OTC sleep aids: You snooze, you win

December 11, 2009

Nearly a third of all Americans have trouble getting a good night's sleep. Although customers seeking OTC help this year will have to rely on the old stand-by, antihistamines, a few new products are available.

Key Points

Nearly a third of all Americans are tossing and turning, unable to get a good night's sleep because they're worrying about the economy, their jobs, or their money, according to a National Sleep Foundation poll announced earlier this year. Added to those with financial woes are increasing numbers of people over age 60, who typically have a harder time falling asleep and awaken more often. Small wonder that Americans spent more than $600 million on OTC sleep aids in 2008 (Time, June 1, 2009).

Customers seeking OTC help this year will have to rely mainly on antihistamines. Most of these products contain diphenhydramine; some, doxylamine. However, a few manufacturers have recently expanded their product lines or ventured into the sleep arena for the first time.

One newcomer is Help Remedies, whose goal is to offer the "best available solution in the simplest form." For example, the "Help: I Can't Sleep" package contains 16 caplets of 25mg diphenhydramine with "the fewest possible fillers, coatings or dyes." Help's outer packaging for all six product lines is made of two compostable materials: molded paper pulp and a bioplastic made from corn resin. For the sake of simplicity, all Help products are priced at $3.99. In addition, each package is white, simply labeled with its self-descriptive name, and color-coded according to the problem it addresses.

Breathe Right Kids is designed to fit small noses. Product literature refers to a study in healthy children showing that these nasal strips help children breathe better during sleep by improving their airflow when they are lying down. The nasal strips are drugfree and consist of a flexible springlike band that goes across the bridge of the nose. They are well tolerated by children and can be worn overnight.

In May, McNeil Consumer Healthcare introduced the Tylenol PM Sleep Track iPhone application , which lets consumers track their sleep hours and moods, see their sleep history over time, and gets tips on how to improve their sleep habits. A company spokesman adds, "For pain and sleeplessness, Tylenol PM is now the No. 1 doctor-recommended over-the-counter sleep medication."

A year ago, Perrigo Co. received FDA approval for its own OTC ibuprofen-based pain reliever and sleep aid (diphenhydramine); it began shipping private-label tablets to retailers in February. The generic "compares to Advil PM," says a company spokesperson. "It's available to all major retailers under their store-brand label." Retailers too small to have their own store-brand label can obtain the product through the GoodSense label (GoodSense Ibuprofen PM). He adds that people with back problems who have trouble sleeping find it particularly helpful.

Consumers are showing increasing interest in "natural" sleep products. Dietary supplements and herbal compounds most often promoted as sleep aids include valerian, lavender, rose hips, and melatonin, among others. Such products may interfere with common drugs and do have potential for side effects. According to the Mayo Clinic, people taking melatonin have reported daytime drowsiness, headaches, and dizziness. Valerian side effects may include headache, excitability or uneasiness, and heart disturbances. Consumers, however, seek them out.

From Innovative Beverage Group comes a unique peripheral addition to the natural sleep-aid category: drank, dubbed "the world's first extreme relaxation beverage." A lightly carbonated grape-flavored beverage, drank contains a combination of melatonin, valerian root, and rose hips, said to calm and relax the mind and body. A company spokesman says, "The drink is not all natural, but those three ingredients are all natural. It is a soda, but with those ingredients."

Dana K. Cassell, a frequent contributor to Drug Topics, lives in North Stratford, New Hampshire.