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Unisom Sleep Tabs Side Effects: Everything You Need to Know

Exploring the uses, side effects, interactions, and dosage of Unisom (Doxylamine) Oral medication. Get comprehensive information to make informed decisions about your health.

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Understanding Unisom (Doxylamine) Oral Medication

Unisom, also known by its generic name doxylamine, is an antihistamine medication primarily used to treat symptoms associated with allergies, including itchy and watery eyes, sneezing, runny nose, and skin irritation. Additionally, this medication can be utilized by adults and children 12 years of age and older who occasionally struggle with insomnia, as it can induce drowsiness and promote sleep.

How Does Unisom Work?

Unisom (doxylamine) belongs to a class of medications called antihistamines. Antihistamines work by blocking the action of histamine, a natural substance in the body that triggers allergy symptoms. By blocking histamine, Unisom can effectively alleviate the uncomfortable symptoms of allergies. Additionally, the drowsiness-inducing properties of Unisom can help individuals who occasionally have trouble sleeping (insomnia) to fall asleep more easily.

Dosage and Usage of Unisom

The typical dosage of Unisom for adults and children 12 years of age and older to aid with sleep is 25 mg to 50 mg taken orally at bedtime. It’s important to note that the appropriate dosage may vary based on factors such as individual body weight, other medical conditions, and concurrent medications. If your doctor has prescribed a different dosage, it is crucial to follow their instructions and not change the way you are taking the medication without consulting them.

Potential Side Effects of Unisom

Like any medication, Unisom (doxylamine) may cause side effects, some of which are more common than others. The most commonly reported side effects include chest congestion, constipation, dizziness, and drowsiness. If you experience any of these side effects and they are severe or bothersome, it is recommended to contact your doctor or pharmacist for guidance on managing them.

Contraindications and Precautions

Unisom should not be taken by individuals with certain medical conditions, such as an enlarged prostate, obstructed bladder, asthma or chronic lung disease, certain stomach conditions, narrow-angle glaucoma, or who have taken specific antidepressant medications (MAO inhibitors) within the past two weeks. It is crucial to inform your healthcare provider about your medical history and any other medications you are currently taking to ensure the safe use of Unisom.

Storage and Disposal of Unisom

Unisom should be stored at room temperature and kept out of the reach of children. It is important to properly dispose of any unused or expired medications, as they should not be flushed down the sink or toilet or placed in household garbage. Consult your pharmacist for the appropriate disposal methods in your area.

Frequently Asked Questions

Can Unisom cause drowsiness or impair daily activities?

Yes, Unisom can cause drowsiness, which is part of its intended effect for treating insomnia. Some individuals may find that the 50 mg dose causes excessive drowsiness that interferes with their daily activities, in which case a 25 mg dose may be more suitable.

How long do the effects of Unisom last?

The effects of Unisom can last for up to 6 hours, which is why it is typically taken at bedtime to help with sleep.

Is it safe to take Unisom for long-term use?

Unisom should not be used for more than a few nights in a row to treat insomnia. If chronic (long-term) insomnia persists for more than a few nights, it is recommended to consult your doctor about alternative treatment options that are more suitable for long-term use.

Can Unisom interact with other medications?

Yes, Unisom can interact with certain medications, including antidepressants known as MAO inhibitors. It is essential to inform your healthcare provider about all the medications you are currently taking to avoid potentially harmful interactions.

Is Unisom safe for children?

Unisom is approved for use in children 12 years of age and older to help with occasional sleep difficulties. However, it is crucial to follow the dosage instructions provided by your child’s healthcare provider, as the appropriate dose may vary based on factors such as age and weight.

Can I take Unisom while pregnant or breastfeeding?

Pregnant or breastfeeding women should consult their healthcare provider before using Unisom, as the safety of the medication during pregnancy and lactation has not been fully established.

Unisom – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Diphenhydramine belongs to a group of medications known as antihistamines. Antihistamines are used to treat symptoms caused by allergies, including itchy and watery eyes, sneezing, runny nose, and skin irritation. Diphenhydramine also causes drowsiness, and can be used by adults and children 12 years of age and older who occasionally have trouble sleeping (insomnia). The effects of diphenhydramine can last for up to 6 hours.

If you have trouble sleeping, do not take this medication for more than a few nights in a row. Talk to your doctor about other treatment options suitable for you if you have chronic (long-term) insomnia that persists for more than a few nights at a time.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

25 mg SleepGels
Each capsule contains 25 mg of diphenhydramine HCl. Nonmedicinal ingredients: gelatin, glycerin, polyethylene glycol, purified water, sorbitol, soy lecithin, and titanium dioxide.

50 mg
Each tablet contains 50 mg of diphenhydramine HCl. Nonmedicinal ingredients: calcium phosphate, cellulose, FD&C Blue No. 1 Aluminum Lake, hypromellose, magnesium stearate, polyethylene glycol, and sodium starch glycolate.

50 mg SleepGels
Each capsule contains 50 mg of diphenhydramine HCl. Nonmedicinal ingredients: FD&C Blue No. 1 Aluminum Lake, gelatin, glycerin, Opacode solution, polyethylene glycol, sorbitol, and water.

How should I use this medication?

The usual dose for adults and children 12 years of age and older to help with sleep is 25 mg to 50 mg taken by mouth at bedtime. Some people may only need to take 25 mg at bedtime if they are drowsy in the morning (e.g., they find it interferes with their daily activities) after taking the 50 mg dose.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to diphenhydramine or any ingredients of the medication
  • have an enlarged prostate
  • have an obstructed bladder
  • have asthma or chronic lung disease
  • have certain stomach conditions (e.g., stenosing peptic ulcer or pyloroduodenal obstruction)
  • have narrow-angle glaucoma
  • have taken an antidepressant medication known as a MAO inhibitor (e.g., phenelzine, tranylcypromine, linezolid) within the past 2 weeks

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • chest congestion
  • constipation
  • dizziness
  • drowsiness
  • dry mouth, nose, and throat
  • headache
  • inability to concentrate
  • increased perspiration
  • nausea or vomiting
  • restlessness
  • upset stomach

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • decreased muscle coordination
  • difficulty in passing urine
  • excitation (especially in children)
  • insomnia
  • muscle weakness
  • nervousness
  • rapid heart rate
  • vision problems

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • chest tightness
  • skin rash or hives
  • wheezing

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bladder or urinary problems: Diphenhydramine can worsen symptoms of bladder problems. If you have a history of bladder problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Avoid driving or operating machinery until you have determined that you do not become drowsy during the day or experience impaired mental or physical abilities while taking this medication. Alcohol, sedatives, and pain medications can increase the side effects (e.g., drowsiness, inability to concentrate) of this medication. Do not undertake any activities that require alertness until you know how this medication affects you.

High blood pressure: If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lung problems: This medication can make breathing problems worse. If you have lung problems such as asthma or chronic obstructive pulmonary disease (COPD), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medical conditions: For some people, insomnia is caused by other medical conditions. If you have trouble sleeping for longer than 2 weeks, contact your doctor before taking this medication.

Thyroid disease: People with thyroid disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking diphenhydramine, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Diphenhydramine is not recommended for use as a sleep aid for children less than 12 years of age.

Seniors: Seniors may experience more side effects with this medication. Talk to your doctor before taking this medication.

What other drugs could interact with this medication?

There may be an interaction between diphenhydramine and any of the following:

  • aclidinium
  • alcohol
  • alfuzosin
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • atomoxetine
  • atropine
  • azelastine
  • barbiturates (e. g., butalbital, pentobarbital, phenobarbital)
  • belladonna
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • benztropine
  • botulinum toxins
  • brimonidine
  • buprenorphine
  • buspirone
  • captopril
  • carvedilol
  • chloral hydrate
  • chloroquine
  • cyclobenzaprine
  • degarelix
  • dextromethorphan
  • disopyramide
  • dofetilide
  • domperidone
  • donepezil
  • doxorubicin
  • dronabinol
  • dronedarone
  • efavirenz
  • flavoxate
  • flecainide
  • galantamine
  • general anesthetics (medications used to put people to sleep before surgery)
  • glycopyrrolate
  • hyaluronidase
  • ipratropium
  • ketotifen
  • lopinavir
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • magnesium sulfate
  • methadone
  • methamphetamine
  • metoprolol
  • mexiletine
  • mifepristone
  • minocycline
  • mirabegron
  • mirtazapine
  • muscle relaxants (e. g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • nabilone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nefazodone
  • olopatadine
  • other antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • oxybutynin
  • perampanel
  • pimozide
  • potassium chloride
  • pramipexole
  • procainamide
  • quinidine
  • quinine
  • quinolone antibiotics (e.g., ciprofloxacin, ofloxacin, sparfloxacin)
  • rilpivirine
  • rivastigmine
  • ropinirole
  • rotigotine
  • rufinamide
  • scopolamine
  • secretin
  • seizure medications (e.g., clobazam, ethosuximide, felbamate, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
  • serotonin agonists (e. g., dolasetron, granisetron, ondansetron)
  • sotalol
  • tamoxifen
  • tapentadol
  • thalidomide
  • timolol
  • tiotropium
  • tolterodine
  • topiramate
  • tramadol
  • tranylcypromine
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, imipramine, nortriptyline)
  • tyrosine kinase inhbitors (e.g., lapatinib, pazopanib, sunitinib)
  • umeclidinium
  • venlafaxine
  • voriconazole
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2021. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Unisom

Doxylamine Not Recommended for Insomnia Treatment

Doxylamine is a sleep aid found in over-the-counter products such as Unisom and Nyquil. It’s sometimes taken to treat insomnia.

Like the related medication diphenhydramine, doxylamine does not require a prescription. That doesn’t mean it doesn’t come with potential side effects, though. Before taking doxylamine, you should learn how well it works and what problems it can cause.

Verywell / Jessica Olah 

Uses

Doxylamine is an antihistamine, meaning that it treats allergies. It’s also used for nighttime cold symptoms. Causing drowsiness is considered a side effect, but it can be a useful one for some people who need help getting to sleep or staying asleep. It shouldn’t be used for more than two weeks to treat insomnia.

Like many sleeping pills, doxylamine affects neurotransmittersspecialized chemical messengers that send signals between brain and nerve cells (neurons). More specifically, it blocks receptors that allow the neurotransmitter histamine to affect a neuron. This causes you to get sleepy.

Doxylamine works centrally (within the central nervous system) and elsewhere in the body to sedate you.

Before Taking

As an over-the-counter medication, the risks are thought to be slightly lower than with prescription medications that require more careful monitoring. No routine tests are recommended with its use.

Ultimately, doxylamine is not the best option if you are considering taking sleeping pills; there are a number of other choices that are better suited to aiding sleep. Doxylamine doesn’t promote sleep in the same way as prescription hypnotic medications, such as benzodiazepine and non-benzodiazepine medications.

To take a medication for its side effect—in this case, sleepiness—is not recommended.

Doxylamine is non-habit forming medication. However, you can develop tolerance to it and take more than needed.

Precautions and Contraindications

Doxylamine is contraindicated for various groups.

Age Restrictions

Children under 12 years of age should not use doxylamine 25 milligrams (mg). Children under 6 and elderly patients shouldn’t use it without a healthcare provider’s advice.

Breastfeeding

According to a National Institutes of Health publication, small, occasional doses shouldn’t cause problems with breastfed babies. However, larger doses or long-term use may cause drowsiness, irritability, and colicky symptoms in babies. It may also lower your milk supply.

Medical Conditions

People with many conditions should be cautious about doxylamine as it may cause problems or drug interactions. These conditions include:

  • Glaucoma
  • Hyperthyroidism
  • Heart disease
  • High blood pressure (hypertension)
  • Asthma
  • Chronic obstructive pulmonary disease (COPD)
  • Pneumonia
  • Peptic ulcer disease
  • Prostate enlargement
  • Liver disease
  • Bowel or bladder obstruction

If you’re concerned about whether you may have problems using doxylamine, you should first consult with your healthcare provider.

Negative drug interactions are also a risk, especially with other medications that affect the brain, so be sure to review your medications with your healthcare provider or pharmacist before starting to use doxylamine.

Side Effects

The list of potential side effects for any drug can be quite long, and doxylamine is no exception. Although you likely wouldn’t experience most side effects, and may not have any at all, some that occur commonly with doxylamine include:

  • Dizziness
  • Loss of coordination
  • Headache
  • Stomach pain
  • Dry mouth or nose
  • Constipation
  • Difficulty urinating
  • Blurred or double vision

Potential Serious Reactions

While they’re rare, serious side effects can result from the use of doxylamine, including:

  • Severe allergic reaction, including difficulty breathing (anaphylaxis)
  • Low blood cell counts (agranulocytosis, anemia, thrombocytopenia, and leukopenia)
  • Abnormal heart rhythms or altered heart rate
  • Seizures
  • Toxic psychosis
  • Inner ear problems (acute labyrinthitis)
  • Hallucinations
  • Confusion or delirium
  • Low blood pressure
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A Word From Verywell

If you experience any difficulties when taking this drug, you should be in close contact with your primary health provider. If you wish to pursue preferred treatments for insomnia, you should likewise make an appointment and discuss the better prescription options that are available.

Effective treatment may include medications, learning better sleep habits, or cognitive behavioral therapy for insomnia (CBTI).

Frequently Asked Questions

  • Can I take Unisom every night?

    No. Unisom is intended as a temporary sleep aid and should not be taken for more than two weeks. If you need ongoing help falling asleep, speak to your healthcare provider.  

  • Does Unisom help with morning sickness?

    Yes. The doxylamine succinate in Unisom taken with vitamin B6 can treat morning sickness during pregnancy. Talk to your healthcare provider before taking the combination to be sure it’s right for you.

  • Why is doxylamine not recommended for older adults?

    Doxylamine may increase the risk for dementia. This is due to its anticholinergic properties, which means it blocks neurotransmitters that transmit messages along the nervous system. According to researchers, anticholinergics are associated with cognitive decline.

The Risks of Taking Sleeping Pills

Erratic Behavior Side Effects

We’ve all been known to do strange things in our sleep, but prescription sleeping pills, particularly benzodiazepines such as triazolam, have been known to cause side effects like sleepwalking and amnesia. “You’ll wake up, and you won’t know where you are,” Leavey says. This has also been seen in people who have taken the newer sleep aids like Ambien. If you (or your significant other) notice evidence of strange behavior while you’re taking sleeping pills, report these problems with sleeping pills to your doctor promptly. 

Falling Down 

Hospital patients who took zolpidem were four times more likely to fall than those who did not take the drug during their hospital stay, according to a recent study published in the Journal of Hospital Medicine. “Falling is absolutely a problem,” Leavey says. “Your entire body is balanced on two little feet. You have sensors on your feet that constantly measure your center of gravity and where you are. If I give you a drug that dulls that system, you’ll fall down.” Older patients are particularly at risk for this problem with sleeping pills, he adds.

Cancer and Death

People who took prescription sleeping pills were more likely to die or get cancer than those who did not take them, according to a 2012 study published in BMJ Open. Though the results are concerning, they don’t necessarily mean that these drugs definitely cause negative side effects. “I would really want to see more evidence on that one,” Leavey says. The study’s authors suggest that cognitive behavioral therapy, a type of treatment that helps you change your thinking patterns, could be a better treatment for chronic insomnia than drugs.

You May Have Trouble Weaning Off Sleeping Pills

Once you begin taking sleeping pills, it can be hard to stop, particularly if you’ve been taking them for a long time. Some people experience “rebound insomnia” — when sleeping problems actually worsen once you stop taking the drug. If you want to go off your sleeping pills, talk to your doctor about setting up a schedule to gradually reduce your dosage, rather than just quitting cold turkey. “It may be rough coming off, but things will eventually get better,” Leavey says.

Frequently Asked Questions – Unisom OTC Sleep-Aids

Frequently Asked Questions – Unisom OTC Sleep-Aids

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Home Frequently Asked Questions

What is the appropriate dose for Unisom?

For Unisom SleepGels®, SleepTabs® or PM Pain, please take one. If you are taking Unisom SleepMeltsTM or SleepMinisTM, please take two. For Unisom Simple Slumbers, please take two gummies. Always refer to the directions located on the back label of all Unisom products. We do not recommend any other dosage amounts.

Can I build up a tolerance and become resistant to Unisom products?

It is possible that after long-term use you could become resistant to the sedation (sleepiness) from Unisom. However, the package states that you should not use Unisom for sleep for more than 14 days unless recommended by your doctor, for OTC Sleep Aid Products.

What are the Unisom active ingredients?

SleepGels: The active sleep-aid ingredient is diphenhydramine HCl (50 mg/dose).
SleepTabs: SleepTabs contain doxylamine succinate (25 mg/dose).
SleepMinis: The active sleep-aid ingredient is Diphenhydramine HCl (50 mg/dose).
SleepMelts: The active sleep-aid ingredient is diphenhydramine HCl (50 mg/dose).
PM Pain: The active sleep-aid ingredient is diphenhydramine HCl (50 mg/dose).  PM Pain also contains the pain reliever acetaminophen (325 mg/dose).
Simple Slumbers: The supplement ingredient is melatonin (5 mg/dose).

Will I become addicted to Unisom?

No. The products are non-habit forming and safe when used as directed.

What are the potential side effects of taking Unisom?

Potential Unisom side effects for diphenhydramine HCl and doxylamine succinate products are similar and might include daytime drowsiness, dry mouth, dizziness, and memory problems.1 If you experience any of these side effects, discontinue use and consult your doctor. See each product’s drug facts for full warning information.

Can I take Unisom for an allergy?

No. Your Unisom nighttime sleep aid is just that: a nighttime sleep aid. Although the active ingredient is an antihistamine, the dosing frequency and directions may differ between its sleep-aid use and the allergy use.   Therefore, it is advised you speak to your doctor or healthcare professional regarding allergy symptoms.

Is Unisom safe when used as directed and effective?

All Unisom formulas are safe when used as directed.

What sizes are available?

Unisom SleepTabs are available in 16, 32, 48 and 80 count sizes. All sizes are in child-resistant packaging. The 16 count is packaged in a blister card. All other sizes are available in bottles.
Unisom SleepGels are available in 8, 16, 32, 60 and 100 count sizes. All sizes are in child-resistant packaging. The 8 and 16 count are packaged in blister cards. All other sizes are available in bottles.
Unisom SleepMinis are available in a 60 count child-resistant bottle.
Unisom SleepMelts are available in 24 count child-resistant blister cards.
Unisom PM Pain is available in 15 and 30 count child-resistant bottles.
Unisom Simple Slumbers is available in a 60 and 120 count child-resistant bottles.

Should I consult my doctor first?

Before using any OTC product, you should always read the back label to determine if you have any pre-existing medical conditions that require you to first consult your doctor.

Will Unisom interact with my medications?

If you are currently taking any other medication, we recommend consulting a doctor or pharmacist regarding possible drug interactions.

Can I take Unisom every night?

Unisom is for occasional sleeplessness only. If your sleeplessness persists for more than two weeks, consult your doctor. Sleeplessness may be a symptom of serious underlying medical illness.

Can I take Unisom if I wake up in the middle of the night?

It is recommended that you take Unisom SleepTabs 30 minutes before going to bed for the evening. Unisom SleepMinis, SleepGels, SleepMelts, PM Pain and Simple Slumbers should be taken at bedtime. Taking the product too late at night may cause some morning drowsiness.

When should I take Unisom?

SleepGels: For adults and children 12 years of age and over, 1 softgel should be taken at bedtime if needed, or as directed by a doctor.
SleepTabs: For adults 12 years of age and older, 1 tablet should be taken 30 minutes before going to bed, or as directed by a doctor
SleepMinis: For adults 12 years of age and older, 2 mini-capsules should be taken at bedtime if needed, or as directed by a doctor
SleepMelts: For adults and children 12 years of age and over, 2 tablets should be taken at bedtime if needed, or as directed by a doctor.
PM Pain: For adults and children 12 years of age and older, 1 caplet should be taken at bedtime, or as directed by a doctor.
Simple Slumbers: For adults and children 18 years of age or older, 2 gummies should be taken before bedtime, or as directed by a doctor.

How do Unisom products work?

Unisom SleepGels, SleepMelts, SleepMinis and PM Pain contain diphenhydramine HCl. It works by blocking the effects of a naturally occurring neurotransmitter your body makes called histamine. When histamine is reduced, you experience drowsiness, which allows you to fall asleep faster and stay asleep.

SleepTabs’ active ingredient, doxylamine succinate, is a non-habit forming antihistamine that blocks certain natural substances (histamine, acetylcholine) that your body makes. The lack of histamine causes you to get drowsy and fall asleep quicker. As a result, you’ll get a good night’s sleep from Unisom tablets.

Simple Slumbers is 100% drug free and contains 5 mg of melatonin for a good night’s sleep. Simple Slumbers contains a proprietary blend of melatonin with passionflower, lemonbalm, and vitamin B6. Melatonin provides a triple effect by allowing you to fall asleep fast, sleep soundly and wake refreshed. Melatonin works naturally with the body to regulate the sleep-wake cycle by physiologically signaling to the body that it is time to sleep—causing drowsiness and lowering body temperature. Melatonin promotes sleep in a way that resembles the natural onset of sleep—through quiet wakefulness to the sleeping state, while maintaining normal sleep cycle. By providing 5 mg of melatonin, Unisom Simple Slumbers supplements the body’s natural sleep process to help you fall asleep.*

How fast will Unisom products make me fall asleep?

While this varies with the individual, our study shows that Unisom SleepTabs help people with occasional sleeplessness to fall asleep 33% faster than without Unisom.**

Will I remain asleep all night if I take Unisom products?

Studies show that Unisom helps troubled sleepers sleep soundly through the night. However, like any OTC aid, results may vary.

Why does Unisom make my mouth dry?

This is a side effect of the antihistamine. When you stop taking Unisom, this side effect will go away.

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Sleep aids: Understand over-the-counter options

Sleep aids: Understand over-the-counter options

Trouble sleeping? Over-the-counter sleep aids might help temporarily — but lifestyle changes are usually the best approach for chronic insomnia.

By Mayo Clinic Staff

You’ve followed the usual tips for getting enough sleep — sleeping on a regular schedule, avoiding caffeine and daytime naps, exercising regularly, avoiding lighted screens before bed, and managing stress. Still, it’s been weeks and a good night’s sleep remains elusive. Is it time for an over-the-counter sleep aid? Here’s what you need to know if you’re considering medication to help you sleep.

Sleep aids: Not a magic cure

Over-the-counter sleep aids can be effective for an occasional sleepless night. There are a few caveats, however.

Most over-the-counter sleep aids contain antihistamines. Tolerance to the sedative effects of antihistamines can develop quickly — so the longer you take them, the less likely they are to make you sleepy.

In addition, some over-the-counter sleep aids can leave you feeling groggy and unwell the next day. This is the so-called hangover effect.

Medication interactions are possible as well, and much remains unknown about the safety and effectiveness of over-the-counter sleep aids.

Sleep aids: The options

Over-the-counter sleep aids are widely available. Common choices and the potential side effects include:

  • Diphenhydramine (Benadryl, Aleve PM, others). Diphenhydramine is a sedating antihistamine. Side effects might include daytime drowsiness, dry mouth, blurred vision, constipation and urinary retention.
  • Doxylamine succinate (Unisom SleepTabs). Doxylamine is also a sedating antihistamine. Side effects are similar to those of diphenhydramine.
  • Melatonin. The hormone melatonin helps control your natural sleep-wake cycle. Some research suggests that melatonin supplements might be helpful in treating jet lag or reducing the time it takes to fall asleep — although the effect is typically mild. Side effects can include headaches and daytime sleepiness.
  • Valerian. Supplements made from this plant are sometimes taken as sleep aids. Although a few studies indicate some therapeutic benefit, other studies haven’t found the same benefits. Valerian generally doesn’t appear to cause side effects.

Store brands containing the same active ingredients as brand-name sleep aids are commonly available, too. Store brands have the same risks and benefits as their brand-name counterparts, often at a more reasonable cost.

Important precautions

When using over-the-counter sleep aids, follow these steps:

  • Start with your doctor. Ask your doctor if the sleep aid might interact with other medications or underlying conditions, and what dosage to take.
  • Keep precautions in mind. Diphenhydramine and doxylamine aren’t recommended for people who have closed-angle glaucoma, asthma, chronic obstructive pulmonary disease, sleep apnea, severe liver disease, digestive system obstruction or urinary retention. In addition, sleep aids pose risks for women who are pregnant or breast-feeding, and might pose risks to people over age 75, including an increased risk of strokes and dementia.
  • Take it one day at a time. Over-the-counter sleep aids are a temporary solution for insomnia. Generally, they’re not intended to be used for longer than two weeks.
  • Avoid alcohol. Never mix alcohol and sleep aids. Alcohol can increase the sedative effects of the medication.
  • Beware of side effects. Don’t drive or attempt other activities that require alertness while taking sleep aids.

Everyone benefits from a good night’s sleep. If you continue to have trouble sleeping, talk to your doctor. In addition to lifestyle changes, he or she might recommend behavior therapy to help you learn new sleep habits and ways to make your sleeping environment more conducive to sleep. In some cases, short-term use of prescription sleep aids might be recommended as well.

Oct. 16, 2019

Show references

  1. Bonnet MH, et al. Treatment of insomnia in adults. https://www.uptodate.com/com/contents/search. Accessed Jan. 9, 2018.
  2. Schroeck JL, et al. Review of safety and efficacy of sleep medicines in older adults. Clinical Therapeutics. 2016;38:2340.
  3. Culpepper L, et al. Over-the-counter agents for the treatment of occasional disturbed sleep or transient insomnia: A systematic review of efficacy and safety. The Primary Care Companion for CNS Disorders. 2015;17:1. http://www.psychiatrist.com/PCC/article/Pages/2015/v17n06/15r01798.aspx. Accessed Jan. 9, 2018.
  4. Kryger MH, et al., eds. Pharmacologic treatment of insomnia: Other medications. In: Principles and Practice of Sleep Medicine. 6th ed. St. Louis, Mo.: Elsevier Saunders; 2017. https://www.clinicalkey.com. Accessed Jan. 3, 2018.
  5. Petrov ME, et al. Over-the-counter and prescription sleep medication and incident stroke: The Reasons for Geographic and Racial Differences in Stroke study. Journal of Stroke and Cardiovascular Disease. 2014;23:2110.
  6. Valerian. Natural Medicines. https://naturalmedicines. therapeuticresearch.com. Accessed Jan. 9, 2018.
  7. Ferri FF. Insomnia. In: Ferri’s Clinical Advisor 2018. Philadelphia, Pa.: Elsevier; 2018. https://www.clinicalkey.com. Accessed Jan. 10, 2018.
  8. Melatonin. Natural Medicines. https://naturalmedicines.therapeuticresearch.com. Accessed Jan. 10, 2018.
  9. Dauphinot V, et al. Anticholinergic drugs and functional, cognitive impairment and behavioral disturbances in patients from a memory clinic with subjective cognitive decline or neurocognitive disorders. Alzheimer’s Research and Therapy. 2017;9:58.
  10. Rochon PA. Drug prescribing for older adults. https://www.uptodate.com/contents/search. Accessed Jan. 9, 2018.

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Doxylamine: MedlinePlus Drug Information

Doxylamine comes as a tablet to take by mouth for sleep, and in combination with other medications as a liquid and liquid-filled capsule to treat symptoms of the common cold. When doxylamine is used to reduce difficulty falling asleep, it usually is taken 30 minutes before bedtime. When doxylamine is used to treat cold symptoms, it is usually taken every 4 to 6 hours. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take doxylamine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor or directed on the package label.

Doxylamine comes alone and in combination with pain relievers, fever reducers, and cough suppressants, If you are choosing a product to treat cough or cold symptoms, ask your doctor or pharmacist for advice on which product is best for your symptoms. Check nonprescription cough and cold product labels carefully before using two or more products at the same time. These products may contain the same active ingredient(s) and taking them together could cause you to receive an overdose.

Nonprescription cough and cold combination products, including products that contain doxylamine, can cause serious side effects or death in young children. Do not give nonprescription products that contain doxylamine to children younger than 4 years of age. Ask a doctor before giving these products to children 4 to 12 years of age.

Cough and cold symptoms that get worse or that do not go away may be signs of a more serious condition. If you are taking doxylamine in combination with other medications to treat cough and cold symptoms, call your doctor if your symptoms worsen or if they last longer than 7 days.

If you are taking doxylamine to treat insomnia, you will probably become very sleepy soon after you take the medication and will remain sleepy for some time after you take the medication. Plan to remain asleep for 7 to 8 hours after taking the medication. If you get up too soon after taking doxylamine, you may be drowsy.

Doxylamine should only be used to treat insomnia for a short time. Call your doctor if you feel that you need to take doxylamine for longer than 2 weeks.

If you are using the liquid, do not use a household spoon to measure your dose. Use the measuring cup or spoon that came with the medication or use a spoon that is made especially for measuring medication.

Sleeping Pills and Natural Sleep Aids

sleep

All you need to know about prescription and over-the-counter sleep medications—as well as effective insomnia treatments that don’t come in pill form.

Are sleeping pills or sleep aids right for you?

It’s the middle of the night, and you’re staring at the ceiling, thinking about work, or bills, or the kids. When sleep just won’t come, it’s tempting to turn to a sleeping pill or sleep aid for relief. And you may get it in the moment. But if you regularly have trouble sleeping, that’s a red flag that something’s wrong. It could be something as simple as too much caffeine or viewing TV, your phone, or other screens late at night. Or it may be a symptom of an underlying medical or psychological problem. But whatever it is, it won’t be cured with sleeping pills. At best, sleeping pills are a temporary band aid. At worst, they’re an addictive crutch that can make insomnia worse in the long run.

That doesn’t mean that you should never use medication, but it’s important to weigh the benefits against the risks. In general, sleeping pills and sleep aids are most effective when used sparingly for short-term situations, such as traveling across time zones or recovering from a medical procedure. If you choose to take sleeping pills over the long term, it is best to use them only on an infrequent, “as needed” basis to avoid dependence and tolerance.

Risks and side effects of sleeping pills

All prescription sleeping pills have side effects, which vary depending on the specific drug, the dosage, and how long the drug lasts in your system. Common side effects include prolonged drowsiness the next day, headache, muscle aches, constipation, dry mouth, trouble concentrating, dizziness, unsteadiness, and rebound insomnia.

Other risks of sleeping pills 

Drug tolerance. You may, over a period of time, build up a tolerance to sleep aids, and you will have to take more and more for them to work, which in turn can lead to more side effects.

Drug dependence. You may come to rely on sleeping pills to sleep, and will be unable to sleep or have even worse sleep without them. Prescription pills, in particular, can be very addictive, making it difficult to stop taking them.

Withdrawal symptoms. If you stop the medication abruptly, you may have withdrawal symptoms, such as nausea, sweating, and shaking.

Drug interactions. Sleeping pills can interact with other medications. This can worsen side effects and sometimes be dangerous, especially with prescription painkillers and other sedatives.

Rebound insomnia. If you need to stop taking sleeping pills, sometimes the insomnia can become even worse than before.

Masking an underlying problem. There may be an underlying medical or mental disorder, or even a sleep disorder, causing your insomnia that can’t be treated with sleeping pills.

Some serious risks of sleeping pills

Sedative-hypnotic medications (benzodiazepines and non-benzodiazepines) can cause severe allergic reaction, facial swelling, memory lapses, hallucinations, suicidal thoughts or actions, and complex sleep-related behaviors like sleep-walking, sleep-driving (driving while not fully awake, with no memory of the event) and sleep-eating (eating in the middle of the night with no recollection, often resulting in weight-gain). If you experience any unusual sleep-related behavior, consult your doctor immediately.

Over-the-counter (OTC) sleep aids and sleeping pills

Standard over-the-counter sleeping pills rely on antihistamines as their primary active ingredient to promote drowsiness.

Common over-the-counter sleep medications include:

  • Diphenhydramine (found in brand names like Nytol, Sominex, Sleepinal, Compoz)
  • Doxylamine (brand names such as Unisom, Nighttime Sleep Aid)

Some other OTC sleep aids combine antihistamines with the pain reliever acetaminophen (found in brand names like Tylenol PM). Others, such as NyQuil, combine antihistamines with alcohol.

The problem with antihistamines is that their sedating properties often last well into the next day, leading to a next-day hangover effect. When used long-term, they can also cause forgetfulness and headaches. Because of these issues, sleep experts advise against their regular use.

Common side effects of antihistamine sleeping pills
  • Moderate to severe drowsiness the next day.
  • Dizziness and forgetfulness.
  • Clumsiness, feeling off balance.
  • Constipation and urinary retention.
  • Blurred vision.
  • Dry mouth and throat.
  • Nausea.

Prescription sleep medications

There are several different types of prescription sleeping pills, classified as sedative hypnotics. In general, these medications act by working on receptors in the brain to slow down the nervous system. Some medications are used more for inducing sleep, while others are used for staying asleep. Some last longer than others in your system (a longer half-life), and some have a higher risk of becoming habit forming.

Benzodiazepine sedative hypnotic sleeping pills

Benzodiazepines are the oldest class of sleep medications still commonly in use. Benzodiazepines as a group are thought to have a higher risk of dependence than other insomnia sedative hypnotics and are classified as controlled substances. Primarily used to treat anxiety disorders, benzodiazepines that have been approved to treat insomnia include estazolam (brand name ProSom), flurazepam (Dalmane), quazepam (Doral), temazepam (Restoril), and triazolam (Halcion).

Drawbacks to benzodiazepine sleeping pills

You can become both physically and psychologically dependent on benzodiazepines. When you’re on the pills for a period of time, you may believe that you can’t sleep without them, and once you stop taking them, you may actually experience physical withdrawal symptoms like anxiety and rebound insomnia.

Sleeping pills can lose their effectiveness if used on a nightly basis, because the brain receptors become less sensitive to their effects. In as little as three to four weeks, benzodiazepines can become no more effective than a sugar pill.

The overall quality of your sleep can be reduced, with less restorative deep sleep and REM sleep.

You may experience next day cognitive slowing and drowsiness (the hangover effect), which may be even worse than the sluggishness you feel from actual sleep deprivation.

Insomnia returns once you stop, even if the medication is effective while taking it. As with the use of all sleeping pills, rather than dealing with your insomnia, you’re merely postponing the problem.

There may be a link to dementia. While it’s currently under investigation, there is concern that using benzodiazepines may contribute to the development of dementia.

Non-benzodiazepine sedative hypnotic sleeping pills

Some newer medications don’t have the same chemical structure as a benzodiazepine, but act on the same area in the brain. They are thought to have fewer side effects, and less risk of dependency, but are still considered controlled substances. They include zalepon (Sonata), zolpidem (Ambien), and eszopiclone (Lunesta), which have been tested for longer-term use, up to six months.

Drawbacks to non-benzodiazepine sleeping pills

Generally, non-benzodiazepines have fewer drawbacks than benzodiazepines, but that doesn’t make them suitable for everyone. Some may find this type of sleep medication ineffective at helping them sleep, while the long-term effects remain unknown.

The U.S. Food and Drug Administration (FDA) recently directed the manufacturers of Ambien and similar sleeping pills to lower the standard dosage due to the serious risk of morning grogginess while driving, especially in women patients. Other side effects include:

  • Drug tolerance.
  • Rebound insomnia.
  • Headaches, dizziness, nausea, difficulty swallowing or breathing.
  • In some cases, dangerous sleep-related behaviors such as sleep-walking, sleep-driving, and sleep-eating.
  • New or worsening depression; suicidal thoughts or actions.

Melatonin receptor agonist hypnotic sleeping pills

Ramelteon (Rozerem) is the newest type of sleep medication and works by mimicking the sleep regulation hormone melatonin. It has little risk of physical dependency but still has side effects. It is used for sleep onset problems and is not effective for problems regarding staying asleep.

Ramelteon’s most common side effect is dizziness. It may also worsen symptoms of depression and should not be used by those with severe liver damage.

Antidepressants used as sleeping pills

The FDA has not approved antidepressants for the treatment of insomnia, nor has their use been proven effective in treating sleeplessness. However, some antidepressants are prescribed off-label due to their sedating effects. As with all depression medication, there is a small but significant risk of suicidal thoughts or worsening of depression, particularly in children and adolescents.

Herbal and dietary sleep supplements that may help

Go to the drugstore and you’ll see dozens of so-called “natural” sleep supplements. The FDA doesn’t regulate dietary supplements for safety, quality, effectiveness, or even truth in labeling, so it’s up to you to do your due diligence. Although the evidence is mixed, the following supplements have the most research backing them up as insomnia treatments:

Valerian. Valerian is a sedating herb that has been used since the second century A.D. to treat insomnia and anxiety. It is believed to work by increasing brain levels of the calming chemical GABA. Although the use of valerian for insomnia hasn’t been extensively studied, the research shows promise and it is generally considered to be safe and non-habit forming. It works best when taken daily for two or more weeks.

Melatonin. Melatonin is a naturally occurring hormone that increases at night. It is triggered by darkness and its levels remain elevated throughout the night until suppressed by the light of morning. Although melatonin does not appear to be particularly effective for treating most sleep disorders, it can help sleep problems caused by jet lag and shift work. Simple exposure to light at the right time, however, might be just as effective. If you take melatonin, be aware that it can interfere with certain blood pressure and diabetes medications. It’s best to stick with low doses—one to three milligrams for most people—to minimize side effects and next-day drowsiness.

Chamomile. Many people drink chamomile tea for its gentle sedative properties, although it may cause allergic reactions in those with plant or pollen allergies. To get the full sleep-promoting benefit, bring water to a boil, then add two to three tea bags (or the equivalent of loose-leaf tea), cover with a lid, and brew for ten minutes.

Tryptophan. Tryptophan is a basic amino acid used in the formation of the chemical messenger serotonin, a substance in the brain that helps tell your body to sleep. L-tryptophan is a common byproduct of tryptophan, which the body can change into serotonin. Some studies have shown that L-tryptophan can help people fall asleep faster. Results, however, have been inconsistent.

Kava. Kava has been shown to improve sleep in people with stress-related insomnia. However, kava can cause liver damage, so it isn’t recommended unless taken under close medical supervision.

Other herbs that have been found to have a calming or sedating effect include lemon balm, passionflower, and lavender. Many natural sleep supplements use a combination of these ingredients to promote sleep.

Natural doesn’t mean safe

While some remedies, such as lemon balm or chamomile tea are generally harmless, others can have more serious side effects and interfere with or reduce the effectiveness of prescribed medications. Valerian, for example, can interfere with antihistamines and statins. Do your research before trying a new herbal remedy and talk with your doctor or pharmacist if you have any pre-existing conditions or prescriptions that you take.

Tips for safer use of sleeping pills

If you decide to try sleeping pills or sleep aids, keep the following safety guidelines in mind.

Never mix sleeping pills with alcohol or other sedative drugs. Alcohol not only disrupts sleep quality, but it increases the sedative effects of sleeping pills. The combination can be quite dangerous—even deadly.

Only take a sleeping pill when you will have enough time for at least seven to eight hours of sleep. Otherwise you may feel very drowsy the next day.

Don’t take a second dose in the middle of the night. It can be dangerous to double up on your dosage, and with less time for the medication to clear your system it may be difficult to get up the next morning and shake off grogginess.

Start with the lowest recommended dose. See how the medication affects you and the types of side effects you experience.

Avoid frequent use. To avoid dependency and minimize adverse effects, try to save sleeping pills for emergencies, rather than nightly use.

Never drive a car or operate machinery after taking a sleeping pill. This tip is especially important when you start using a new sleep aid, as you may not know how it will affect you.

Carefully read the package insert that comes with your medication. Pay careful attention to the potential side effects and drug interactions. Many common medications, including antidepressants and antibiotics, can cause dangerous interactions with both prescription and over-the-counter sleeping pills. For many sleeping pills, certain foods such as grapefruit and grapefruit juice must also be avoided.

Before taking sleeping pills …

Talk to your doctor or pharmacist about:

  • Other medications and supplements you are taking. Many common medications, including antidepressants and antibiotics, can cause dangerous interactions with both prescription and over-the-counter sleeping pills. Herbal and dietary supplements and non-prescription medications such as pain relievers and allergy medicines may also interfere.
  • Other medical conditions you have. Some sleep medications can have serious side effects for people with medical problems such as high blood pressure, liver problems, glaucoma, depression, and breathing difficulties.
  • Specific instructions for increasing, decreasing and/or terminating use. It’s important to follow usage directions closely. Increasing your dose may pose risks, but decreasing your use can also cause problems if done too quickly. In some cases, stopping medication abruptly can cause uncomfortable side effects and even rebound insomnia.

For better sleep, opt for healthy habits, not pills

Research has shown that changing your lifestyle and sleep habits is the best way to combat insomnia. Even if you decide to use sleeping pills or medications in the short term, experts recommend making changes to your lifestyle and bedtime behavior as a long-term remedy to sleep problems. Behavioral and environmental changes can have more of a positive impact on sleep than medication, without the risk of side effects or dependence.

Relaxation techniques as an alternative to sleeping pills

Relaxation techniques that can relieve stress and help you sleep include simple meditation practices, progressive muscle relaxation, yoga, tai chi, and the use of deep breathing. With a little practice, these skills can help you unwind at bedtime and improve your sleep more effectively than a sleeping pill or sleep aid. Try:

A relaxing bedtime routine. Turn off screens at least one hour before bed and focus on quiet, soothing activities, such as reading, gentle yoga, or listening to soft music instead. Keep the lights low to naturally boost melatonin.

Abdominal breathing. Most of us don’t breathe as deeply as we should. When we breathe deeply and fully, involving not only the chest, but also the belly, lower back, and ribcage, it can actually help the part of our nervous system that controls relaxation. Close your eyes and try taking deep, slow breaths, making each breath even deeper than the last. Breathe in through your nose and out through your mouth. Make each exhale a little longer than each inhale.

Progressive muscle relaxation is easier than it sounds. Lie down or make yourself comfortable. Starting with your feet, tense the muscles as tightly as you can. Hold for a count of 10, and then relax. Continue to do this for every muscle group in your body, working your way up to the top of your head.

For a guided progressive muscle relaxation meditation, click here.

Exercise is a powerful sleep aid

Studies have shown that exercise during the day can improve sleep at night. When we exercise, we experience a significant rise in body temperature, followed a few hours later by a significant drop. This drop in body temperature makes it easier for us to fall and stay asleep. The best time to exercise is late afternoon or early evening, rather than just before bed. Aim for at least 30 minutes four times a week. Aerobic exercises are the best to combat insomnia as they increase the amount of oxygen that reaches the blood.

Cognitive behavioral therapy (CBT) beats sleeping pills

Many people complain that frustrating, negative thoughts and worries prevent them from sleeping at night. Cognitive-behavioral therapy (CBT) is a form of psychotherapy that treats problems by modifying negative thoughts, emotions, and patterns of behavior.

A study at Harvard Medical School even found that CBT was more effective at treating chronic insomnia than prescription sleep medication—but without the risks or side effects. CBT can help to relax your mind, change your outlook, improve your daytime habits, and set you up for a good night’s sleep.

Authors: Melinda Smith, M.A., Lawrence Robinson, and Robert Segal, M.A.

Unisom SleepTabs: instruction, composition, description, dosage

Unisom SleepTabs are used as sleeping pills at night and are prescribed for people with insomnia. The drug helps to reduce difficulty falling asleep.

Unisom SleepTabs Instructions for Use

Unisom SleepTabs is a brand name for an over-the-counter drug that contains doxylamine as an active ingredient. The drug is prescribed for people suffering from insomnia.

1. Composition:

Active ingredient: 25 mg doxylamine succinate.

Additional components: dibasic calcium phosphate, food coloring E133 (blue shiny FCF), magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

2. Description:

Unisom SleepTabs belongs to a group of drugs known as antihistamines.

Certain antihistamines, such as doxylamine and diphenhydramine, can cause drowsiness and are often used as sleep aids.

Unisom SleepTabs was approved by the Food and Drug Administration (FDA) as a prescription drug under the brand name Decapryn in 1948.

4. Special instructions:

4.1. Do not take the product in the following cases:

  • You are allergic to doxylamine or any of the other ingredients in this medicine.
  • When breastfeeding.
  • People 65 years of age or older should not take Unisom SleepTabs because it can increase confusion and drowsiness, making people more prone to falls or other accidents.
  • The product should not be given to children under 12 years of age.

4.2. Talk to your doctor before taking Unisom SleepTabs if you have any of the following conditions:

  • High blood pressure.
  • Problems with pressure in the eyes (glaucoma).
  • Asthma, chronic obstructive pulmonary disease (COPD), or breathing problems.
  • Diseases of the stomach or intestines, including ulcers or constipation.
  • Problems with urination.
  • Thyroid disease.

4.3. Pregnancy and breastfeeding

Studies have shown that the use of Unisom SleepTabs in a pregnant woman is unlikely to harm the developing fetus. However, you need to consult a doctor before taking this medication.

When breastfeeding, a woman should not take this remedy, because it can pass into breast milk.

4.4. Interaction with alcohol:

Taking Unisom SleepTabs together with alcohol may cause dry throat, nose and eyes and cause dizziness.

The simultaneous intake of alcohol and sleep pills is not recommended.

4.5. Interaction with grapefruit juice:

The simultaneous use of grapefruit juice and Unisom SleepTabs is not recommended.

5. Rules of admission and dosage:

People who take high doses of Unisom Sleep Tabs should be monitored by a physician.

For best results, take this medicine 30 minutes before bed.

If you have problems with the gastrointestinal tract, you can take sleep tablets after meals.

Dose:

Adults and children 12 years and older take 1 tablet (25 mg) 30 minutes before bedtime with plenty of water.

5.1. Overdose:

If you have taken more than necessary, consult your doctor.

6. Side effects:

Frequent:

  • Drowsiness
  • Dizziness or headache.
  • Dry eyes, dry mouth and / or throat.
  • Blurred vision or double vision.
  • Loss of balance.
  • Problems with urination or constipation.
  • Sweating.
  • Difficulty ejaculating or getting an erection.
  • Stomach discomfort.

Serious side effects (if you find them, you must urgently call a doctor):

  • Fast, rapid, or irregular heartbeat.
  • Convulsions.
  • Bruising or bleeding.
  • Ringing in the ears.
  • Problems with urination.
  • Mood changes, confusion and trouble concentrating.
  • Irritability.
  • Hallucinations.

7. Interaction with other medicinal products

Before taking Unisom SleepTabs, tell your doctor or pharmacist about all medicines you take with or without a prescription, vitamins, supplements and herbs.

Do not use Unisom SleepTabs with the following medicines:

  • Monoamine oxidase inhibitors (MAOIs) such as Marplan (isocarboxazid) and Nardil (phenelzine).
  • Potassium supplements such as KPhos (potassium phosphate and potassium hydrogen phosphate), Klor Con (potassium chloride), Urocit-K (potassium citrate).
  • Anticancer drugs such as matulan (procarbazine).
  • Medicines for Parkinson’s disease such as Azilect (rasagiline), eldepril or Zelepar (selegeline), and Parnate (tranylcypromine).
  • Other antihistamines such as Benadryl (diphenhydramine) or Claritin (loratadine).
  • Medications for sleep or anxiety, such as Valium (Diazepam), Xanax, Klonopin (Clonazepam), or Ambien (Zolpidem).
  • Medicines for mood or depression disorders such as Risperdal (risperidone), Oleptro (trazodone), Trileptal (oxcarbazepine), Invega (paliperidone).
  • Muscle relaxants such as gablofen and lyoresal (baclofen) or soma (carisoprodol).

8. Storage conditions:

Store in closed packaging, at room temperature 20 – 25 about C, out of reach of children and animals.

Do not use after the expiry date printed on the package.

9. Distributor:

Chattem, USA

Instructions for the use of medicines are posted on this site for information purposes.Remember that medications should only be taken on the advice of a doctor.

If you have used this medicine, please leave your feedback below.

Oral Unisom (Doxylamine): Uses, Side Effects, Interactions, Pictures, Warnings and Dosing

Benefits

Benefits

Doxylamine is an antihistamine used to relieve the symptoms of allergies, hay fever and colds. This medication blocks certain naturally occurring substances (histamine, acetylcholine) that your body produces. This effect helps relieve allergy / cold symptoms such as watery eyes, runny nose, and sneezing.

Cough suppressants were not safe or effective in children under 6 years of age. Therefore, do not use this product to treat symptoms of the common cold in children under 6 years of age unless specifically directed by a doctor. Also, do not give 25 mg tablet to children younger than 12 years old unless directed by a doctor. Ask your doctor or pharmacist for more details on the safe use of your product.

These foods do not heal or shorten the duration of the common cold and can cause serious side effects. To reduce the risk of serious side effects, follow all dosage directions carefully. Do not use this product to make your baby sleepy. Do not give other cough and cold medicines that may contain the same or similar ingredients (see also the Drug Interactions section). Ask a doctor or pharmacist about other ways to relieve cough and cold symptoms (for example, drinking enough fluids, using a humidifier or saline / spray)

How to use Unisom SLEEP AID

Read all instructions on the product packaging before taking this medicine. If you have any questions, ask your pharmacist.

Take this medication by mouth with or without food. Follow the dosage directions on the label or take as directed by your healthcare professional. This medicine can be taken with food or milk if the stomach is upset.

If you are using the chewable form of this medicine, chew thoroughly and then swallow.

If you are using the liquid form of this medication, carefully measure the dose with a special measuring instrument / spoon.Don’t use a homemade spoon because you can’t get the right dose.

Do not take more medicines than is recommended, or take them more often without talking to your doctor. Your dosage will depend on your age, health condition, and response to therapy.

Related links

What conditions does Unisom SLEEP AID treat?

Side effects

Side effects

Drowsiness, dizziness, headache, constipation, indigestion, blurred vision, poor coordination, or dry mouth / nose / throat may occur. If any of these effects persist or worsen, contact your doctor or pharmacist immediately.

If your doctor has instructed you to use this medicine, remember that he or she thought the benefit to you was greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental / mood changes (eg, hallucinations, irritability, nervousness, confusion), ringing in the ears, trouble urinating, easy bruising / bleeding , fast / irregular heartbeat.

Get immediate medical attention if you have very serious side effects, including: seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching / swelling (especially of the face / tongue / throat), severe dizziness, trouble breathing.

This is not a complete listing of potential side effects. If you notice other effects not listed above, ask your doctor or pharmacist.

In the USA –

Ask your doctor about side effects. You can report side effects to the FDA by calling 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You can report side effects to Health Canada at 1-866-234-2345.

Related links

List of Unisom SLEEP AID side effects by likelihood and severity.

Precautions

Precautions

Before taking doxylamine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients that may cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medicine, tell your doctor or pharmacist your medical history, especially about: breathing problems (eg asthma, emphysema), certain eye problems (glaucoma), heart problems, high blood pressure, liver disease, seizures, stomach problems (eg, ulcers, blockages), overactive thyroid (hyperthyroidism), urinary problems (eg, urinary problems due to an enlarged prostate, urinary retention).

This drug may make you dizzy or drowsy, or blur your vision. Alcohol or marijuana (cannabis) may make you dizzy or drowsy. Do not drive, use cars, or do anything that requires alertness or clear vision until you can do so safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

To minimize dizziness and lightheadedness, stand up slowly from a sitting or lying position.

Liquid products may contain sugar. Caution is advised if you have diabetes. Ask your doctor or pharmacist about the safe use of this product.

Elderly people may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, low blood pressure, confusion, constipation, or urinary problems. Drowsiness, dizziness, and confusion can increase the risk of falling.

Children may be more sensitive to the effects of antihistamines.In young children, this medicine may cause agitation / agitation instead of drowsiness.

This product is safe to use during pregnancy.

Based on information from related drugs, this drug can pass into breast milk. Talk to your doctor before breastfeeding.

Related links

What should I know about pregnancy, nursing, and UNISOM SLEEP HELP for children or the elderly?

interactions

interactions

Related links

Does Unisom SLEEP AID interact with other drugs?

overdose

overdose

If someone has overdose and has severe symptoms such as fainting or trouble breathing, call 911.If not, contact a Poison Control Center immediately. US residents can call their local poison control center at 1-800-222-1222. Residents of Canada can call the provincial poison control center. Overdose symptoms may include: large pupils, hot flashes, fever, hallucinations, weakness, tremors (tremors), muscle twitching, loss of consciousness, convulsions. Children may first experience excitement, which may be followed by loss of coordination, drowsiness, loss of consciousness, convulsions.

Notes

Do not take several days before an allergy test, as this may affect test results.

Observe all routine medical and laboratory appointments.

Missed dose

Unsuitable.

Storage location

Refer to the storage information printed on the packaging. If you have any questions about storage, ask your pharmacist. Keep all food out of the reach of children and pets.

Do not flush medicines down the toilet or pour them down the drain unless directed to do so. Correctly discard this product when it has expired or is no longer needed. Check with your pharmacist or local waste disposal company. Last revised October 2018. Copyright (c) 2018 First Databank, Inc.

Photo Unisom (doxylamine) 25 mg tablets

Unisom (doxylamine) 25 mg tablets

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90,000 TOPCARE SLEEP AID – FDA PURPOSING INFORMATION, SIDE EFFECTS AND USAGE – MEDICINE

Generic name: doxylamine succinate Format: tablet Overview Side effects Dosage More than Doxylamine succinate 25 mg Night sleep helps reduce difficulty falling asleep Before using proconsu

Contents:

Generic name: doxylamine succinate
Form of issue: tablet

  • Review
  • Side effects
  • Dosage
  • More than

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Target

Night sleep

Uses

  • helps reduce difficulty falling asleep

Warnings

Consult a physician before use if you have

  • breathing problems such as asthma, emphysema or chronic bronchitis
  • glaucoma
  • urinary problems due to an enlarged prostate

Do not give

to children under 12

Consult your doctor or pharmacist before use if you are taking any other medications

When using this product

  • avoid alcoholic beverages
  • Take only at bedtime

Stop use and ask a doctor if

  • sleeplessness persists continuously for more than two weeks. Insomnia can be a sign of a serious underlying medical condition.

If pregnant or breastfeeding,

consult a physician before use.

Keep out of reach of children.

In case of overdose, seek medical advice or contact a Poison Control Center immediately.

Directions

  • adults and children from 12 years old: 1 tablet 30 minutes before bedtime; take once a day or as directed by a physician
  • children under 12 years of age: do not use

Additional Information

  • Store at 68 ° -77 ° F (20 ° -25 ° C)
  • Store in cardboard box until useon the end panel of the box

Inactive Ingredients

Dibasic Calcium Phosphate, FD&C blue no. 1 aluminum varnish, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

1-888-423-0139

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Fall asleep fast!

Safe

Sleeping pills

Doxylamine succinate tablets, 25 mg

Night sleep aid

Proven to be effective

Just one tablet per dose

Actual size

Compare Unabsom® Active Sleep3

Sleep pills carton

9046

Topcare Sleep Aid
Doxylamine Succinate Tablet

MEDICAL

)

Product Information
PRODUCT TYPE PRODUCT TYPE NDC: 36800-441
Administration Route ORAL DEA Schedule
Active Ingredient / Active Ingredient 9062 907454 silt Strength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 25 mg
Shape OVAL Size 10mm
Flavor Output Code L441
Contains
Contains 90662

904 62

90662

Product Code Package Description
1 NDC: 36800-441-64 2 BLISTERS (BLISTER PACK) in 1 CARTON
9457 9457 9457 9457 9457 9457 9457 9457 IN 1 BLISTER PACK

909946

Marketing Information
Marketing Category Application Number or Monograph Reference Marketing Start Date Marketing End Date
ANDA ANDA040167

.

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