, underlying medical conditions, history of substance abuse, and other existing conditions. 

Complex sleep behaviors

Because Ambien may cause potentially dangerous complex sleep behaviors such as sleepwalking, sleep-driving, sleep-eating, and similar sleep disorders, Ambien is not prescribed to patients who have experienced complex sleep behaviors. Ambien will be immediately discontinued at the first instance of complex sleep behaviors. 

Allergic reactions

Ambien will also be discontinued if it causes a severe allergic reaction involving anaphylaxis—a sudden drop in blood pressure—or angioedema (skin swelling), a condition marked by symptoms such as trouble breathing and airway obstruction.

Depression

Ambien can worsen symptoms of depression, so it will be prescribed with caution to patients with depression. In addition, Ambien may interact with certain antidepressant medications (SSRIs and MAO inhibitors), so these prescriptions may need to be modified.

Underlying medical conditions

  Problems with falling asleep or staying asleep are often a symptom of an underlying psychiatric or physical illness. Ambien may not be the right therapy if the underlying condition can be treated. Ambien, then, is not prescribed until a thorough physical and psychiatric evaluation has been made.

Existing medical conditions

Ambien slows down breathing, so patients with pre-existing respiratory problems such as chronic obstructive pulmonary disease (COPD), myasthenia gravis, or sleep apnea may require special precautions.

People with liver disease, myasthenia gravis, respiratory disease, or a history of drug abuse or mental illness may also not be suitable candidates for Ambien or Ambien CR. Ambien will be prescribed with caution at a lower dose for the elderly, women, children, and debilitated patients.

Pregnancy and breastfeeding

Zolpidem will cross the placenta and enter a fetus’ bloodstream. Newborns may experience respiratory depression, sedation, poor muscle tone, and withdrawal symptoms if Ambien is taken late in pregnancy. Breastfeeding infants are also exposed to tiny amounts of Ambien in breast milk. Healthcare providers are cautious about using zolpidem in the third trimester of a pregnancy or in women who are nursing.

Ambien withdrawal

When used as directed, Ambien causes dependence and withdrawal in less than 1% of patients according to clinical and postmarketing trials. However, if Ambien is used chronically or in high doses, dependence and withdrawal are more likely.

Withdrawal symptoms can be mild or severe depending on how much Ambien is being taken and how quickly the drug is discontinued. These symptoms can start within a few hours of suddenly stopping the medication, reducing the dosage, or missing a dose. Symptoms include sleeplessness (rebound insomnia), anxiety, drug cravings, irritability, aggression, mood changes, tremors, fatigue, panic attacks, and rapid heartbeat. The most serious withdrawal symptoms are seizures.

Ambien overdose

Ambien is a relatively safe medication when taken at the recommended dosage of 5 mg to 10 mg in a single 24-hour period. Ambien overdose (70 mg in 24 hours) or combining Ambien with similar depressants can cause hazardous and potentially fatal side effects. Ambien primarily slows the brain, so an overdose can result in confusion, delirium, loss of consciousness, or coma. It also slows the heart rate and breathing, a potentially life-threatening side effect. Ambien overdose has been known to cause fatalities.

Ambien interactions

Ambien is considered a central nervous system (CNS) depressant, that is, it slows down the brain. Ambien can enhance the sedative, motor impairment, and side effects of other CNS depressants or vice versa.   For this reason, healthcare providers will try to avoid combining Ambien with other CNS depressants such as:

• Alcohol, marijuana, cannabinoids, melatonin supplements, valerian root, or kava
• Antihistamines such as promethazine, azelastine, or doxylamine  
• Barbiturates such as secobarbital, butalbital, or butabarbital
• Narcotics (opioids) such as codeine, hydrocodone, or oxycodone
• Sedatives such as Belsomra (suvorexant), zaleplon, or Dayvigo (lemborexant)
• Benzodiazepines such as alprazolam, diazepam, temazepam, or lorazepam
• Muscle relaxants such as orphenadrine, baclofen, or chlorphenesin
• Anxiety medications such as buspirone
• Nerve pain drugs such as gabapentin or pregabalin
• Nausea medications such as metoclopramide, alizapride, or droperidol
• Anticonvulsants such as carbamazepine, rufinamide, or valproic acid
• Parkinson’s disease medications such as pramipexole, ropinirole, rotigotine, or piribedil
• Some antipsychotic drugs such as levomepromazine, methotrimeprazine, haloperidol, or blonanserin
• The narcolepsy drug Xyrem (sodium oxybate)

If the use of other CNS depressants can’t be avoided, the Ambien dose may be reduced or the other prescriptions may be modified. When taking Ambien, patients should not take CNS depressants or alcohol near bedtime. Combining Ambien with over-the-counter antihistamines such as Benadryl (diphenhydramine) will also increase the risk and severity of Ambien side effects.

Ambien will enhance the side effects and toxicity of selective serotonin reuptake inhibitors (SSRIs), drugs normally prescribed to treat depression. Again, the prescribing doctor may modify therapy or reduce the Ambien dose. MAO inhibitors, another class of antidepressants that include Marplan (isocarboxazid) and Nardil (phenelzine), will decrease the effectiveness of Ambien, so the prescribing physician will need to monitor therapy.

Some drugs, particularly anticancer immunotherapy drugs, increase the body’s ability to metabolize and eliminate Ambien from the body. These drugs decrease the blood concentration and effectiveness of Ambien. Some of the most common are Taflinar (dabrafenib), Tibsovo (ivosidenib), Balversa (erdafitinib), Lorbrena (lorlatinib), Kevzara (sarilumab), Sylvant (siltuximab), Actemra (tocilizumab), Xtandi (enzalutamide), Lysodren (mitotane), and bosentan. Some corticosteroids such as hydrocortisone and budesonide also may decrease Ambien’s effectiveness. St. John’s wort, a popular herbal supplement, also decreases the concentration and effectiveness of Ambien in the body.

Other drugs and foods, however, increase the concentration of Ambien in the blood and so increase the risk of Ambien side effects. These include:

• Grapefruit, peppermint oil, and goldenseal
• Certain types of antibiotics such as ciprofloxacin, clarithromycin, and erythromycin
• Antifungal (azole) drugs such as itraconazole or ketoconazole
• Certain types of antiviral medications such as ritonavir, atazanavir, darunavir, Invirase (saquinavir), and Crixivan (indinavir)
• Blood pressure medications such as verapamil
• Benzodiazepine sedatives such as diazepam and midazolam
• Corticosteroids such as dexamethasone or fluticasone

These drugs, foods, or supplements don’t need to be discontinued or modified. However, it’s important for people taking these drugs along with Ambien to be careful about engaging in potentially risky activities that require mental alertness such as driving, operating machinery, or participating in dangerous activities.

How to avoid Ambien side effects

Most drugs cause side effects, and Ambien is no different. Because Ambien slows down the brain, most of the side effects are related to its sedative properties: sleepiness, dizziness, motor impairment, slow reflexes, and decreased alertness. You can reduce the risk of side effects by following a few simple rules of thumb:

1.  Take Ambien as directed

You will be prescribed a nighttime dose of 5 mg, 10 mg, or if taking Ambien CR, 12.5 mg. Do not exceed this dosage or take more than two pills in a 24-hour period even if the first dose doesn’t work. The dose will be reduced for women, the elderly, or people taking other types of drugs, so don’t try to increase the dose to the “normal” dose. 

2.

  Tell your doctor about all your medical conditions and medications

Because of the risk of side effects, you should tell your doctor about:

• Any physical conditions you may have, particularly liver problems or respiratory disease
• Your history with psychiatric conditions
• Any alcohol use, recreational drug use, or history of substance abuse
• Any mental impairment you may be experiencing
• All medications you are currently taking
• All over-the-counter medications and supplements you typically take
• Potentially dangerous daytime activities that you engage in, such as operating heavy machinery or driving to work

Always talk to your doctor about any side effects experienced when taking a prescription medication.

3.  Practice good sleep hygiene

You should use Ambien as infrequently as possible. The safest use of Ambien is to develop good sleep hygiene and take the medication only when all else fails.

• Avoid stimulating activities such as television watching or video games before bedtime.
• Develop nighttime relaxation habits such as taking a hot bath, meditating, or doing yoga for a half-hour or an hour before bedtime.
• Go to bed at the same time each night. Some people set an alarm for bedtime.
• Turn off the light and eliminate all distractions when going to bed.
• Exercise every day.
• Avoid foods such as caffeine, alcohol, and sugar that interfere with the ability to fall asleep.

4.  Avoid certain foods, supplements, and drugs

Some foods, herbs, and drugs enhance the adverse effects of Ambien. Your healthcare provider can help you navigate the drug interactions between Ambien and any prescription drugs you’re taking. To take Ambien safely, you should avoid alcohol, marijuana, grapefruit, melatonin supplements, valerian root, cannabidiol, chamomile, goldenseal, lemon balm, passionflower, calendula, gotu kola, and over-the-counter antihistamines. All of these substances increase the sedative effects of Ambien and increase the risk of side effects, particularly next-day mental impairment. Before you start taking any dietary supplements or herbal medicines, talk to your prescribing physician first.

Resources:

• Ambien, Sanofi
• Ambien prescribing information, Sanofi
• Ambien CR prescribing information, Sanofi
• What is Ambien: Uses, warnings, and interactions, SingleCare
• Zolpidem, Epocrates
• Zolpidem, StatPearls
• Acute effects of zolpidem extended-release on cognitive performance and sleep in healthy males after repeated nightly use, Experimental and Clinical Psychopharmacology. 
• Drug interactions with CYP3A4: an update, Pharmacy Times
• Multimodal hallucination (audio-visual, kinaesthetic, and scenic) associated with the use of zolpidem, Clinical Psychopharmacology and Neuroscience

Zolpidem: Pediatric Medication | Memorial Sloan Kettering Cancer Center

Pediatric Medicine

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Provided by Lexicomp ^® , this document contains all the information you need to know about this medicine, including indications, directions for use, side effects, and when your healthcare provider should be contacted.

Trade names: USA

Ambien; Ambien CR; Edluar; Intermezzo [DSC]; Zolpimist [DSC]

Trade names: Canada

APO-Zolpidem ODT; MINT-Zolpidem ODT; PMS-Zolpidem ODT; Sublinox

Warning

• Some people who take this drug do activities such as sleep walking, sleep driving, cook and eat food, have sex, or engage in other activities without fully waking up. In rare cases, this has resulted in serious injury or death. In most cases, these individuals had no memory of having performed these acts. If the above effect occurs, stop giving this drug to your child and tell your doctor immediately.

What is this drug used for?

Tablets:

• It is used to treat sleep disorders.
• This drug is not approved for use in children. Children may be at increased risk of side effects such as dizziness and hallucinations. However, your child’s doctor may decide that the benefits of this drug outweigh the risks. Talk to your doctor if you have any questions about the use of this drug in your child.

All other dosage forms:

• This drug is not approved for use in children. Consult your doctor.
• If your child has received this drug, ask your doctor about the benefits and risks. Talk to your doctor if you have any questions or concerns about the use of this drug in a child.

What do I need to tell the doctor BEFORE my child takes this drug?

• If your child has an allergy to this drug, any of its ingredients, other drugs, foods, or substances. Tell the doctor about the allergy and how it manifested itself in the child.
• If your child has liver disease.
• If the child is taking drugs or natural products to achieve a sedative effect. There are many drugs that are used in connection with sleep disorders. If in doubt, ask your child’s doctor or pharmacist.
• If your child has taken this or similar drugs in the past and performed any task or activity without ever waking up.
• If your child is taking any of these drugs: rifampin or St. John’s wort.

This list of drugs and conditions that may interact with this drug is not exhaustive.

Talk to your doctor or pharmacist about all medicines your child is taking (prescription and over-the-counter, natural, and vitamins) and any health problems. You need to make sure that this drug is safe to use for your child’s illnesses and in combination with other drugs he or she is already taking. Do not start, stop taking, or change the dosage of any drug your child is taking without the doctor’s approval.

What do I need to know or do while my child is taking this drug?

• Tell all health care providers who care for your child that your child is taking this drug. These are your child’s doctors, nurses, pharmacists and dentists.
• Keep your child away from tasks or activities that require attention until you see how this drug works for your child. This includes cycling, playing sports, or using items such as scissors, lawn mowers, electric scooters, toy cars, or motorized vehicles. Your child may feel sleepy the day after taking this drug. Make sure your child avoids these activities or activities until he is fully awake.
• Do not give this drug to your child for longer than the length of time prescribed by the doctor.
• If a child takes sleeping pills every night for more than a few weeks, their effectiveness may decrease. The so-called tolerance to the drug develops. Give sleeping pills to your child only for a short period of time. If your child has a sleep disorder, see a doctor.
• Long-term or regular use of this drug may lead to dependence. Sudden discontinuation of this drug may lead to so-called “withdrawal” symptoms. Check with your child’s doctor before reducing the dose or stopping this drug. You must follow the doctor’s instructions. Tell your doctor if your child has any side effects.
• Make sure that the child does not doze off.
• To reduce the risk of dizziness or fainting, have your child get up slowly from a sitting or lying position. Make sure your child goes up and down the stairs carefully.
• Alcohol can interact with this drug. Make sure your child does not drink alcohol.
• Check with your child’s doctor before using marijuana, other forms of cannabis, or prescription or over-the-counter drugs that may slow your child’s progress.
• If your child has phenylketonuria, talk to your doctor. Some foods contain phenylalanine.
• This drug may cause drowsiness or impair alertness. This can lead to falls and injuries that can be very serious. Very severe injuries were noted, such as a fracture of the femoral neck and cerebral hemorrhage. Consult your doctor.
• If you have a daughter, use this drug with caution. She may have more side effects.

If your daughter is pregnant or breastfeeding:

• Consult physician if your daughter is pregnant, pregnant, or breastfeeding. The benefits and risks for your daughter and her baby will need to be discussed.
• Taking this drug during the third trimester of pregnancy may cause some health problems in the newborn. Consult your doctor.

What side effects should I report to my child’s doctor right away?

WARNING/CAUTION: Although rare, some people may have very serious and sometimes deadly side effects of this drug. Call your child’s doctor right away or get medical help if your child has any of the following signs or symptoms that could be associated with a very bad side effect:

• Signs of an allergic reaction, such as rash, hives, itching, red and swollen skin with blisters or peeling, possibly accompanied by fever, wheezing or wheezing, tightness in the chest or throat, difficulty breathing, swallowing or speaking, unusual hoarseness, swelling in the mouth, face, lips, tongue or throat.
• The onset or worsening of behavioral or emotional disorders, such as depression or suicidal thoughts.
• Hallucinations (a person sees or hears something that is not in reality).
• Confusion of consciousness.
• Lack of clarity of thought.
• Labored, slow or shallow breathing.
• Balance change.
• Vision change.
• Impairment or loss of memory.
• A very bad reaction called angioedema has happened with this drug. Sometimes this reaction can be life-threatening. Symptoms may include swelling of the hands, face, lips, eyelids, tongue, or throat, difficulty breathing or swallowing, or an uncharacteristic hoarse voice. If your child has any of these symptoms, contact your doctor immediately.

What are some other side effects of this drug?

Any drug can cause side effects. However, for many people, side effects are either minor or non-existent. Contact your child’s doctor or seek medical attention if any of these or other side effects bother your child or if they persist:

• Feeling dizzy, tired or weak.
• Sleepiness the next day.
• Headache.
• Nausea.
• Diarrhea.

This list of possible side effects is not exhaustive. If you have any questions about side effects, ask your child’s doctor. Talk to your child’s doctor about side effects.

You can report side effects to the National Health Board.

What is the best way to give this drug?

Give this drug to your child as directed by your doctor. Read all the information provided to you. Strictly follow all instructions.

• If your child still has sleep problems after 7-10 days, contact your child’s doctor.
• Let’s go before bed.
• Give this drug right before your child goes to bed.
• Give this drug only once in one night.
• Give this drug on an empty stomach.
• Do not give the drug with food or immediately after a meal.
• Do not give this drug to your child until he has had at least 7 to 8 hours of sleep at night and is ready to be active again.

What if my child misses a dose of medication?

• If the child takes the drug regularly, give him the missed dose as soon as you remember about it.
• If your child is unable to get adequate sleep (for at least 7 hours) after taking the missed dose, skip the missed dose and then return to your child’s regular schedule for taking the drug.
• Do not give a double dose at the same time or additional doses.
• Do not give more than 1 dose of this drug in one day.
• In most cases, this drug is used as needed. Do not give your child the drug more often than prescribed by the doctor.

How do I store and/or discard this drug?

• Store at room temperature in a dry place. Do not store in the bathroom.
• Keep this medicine in a protected place out of sight and reach of children and out of the reach of other people. A box or room that is locked with a key can act as a secure storage place for the drug. Keep all medicines out of the reach of pets.
• Dispose of unused or expired drugs. Do not empty into a toilet or sewer unless instructed to do so. If you have any questions about disposing of medicines, ask your pharmacist. Drug disposal programs may be in place in your area.

General information about medicines

• If your child’s symptoms or health problems do not improve, or worsen, contact your child’s doctor.
• Do not share your child’s medicine with others and do not give anyone else’s medicine to your child.
• Some medicines may come with other patient information leaflets. If you have questions about this drug, talk with your child’s doctor, nurse, pharmacist, or other health care professional.
• If you think you have overdosed, call a poison control center or get medical help right away. Be prepared to tell or show what drug you took, how much, and when it happened.

Consumer Use of Information and Limitation of Liability

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Last revision date

2022-03-22

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Date last updated

Monday, December 12, 2022

Zopiclone, zaleplon and zolpidem, drugs to avoid in patients with dementia

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Relevance

Sleep disturbances are common in patients with dementia. It is not uncommon for patients to receive so-called Z-drugs (zopiclone, zaleplon, and zolpidem). Previous studies have shown an increased risk of side effects with Z-drugs, including falls and fractures in older patients. However, it has not been previously studied how high the risk of falls and fractures is in patients with dementia.

Study design

The English researchers used data from 27,090 dementia patients.

The study authors compared the side effects of 3532 patients who were first prescribed Z drugs with 1833 patients with sleep disorders who were prescribed non-sedative drugs, with 10 214 patients who were prescribed non-sedative drugs in a general practitioner setting, and with 5172 patients who were first prescribed benzodiazepines.

High dose Z-drugs and benzodiazepines were equivalent to ≥ 7.5 mg zopiclone or > 5 mg diazepam.

Primary endpoints for were fracture, falls, mortality, acute bacterial infections, ischemic stroke/transient ischemic attack, and venous thromboembolism over 2 years of follow-up.

Results

• The mean age of the patients was 83 years. 62% of patients were women. It was noted that among 3532 patients who started taking Z-drugs, 17% started taking a high dose.
• Patients treated with high-dose Z-drugs, compared with patients with sleep disorders who did not receive drugs, had a 1.67-fold increased risk of fracture, 1.96-fold femoral fracture, 1.33-fold increased risk of falls, and ischemic stroke by 1.88 times.
• Similar results were observed when compared with non-sedative drugs prescribed by primary care physicians.
• Minimal risks have been observed with doses ≤ 3.75 mg of zopiclone.
• There was no significant increase in risk with Z-drugs compared with non-sedative drugs in terms of mortality, infections, and venous thromboembolism.