FDA Advice on Tylenol PM During Pregnancy

Pregnant woman sleeping comfortably

If you are having difficulty sleeping, you may be wondering if Tylenol PM and pregnancy make a safe combination for your baby.

Food and Drug Administration Recommendations

Tylenol PM is the combination of the pain reliever acetaminophen and the sleep aid diphenhydramine. The FDA places both acetaminophen and diphenhydramine in drug category B because they have shown no adverse effect in animal studies, but no controlled studies have been done on pregnant women. FDA Drug Category B indicates that animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women or animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Many women prefer to avoid all medications while they are pregnant no matter how the FDA classifies them. But if you are sick or are having discomfort, your doctor may recommend regular strength Tylenol or Tylenol PM.

This is what the Tylenol website said about Tylenol products in general and pregnancy: "If you are pregnant or breast feeding, seek the advice of your healthcare professional before using TYLENOL® or any other medication."

Natural Sleep Strategies

Even though the FDA has placed Tylenol PM in Category B, you should always try natural remedies to help you sleep before you take medications.

Here are some ideas to help you fall asleep and stay asleep:

  • Avoid drinking caffeine
  • Drink liquids frequently during the day, but slow down and drink less liquid 2 hours before bedtime so you won't have to get up to use the restroom
  • Ask a loved one for a massage
  • Sleep with extra pillows between your knees, feet, behind your back, and in front--consider buying a maternity pillow
  • Eat plenty of protein
  • Take your prenatal vitamins several hours before bedtime
  • Take a nap during the day if that helps make up for lack of sleep at night
  • Get plenty of physical exercise during the day
  • Take a yoga class that stresses breathing and relaxation
  • Get educated about pregnancy and childbirth to allay your fears
  • Ask friends and family for help with housework (or your other children) if you are feeling overwhelmed and stressed out

Consult Your Physician

Your doctor's advice is of utmost importance when you are having difficulty sleeping. Consult your physician to get the most recent information on Tylenol PM and pregnancy for you and your baby.

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FDA Advice on Tylenol PM During Pregnancy