The Truth About Over-the-Counter Sleep Aids

The Truth About Over-the-Counter Sleep Aids

Many Americans suffer from insomnia and commonly turn to prescription medications and over-the-counter sleeping aids for relief. About one in four Americans report taking some type of medication every year to help them sleep.

If you find yourself struggling after a few restless nights of sleep — perhaps trouble falling asleep, repeated awakenings, or waking up feeling tired, you may decide to try over-the-counter sleeping pills or consult your doctor about prescription sleep medications.

These days there is a wide variety of OTC medications filling pharmacy shelves that are advertised as sleep aids for those struggling to drift off at the end of a long and stressful day. However, the active ingredient in many of these drugs is one that will be familiar to people with allergies: antihistamines. The only difference is often marketing, according to sleep medicine experts.

Over-the-Counter vs. Prescription Drugs

A drug is a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Here are the main differences between OTC drugs and prescription drugs, according to the FDA.

Prescription drugs are:

  • Prescribed by a doctor
  • Bought at a pharmacy
  • Prescribed for and intended to be used by one person
  • Regulated by FDA through the New Drug Application (NDA) process. This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured.

OTC drugs are:

  • Drugs that do NOT require a doctor’s prescription
  • Bought off-the-shelf in stores
  • Regulated by FDA through OTC Drug monographs. OTC drug monographs are a kind of “recipe book” covering acceptable ingredients, doses, formulations, and labeling. Monographs will continually be updated adding additional ingredients and labeling as needed.

“The most common agent in over-the-counter sleeping aids is diphenhydramine, an antihistamine. It usually has a relaxing effect that makes you feel drowsy, but it may cause some grogginess the next day. Some popular OTC sleep aids also include pain relievers, which you may not need to take for insomnia or sleep problems. Although over-the-counter sleep medications are available without prescription and are generally considered safe, you should check with the pharmacist about any potential side effects or adverse drug interactions with other drugs you are taking for other health conditions like high blood pressure. You should be careful to take them only as directed especially if you’re taking other drugs that also contain antihistamines, like cold or allergy medications. Also, antihistamines can cause confusion in the elderly.”

If you’re having a sleep problem that lasts a few days, talk to your doctor about your concerns. You may have an underlying health problem, like a sleep disorder or depression.

Depending on the cause of your sleeping problem, he or she may prescribe a sleep medication, which is the most common treatment for insomnia.

Most Common OTC Sleeping Meds

The main non-prescription sleeping medications are Unisom, Benadryl, Sominex, Sleepinal, Nytol, Tylenol PM, Advil PM, Nyquil, Motrin, and other store-name brands.

Associated Risk

The idea that a pill can instantly solve your sleep problems is very appealing. Unfortunately, sleeping pills don’t cure the underlying cause of insomnia, and in fact can often make the problem worse in the long run. Concerns regarding over-the-counter (OTC) and prescription sleep aids include:

  • Side Effects – drowsiness, confusion, forgetfulness can all result from sleep aids.
  • Drug Tolerance – over time you may build up a tolerance to sleep aids, causing you to need to take more to feel their effects, which can lead to addiction or overdose of these “safe” OTC drugs. Any drug in un-recommended quantities or dosages can be risky, even deadly.
  • Drug Dependence – you may become reliant on sleeping pills, making you unable to sleep or have worse sleep when not taking them.
  • Withdrawal Symptoms – abrupt termination of sleeping pill ingestion may cause withdrawal symptoms like nausea, sweating and shaking.
  • Drug Interactions – mixing with other prescription or non-prescription drugs.
  • Rebound Insomnia – taking pills can help insomnia, but if you stop taking them, it could make the insomnia worse than it was before ever taking pills to address it.
  • Masking an underlying problem – i.e. underlying medical, mental or even sleep disorder.
  • Allergic Reactions – Other rare but potential side effects of sedative-hypnotic drugs are a severe allergic reaction (anaphylaxis) and severe facial swelling (angioedema), which can occur as early as the first time the product is taken. It the allergic reaction is severe enough, it can a patient’s ability to breathe and can affect other body systems as well, and can even be fatal at times.

Antihistamines can make people feel sleepy, groggy and fuzzy and since a large number of OTC sleep aids include diphenhydramine, (an active ingredient in Zzzquil and Benadryl), it is not surprising these medications advertise themselves as a helpful solution for people who have trouble falling asleep.

“Little long-term research exists on the risks associated with continuous use of OTC sleep aids, but the main concern among physicians and sleep specialists is the potential for dangerous drug interactions with other medications. But for a person in good health who does not take other prescription medications, this risk is much lower. Instead, the danger for this group is that they’ll experience drowsiness that lasts longer than the amount of time they intended to sleep.”

Keep in mind as well, that the body builds tolerance to sedatives rather quickly. This means that the longer you rake antihistamines, the less likely you are to feel the sleep side effects because your tolerance to the sedative effects of antihistamines has increased. This doesn’t mean you should take more to feel the effects, in fact that could make the situation worse and lead to an overdose of the OTC medication which can be deadly.


  1. The Truth About Over-The-Counter Sleep Aids.
  2. Living With Insomnia: Get a Good Night’s Sleep.
  3. Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and Answers.
  4. Sleep Aids: Understand over-the-counter options
  5. Understanding the Side Effects of Sleeping Pills.
  6. Over-the-counter Sleep Aids: 29 Nasty, Dangerous Side Effects.
  7. Sleeping Pills & Natural Sleep Aids.
  8. Side Effects of Sleep Drugs.
  9. Over-the-counter sleep aids linked to dementia.
  10. Is Diphenhydramine dangerous if taken nightly as a sleep aid?

About SignatureMD

SignatureMD is one of the nation’s largest firms providing initial conversion and ongoing support services to concierge medicine physicians. SignatureMD currently partners with over 200 affiliated primary care physicians and specialists across 35 states, and its network is rapidly expanding.