Aleve PM Review

Quick verdict: Aleve PM is an over-the-counter medication for occasional sleeplessness associated with minor aches and pains. It combines a pain reliever with a sedating antihistamine, but it is not intended for insomnia unrelated to pain or for regular, long-term use.

The combination may be convenient when both pain and sleeplessness are present. Its main drawback is that it exposes the user to the stomach, bleeding, cardiovascular, and kidney risks of an NSAID as well as the drowsiness and other effects of diphenhydramine.

What Is Aleve PM?

Aleve PM is an FDA-approved fixed-combination drug containing naproxen sodium and diphenhydramine hydrochloride. The FDA approved the combination under New Drug Application 205352 on January 16, 2014.

Approval supports its labeled use; it does not mean Aleve PM is appropriate for every person or every sleep problem. In particular, it should not be used simply as a sleep aid when pain is not present, because doing so adds unnecessary exposure to naproxen.

Ingredients and How They Work

1. Naproxen sodium, 220 mg: A nonsteroidal anti-inflammatory drug, or NSAID. It reduces the production of substances involved in pain and inflammation.
2. Diphenhydramine HCl, 25 mg: A sedating antihistamine used here as a nighttime sleep aid. It can cause substantial drowsiness and may affect alertness the following day.

The label also lists inactive ingredients including carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, talc, titanium dioxide, and FD&C Blue No. 2 aluminum lake. Formulations can change, so check the package if you have an allergy or sensitivity.

What Aleve PM Is—and Is Not—Designed to Treat

Aleve PM is designed for people who are temporarily unable to sleep because of minor pain, such as a headache, backache, muscular ache, minor arthritis pain, toothache, menstrual cramps, or discomfort from a cold.

It is not intended to treat chronic insomnia, anxiety-related sleeplessness, or other sleep difficulties when pain is absent. Although diphenhydramine is an antihistamine, Aleve PM is also not labeled as an allergy treatment.

How to Take Aleve PM

According to the current Drug Facts label, adults and children 12 years and older should take two caplets at bedtime. Do not take more than two caplets in 24 hours.

• Follow the package directions rather than increasing the dose if it does not work as expected.
• Take it with food or milk if stomach upset occurs.
• Do not give it to a child under 12 unless directed by a doctor.
• Seek medical advice if pain lasts more than 10 days or sleeplessness continues for more than two weeks.

Persistent pain or insomnia can have many causes. It should be evaluated rather than repeatedly managed with a combination nighttime medication.

Does Aleve PM Work?

Naproxen is an established NSAID pain reliever, while diphenhydramine commonly causes sedation. Combining them can therefore address both minor pain and short-term difficulty sleeping because of that pain.

The dose and finished combination have FDA approval for this specific labeled purpose. However, that does not establish that Aleve PM is better than every other nighttime pain reliever, and it has not been established as a treatment for chronic insomnia.

Diphenhydramine-related sedation should not be confused with consistently restorative or higher-quality sleep. Some people may also experience next-day grogginess, and the sedating effect may become less useful with repeated use.

Common Side Effects

Possible side effects come from both active ingredients. They can include:

• Drowsiness or next-day grogginess
• Dizziness
• Dry mouth, nose, or throat
• Blurred vision
• Constipation
• Upset stomach or heartburn

Do not drive, operate machinery, or perform tasks requiring full alertness until you know how the medication affects you.

Important Safety Warnings

Stomach and intestinal bleeding

Naproxen can cause stomach or intestinal bleeding, sometimes without much warning. Risk is higher in adults over 60, people with a history of ulcers or bleeding, and those taking blood thinners, corticosteroids, aspirin, or other NSAIDs. Drinking three or more alcoholic beverages a day also increases the risk.

Heart and circulation risks

NSAIDs can increase the risk of heart attack or stroke. The risk may be greater in people with cardiovascular disease or risk factors, and it can increase when an NSAID is taken at higher doses or for longer than directed. Aleve PM must not be used immediately before or after coronary artery bypass graft surgery.

Kidney problems

Naproxen can affect kidney function, particularly in older adults and people with kidney disease, heart failure, dehydration, or certain medication combinations.

Allergic reactions

Do not use Aleve PM if you have previously had an allergic reaction to naproxen, diphenhydramine, aspirin, or another pain reliever. Get urgent help for facial swelling, wheezing, hives, shock, or a blistering skin reaction.

Excessive sedation and confusion

Diphenhydramine can impair coordination and thinking. Older adults may be more susceptible to next-day grogginess, memory problems, confusion, and falls.

When to Get Urgent Medical Help

Stop taking the medication and seek prompt medical attention for warning signs such as:

• Vomiting blood or material resembling coffee grounds
• Black or bloody stools
• Feeling faint with stomach pain
• Chest pain, weakness on one side, or slurred speech
• Trouble breathing or swelling of the face or throat
• Severe confusion, extreme drowsiness, or suspected overdose
• Little or no urine, especially with swelling or shortness of breath

Who Should Ask a Clinician or Pharmacist First?

Professional guidance is particularly important if you are 65 or older or have:

• A history of stomach ulcers or gastrointestinal bleeding
• Heart disease, heart failure, high blood pressure, or a previous stroke
• Kidney or liver disease
• Asthma or a previous reaction to aspirin or another NSAID
• Glaucoma
• An enlarged prostate, urinary retention, or difficulty urinating
• A chronic breathing condition such as emphysema or chronic bronchitis

People who are pregnant or breastfeeding should consult a healthcare professional. Naproxen is especially concerning from 20 weeks of pregnancy onward and should not be used at that stage unless specifically directed by a clinician.

Drug and Alcohol Interactions

Do not combine Aleve PM with another product containing naproxen or diphenhydramine. Check nighttime cold, allergy, and pain medicines carefully because they may contain one of the same ingredients.

Ask a pharmacist or clinician before combining it with:

• Ibuprofen, aspirin-containing pain relievers, or other NSAIDs
• Blood thinners or antiplatelet medicines
• Corticosteroids
• Sedatives, tranquilizers, sleep medicines, or opioid pain medicines
• Antidepressants or other medicines that can increase bleeding or drowsiness
• Diuretics and some medicines for blood pressure or heart disease

Avoid alcohol. It can worsen drowsiness and increase the chance of stomach bleeding.

Aleve PM Compared With Regular Aleve

Regular Aleve contains naproxen sodium but no sleep aid. It may be the more relevant product when pain is present but sedation is not needed.

Aleve PM contains both naproxen and diphenhydramine. It is intended only when minor pain is causing occasional sleeplessness.

Other nighttime pain products may use acetaminophen rather than an NSAID. That avoids some NSAID-related risks but introduces different concerns, including liver injury if too much acetaminophen is taken. Product labels should be compared carefully to prevent duplicate ingredients.

Pros and Cons

Pros

• Combines pain relief and a nighttime sleep aid in one product
• Clearly labeled active-ingredient amounts and dosing
• Available without a prescription
• FDA-approved for occasional sleeplessness associated with minor pain

Cons

• Not appropriate for insomnia without pain
• Can cause next-day drowsiness, dizziness, and impaired coordination
• Carries NSAID-related bleeding, cardiovascular, and kidney risks
• May be unsuitable for many older adults or people taking other medicines
• Not intended as a regular or long-term sleep treatment

Company Contact Information

DailyMed identifies Bayer HealthCare LLC as the packager of Aleve PM. Bayer Corporation lists its U.S. address as 100 Bayer Boulevard, Whippany, NJ 07981.

Phone: 862-404-3000

Website: aleve.com

The official Aleve website also provides an online product contact form. No verified product-specific email address was available.

Final Verdict

Aleve PM has a narrowly defined role: temporary relief when minor pain is keeping someone awake. Its two active ingredients are established medicines, and the finished combination is FDA-approved for that purpose.

It is a poor fit for sleeplessness without pain because the naproxen provides no relevant benefit while still carrying NSAID risks. Older adults and people with ulcers, heart or kidney disease, urinary problems, glaucoma, or multiple medications should be particularly cautious.

This information is educational and cannot diagnose a condition or determine whether Aleve PM is safe for a particular person. A pharmacist or clinician can review individual health conditions and medication interactions.

Frequently Asked Questions

Can Aleve PM be taken every night?

It is labeled for occasional use, not as a nightly treatment for chronic insomnia. Seek medical advice if sleeplessness continues for more than two weeks or pain lasts more than 10 days.

Can Aleve PM be combined with regular Aleve?

No, not unless a clinician specifically directs it. Both contain naproxen, and combining them can exceed the recommended amount and increase the risk of bleeding, kidney problems, and other adverse effects.

Is Aleve PM simply a sleep aid?

No. It also contains an NSAID pain reliever. It is intended for sleeplessness caused by minor pain, not for insomnia when pain is absent.

How many caplets can be taken?

The label directs adults and children 12 years and older to take two caplets at bedtime, with no more than two caplets in 24 hours.

Can Aleve PM cause next-day drowsiness?

Yes. Diphenhydramine can cause grogginess, slower reaction time, dizziness, or impaired coordination the following day. This may be more pronounced in older adults.

Can Aleve PM be taken with alcohol?

Alcohol should be avoided. It can increase sedation and raise the risk of stomach bleeding associated with naproxen.

Sources

• DailyMed: Aleve PM Drug Facts
• Aleve PM Frequently Asked Questions
• FDA postmarket safety evaluation
• MedlinePlus: Medicines for sleep

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