Dayvigo is a brand-name oral tablet that’s prescribed to treat insomnia in adults. Dayvigo contains the active ingredient lemborexant and belongs to the dual orexin receptor antagonists (DORAs) drug class.

Drug details

You’ll find key information about Dayvigo below.

  • Drug form: oral tablet
  • Generic available? no
  • Prescription required? yes
  • Controlled substance? yes*
  • Year of FDA approval: 2019

* Dayvigo is a controlled substance. It’s classified as a Schedule IV prescription drug. A controlled substance is a drug the government regulates because it can lead to drug dependence or misuse. (With dependence, your body needs the drug to function as usual. And misuse refers to taking a drug in a way other than how a doctor prescribes it.) To learn more, see “Is Dayvigo addictive?” in the “Common questions about Dayvigo” section below.

Dayvigo is available only as a brand-name medication. It’s not currently available in a generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

Dayvigo contains the active drug lemborexant.

Dayvigo can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Dayvigo. These lists do not include all possible side effects.

For more information about the possible side effects of Dayvigo, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Dayvigo, you can do so through MedWatch.

Mild side effects

Mild side effects* of Dayvigo can include:

  • drowsiness that continues into the next day†
  • nightmares or unusual dreams
  • headache

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Dayvigo. To learn about other mild side effects, talk with your doctor or pharmacist, or view Dayvigo’s prescribing information.
† For more information about this side effect, see “Side effect details” below.

Serious side effects

Serious side effects from Dayvigo aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

  • Heart palpitations. Symptoms can include:
    • sensation of heart fluttering
    • fast heartbeat
    • feeling in your chest or neck that your heart is pounding
  • Hallucinations that occur just as you’re falling asleep or waking up. Symptoms can include:
    • seeing, hearing, or sensing something that isn’t there
    • a feeling that you’re falling or floating when you’re not
  • Temporary muscle weakness that isn’t triggered by strong emotions or laughter. Symptoms can include:
    • sudden leg or muscle weakness that can last from seconds to a few minutes
    • episodes that can occur at night or during the day
  • Suicidal thoughts or behaviors. Symptoms can include:
    • behavior or mood changes
    • new or worsened depression symptoms, such as prolonged feelings of sadness and loss of interest in activities you once enjoyed
  • Sleep paralysis.*
  • Excessive sleepiness.*
  • Unusual sleep behaviors, such as sleepwalking.*
  • Allergic reaction.*

* For more information about this side effect, see “Side effect details” below.

Suicide prevention

If you know someone at immediate risk of self-harm, suicide, or hurting another person:

  • Ask the tough question: “Are you considering suicide?”
  • Listen to the person without judgment.
  • Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis counselor.
  • Stay with the person until professional help arrives.
  • Try to remove any weapons, medications, or other potentially harmful objects.

If you or someone you know is having thoughts of suicide, a prevention hotline can help. The 988 Suicide and Crisis Lifeline is available 24 hours a day at 988. During a crisis, people who are hard of hearing can use their preferred relay service or dial 711 then 988.

Find more links and local resources.

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Side effect details

Here are some details about certain side effects this drug may cause. For additional information about side effects, refer to this article.

Sleep paralysis

Dayvigo may cause sleep paralysis in some people. In clinical studies, this was a less common side effect of the drug.

With sleep paralysis, you can’t move or talk for a time just after falling asleep or upon waking up in the morning. Episodes of sleep paralysis can last a few seconds to a few minutes.

Sleep paralysis occurs when part of your brain is fully awake, but a different part that regulates movement is still in sleep mode. This is called rapid eye movement (REM) sleep, during which certain muscles are mostly paralyzed (unable to move). In this stage of sleep, your body limits you from physically moving or flailing around as you dream to help prevent injury.

Knowing that sleep paralysis can occur with Dayvigo may help you stay calm if this side effect happens to you. Sleep paralysis lasts a few seconds to a few minutes and shouldn’t cause long-term or physical harm.

Experiencing sleep paralysis can be frightening. It’s possible to develop intense fear or anxiety during or after an episode of sleep paralysis. Some people have disturbing hallucinations (seeing or hearing things that aren’t there) during an episode of sleep paralysis.

If you develop bothersome sleep paralysis or hallucinations while taking Dayvigo, talk with your doctor. They may recommend changes to your treatment plan.

Excessive sleepiness

Taking Dayvigo may cause people to feel more sleepy and less alert than usual the next day. This can affect their ability to drive or perform other activities that require full alertness.

In clinical studies of Dayvigo, the most common side effect was somnolence (next-day sleepiness). Sluggishness and fatigue (low energy) were also reported.

Dayvigo slows down the activity of your central nervous system (your brain and spinal cord). So the drug may reduce your ability to think and react quickly. Even if you don’t feel sleepy the next day, it may still be dangerous to drive or operate heavy machinery.

10-mg strength and driving

Dayvigo oral tablets come in two strengths: 5 milligrams (mg) and 10 mg. In the studies, some people who took a 10-mg dose of the drug had difficulty driving safely the next day. If you’re prescribed a 10-mg dose of Dayvigo, your doctor may warn you not to drive at all the next day.

Steps you can take

To help prevent or minimize excessive sleepiness with Dayvigo, it’s important to take Dayvigo only right before you get into bed. You should also take the medication only if you’ll have at least 7 hours to devote to sleep before you need to wake up.

While taking Dayvigo, it’s also helpful to avoid taking other medications or substances that cause sleepiness. For some examples, see “Other central nervous system depressants” in the “Dayvigo interactions” section below.

Keep in mind that insomnia, which Dayvigo treats, may make you feel excessively sleepy the next day. Insomnia can also make next-day driving dangerous. If you’re concerned about excessive sleepiness due to Dayvigo or insomnia, talk with your doctor. They may be able to suggest ways to ease it.

Unusual sleep behaviors

Taking Dayvigo may cause some people to have unusual behaviors in sleep. This refers to getting out of bed and performing activities that you may not remember the next day.

Although rare, some reported activities included:

  • sleepwalking
  • sleep talking
  • driving a vehicle
  • preparing and eating food
  • making phone calls and talking on the phone
  • having sex

Many of these activities could result in serious injury to yourself or others, and in some cases, could be life threatening. To other people, it may look like you’re awake while you’re engaging in these activities, but your brain isn’t fully alert. The next day, you may not remember that you performed the activities. Or you may think that you dreamed that you did them.

The behaviors mentioned above can occur after your first dose or at any time during treatment with Dayvigo. In clinical studies, these behaviors happened to two people who received the 10-mg strength of Dayvigo.

Similar side effects have been reported with other insomnia drugs, such as zolpidem (Ambien and Ambien CR) and suvorexant (Belsomra).

If you or other people in your household notice that you have unusual sleep behaviors while taking Dayvigo, talk with your doctor right away. Your doctor will typically have you stop taking the medication. They may also recommend other treatment options for your insomnia.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Dayvigo. Allergic reaction wasn’t reported during clinical studies, but as with most drugs, it is possible.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • difficulty breathing

Call your doctor right away if you have an allergic reaction to Dayvigo, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Here are answers to some frequently asked questions about Dayvigo.

Can Dayvigo make you feel ‘high’?

No, it should not. No side effects of euphoria (feeling “high”) were reported during clinical studies of Dayvigo.

If you feel high or have other changes in your mood or behavior while taking Dayvigo, talk with your doctor right away. They’ll typically have you stop taking the drug and recommend other treatment options for your condition.

Is zopiclone an alternative to Dayvigo?

Not in the United States. Zopiclone is a sedative (a drug that makes you sleepy), but it’s banned in the U.S. The Food and Drug Administration (FDA) determined that zopiclone showed limited effectiveness. The FDA also determined that the drug had high rates of side effects. These side effects included greatly reducing how well a person can move, think, react, and drive.

Eszopiclone (Lunesta) is a similar drug to zopiclone. Eszopiclone is FDA-approved in the U.S. to treat insomnia in adults and may be taken as an alternative to Dayvigo.

If you have questions about other insomnia treatments and how they compare with Dayvigo, talk with your doctor.

Is Dayvigo addictive?

It’s possible that Dayvigo may be psychologically addictive (emotional or mental addiction) for some people. This may also be referred to as “psychologically dependent,” meaning being mentally and emotionally dependent on the drug.

In clinical studies, there were no reports of physical drug dependence or withdrawal in people taking Dayvigo. (With physical dependence, your body needs the drug to function as usual.)

It’s important to note that Dayvigo is classified as a Schedule IV controlled substance because of possible misuse. (A controlled substance is a drug the government regulates because it can lead to drug dependence or misuse. And misuse refers to taking a drug in a way other than how a doctor prescribes it.)

Most controlled substances have a potential risk of drug misuse or addiction, especially in people who had or have a substance use disorder.

If you had or have a substance use disorder or have other concerns about taking Dayvigo, talk with your doctor.

As with all medications, the cost of Dayvigo can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Dayvigo. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor or your insurance company.

Before approving coverage for Dayvigo, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide whether the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Dayvigo, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Dayvigo, or if you need help understanding your insurance coverage, help is available.

Eisai, the manufacturer of Dayvigo, offers a savings card as well as a patient assistance program. For more information and to find out if you’re eligible for support, call 866-4DAYVIGO or visit the program website.

Mail-order pharmacies

Dayvigo may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Dayvigo, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor and your insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Dayvigo is not available in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

If your doctor has prescribed Dayvigo and you’re interested in taking a different treatment option that has a generic form, talk with your doctor.

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The Food and Drug Administration (FDA) approves prescription drugs such as Dayvigo to treat certain conditions. Dayvigo is FDA-approved to treat insomnia in adults.

Insomnia is a common sleep disorder. It can be short term or long term.

With insomnia, it may take you a long time to fall asleep. You may also wake up during the night and can’t fall back to sleep. Or you may experience both.

Insomnia can be caused or worsened by other medical conditions, including mental health disorders such as anxiety and depression. Some medications can also cause insomnia as a side effect.

In these cases, Dayvigo may not work as well as usual. If you don’t notice improvement in your sleep after taking Dayvigo for 7 to 10 nights, talk with your doctor. They may give you a checkup or order blood tests to find possible causes of your insomnia.

To learn about insomnia, healthy sleep habits, and more, you can refer to our sleep hub.

Effectiveness for insomnia

Clinical studies have shown Dayvigo to be an effective treatment for insomnia.

For information on how Dayvigo performed in clinical studies, visit the manufacturer’s website or read the drug’s prescribing information.

Dayvigo and children

Dayvigo is FDA-approved to treat insomnia in adults. This drug is not approved for children, and it hasn’t been studied in people younger than age 18 years.

If you’d like to learn about insomnia treatments for your child’s condition, talk with their doctor.

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

  • the severity of the condition you’re taking Dayvigo to treat
  • your age
  • the strength of Dayvigo you take
  • other medical conditions you may have

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

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

To learn more about Dayvigo’s dosages, see this in-depth article.

Drug forms and strengths: 5 mg tablet, 10 mg tablet

Dayvigo comes as an oral tablet. It’s available in two strengths: 5 milligrams (mg) and 10 mg.

Dosage for insomnia

The recommended dose of Dayvigo is 5 mg. You should take your dose right before you go to bed. And you should take Dayvigo only if you have at least 7 hours before you plan to wake up.

If taking 5 mg of Dayvigo right before bedtime doesn’t help your insomnia, your doctor may increase your dose if they feel it’s safe to do so.

The maximum dose of Dayvigo is 10 mg. Whether your prescribed dose is 5 mg or 10 mg, you should not take more than one dose of Dayvigo per night. You also should not increase your dosage unless you’ve talked with your doctor first.

For some people, a lower maximum Dayvigo dosage of 5 mg per night may be recommended. This includes people who may be at a higher risk of side effects* than usual, such as:

  • people with liver problems
  • older adults (ages 65 years and older)
  • people taking certain medications†

* To learn more about side effects, see the “Dayvigo side effects” section above.
For more information, see the “Dayvigo interactions” section below.

What if I miss a dose?

If you miss a dose of Dayvigo, you should take a dose only if you have at least 7 hours before you plan to wake up.

Taking your dose when you have less than 7 hours before you wake up increases your risk of next-day excessive sleepiness. This can interfere with your ability to work or perform tasks and can be dangerous if you’re driving.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too. You can set the reminder to go off when you usually get ready for bed.

Will I need to take this drug long term?

It depends. Dayvigo may be taken as a short- or long-term treatment. In clinical studies of Dayvigo, the drug was taken for up to 6 months.

If your insomnia doesn’t ease within 7 to 10 nights of taking Dayvigo, talk with your doctor. They may check you for other medical conditions that may cause or worsen insomnia. If they find that you have a condition that can cause insomnia, they’ll likely recommend treatment for it.

If you and your doctor determine that Dayvigo is safe and effective for you, they may suggest that you continue taking it long term.

The manufacturer of Dayvigo recommends against drinking alcohol while taking the drug.

Drinking alcohol while taking Dayvigo can increase your risk of side effects, such as:

If you drink alcohol, talk with your doctor before you begin taking Dayvigo. They can offer more information on the risks of consuming alcohol while taking this drug.

Dayvigo can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Dayvigo and other medications

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

Before taking Dayvigo, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

Dayvigo and medications

Taking Dayvigo with certain medications may increase the risk of side effects or make them more severe. Medications that can interact with Dayvigo include:

Taking Dayvigo with certain medications may cause Dayvigo not to work as well as usual. Some examples include:

Dayvigo can reduce how well some other medications work. Some examples include:

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

* For more information, see “Side effect details” in the “Dayvigo side effects” section above.

Dayvigo and herbs or supplements

You should not take St. John’s wort while taking Dayvigo. Taking this supplement can reduce the drug’s effectiveness.

Other herbs or supplements may interact with Dayvigo. Make sure to check with your doctor or pharmacist before taking any herbs or supplements while taking Dayvigo.

Dayvigo and foods

It’s recommended that you do not take Dayvigo with food. Taking the drug with food or right after eating can slow the effects of the medication. This means it could take longer for you to fall asleep.

Other drugs are available that can treat insomnia (difficulty sleeping). Some may be a better fit for you than others. If you’re interested in finding an alternative to Dayvigo, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat insomnia. Off-label drug use is when a drug approved by the Food and Drug Administration (FDA) is used for a purpose other than what it’s approved for.

Alternatives for insomnia

Examples of other drugs that may be used to treat insomnia include:

You should take Dayvigo according to the instructions your doctor or other healthcare professional gives you.

Dayvigo comes as an oral tablet.

When to take

You should take Dayvigo right before you go to bed. Be sure to take your dose at least 7 hours before you plan on waking up.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can work, too. You can set the reminder to go off when you usually get ready for bed.

Taking Dayvigo with food

It’s recommended that you do not take Dayvigo with food. Taking the drug with food or right after eating can slow the effects of the medication. This means it could take longer for you to fall asleep.

Can Dayvigo be crushed, split, or chewed?

No, you should swallow Dayvigo tablets whole. If you have difficulty swallowing Dayvigo, talk with your doctor or pharmacist.

Dayvigo is approved by the Food and Drug Administration (FDA) to treat insomnia (difficulty sleeping) in adults.

Dayvigo works by blocking the action of a brain chemical called orexin. This chemical is thought to play a role in signaling your brain to wake up.

Dayvigo helps prevent orexin from attaching to two specific receptors (binding sites) in your brain. When orexin’s action is blocked, your brain doesn’t receive signals to wake up, which helps you sleep.

If you have questions about how Dayvigo works, talk with your doctor or pharmacist.

How long does it take to work?

Dayvigo starts working as soon as you take a dose. This is why you should take your dose right before you go to bed.

If you don’t notice your insomnia easing after taking Dayvigo for 7 to 10 nights, talk with your doctor. They may have you stop taking Dayvigo. They’ll typically give you a checkup or order blood tests to find possible causes of your insomnia.

It’s not known if it’s safe to take Dayvigo while pregnant. There haven’t been enough studies in humans to know if Dayvigo is safe to take during pregnancy.

If you become pregnant while taking Dayvigo, tell your doctor right away. They’ll guide you on the safest treatment options during this time.

If you’re pregnant or planning to become pregnant, talk with your doctor before taking Dayvigo. They can advise you on whether the drug is right for you.

A pregnancy registry is available for people who take Dayvigo while pregnant. This registry collects information on the safety of taking Dayvigo during pregnancy. If you’d like more information about the registry, talk with your doctor, call 866-961-2388, or visit the registry website.

It’s not known if Dayvigo is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Dayvigo.

For more information about taking Dayvigo during pregnancy, see the “Dayvigo and pregnancy” section above.

It’s not known whether it’s safe to take Dayvigo while breastfeeding. Studies have shown that Dayvigo passes into breast milk. However, there haven’t been enough studies to know what effects the drug may have on a child who is breastfed.

If you’re breastfeeding or thinking about it, talk with your doctor before you start taking Dayvigo. They can advise you on other treatment options for insomnia and healthy ways to feed your child.

This drug comes with several precautions.

Before taking Dayvigo, talk with your doctor about your health history. Dayvigo may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Being an older adult. If you’re an older adult (ages 65 years or older), taking Dayvigo may increase your risk of certain side effects. This includes drowsiness, which can lead to falls. Because of the risk, your doctor may have you take a lower dose than usual and monitor you more often for side effects. They may also recommend that you avoid driving the day after you take a dose of Dayvigo.
  • Suicidal thoughts and mental health conditions. Taking Dayvigo may cause suicidal thoughts. It can also make depression or other mental health conditions more severe. This is why it’s important to tell your doctor if you have any of these thoughts or conditions. They may monitor you closely for mood or behavior changes while taking Dayvigo. Or your doctor may recommend other treatment options.
  • Alcohol or substance misuse. Dayvigo is a controlled substance and could be misused or cause psychological dependence. Because of these risks, Dayvigo isn’t recommended for people who have or had problems with alcohol or substance use. Instead, talk with your doctor about other insomnia treatment options.
  • Daytime sleepiness. If you have a condition that causes you to feel sleepy throughout the day, such as narcolepsy, Dayvigo isn’t recommended for you. This is because the drug can make you feel sleepy the day after taking it. If you already have daytime sleepiness, talk with your doctor about other treatment options.
  • Liver problems. Having certain liver problems may cause your body to not get rid of Dayvigo effectively. This could cause the drug to build up in your system and cause side effects. If you have liver problems that aren’t severe, your doctor may prescribe a lower dose of Dayvigo than usual. But if you have severe liver problems, the drug manufacturer recommends that you do not take Dayvigo. Your doctor may be able to suggest a different treatment.
  • Breathing or lung problems. It isn’t known how Dayvigo may affect you long term if you have a lung or breathing problem. These problems can include obstructive sleep apnea and chronic obstructive pulmonary disease (COPD). To discuss these risks and decide whether Dayvigo is right for you, talk with your doctor.
  • Allergic reaction. If you’ve had an allergic reaction to Dayvigo or any of its ingredients, you shouldn’t take Dayvigo. Ask your doctor what other medications are better options for you.
  • Pregnancy. It’s not known if it’s safe to take Dayvigo during pregnancy. For more information, see the “Dayvigo and pregnancy” section above.
  • Breastfeeding. It’s not known if it’s safe to take Dayvigo while breastfeeding. For more information, see the “Dayvigo and breastfeeding” section above.

Note: For more information about the potential negative effects of Dayvigo, see the “Dayvigo side effects” section above.

Do not take more Dayvigo than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Dayvigo

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. But if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Dayvigo from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, ask your pharmacist how to correctly dispose of it.

Storage

How long a medication remains good to take can depend on many factors, including how and where you store the medication.

You should store Dayvigo tablets at a room temperature of 68°F to 77°F (20°C to 25°C), in a tightly sealed container away from light. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Dayvigo and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today 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 another 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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