Nighttime Sleep Aid
The FDA has an OTC monograph, M010, that outlines the regulations for over-the-counter nighttime sleep aids. This ensures these medications are safe and effective for occasional sleep problems. These sleep aids are typically meant for adults who have difficulty falling asleep, not staying asleep. The only approved active ingredients are diphenhydramine hydrochloride and citrate, which cause drowsiness. These medications come with labeling requirements to inform consumers about proper use and potential side effects.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Diphenhydramine hydrochloride | M010.10 (Part 338) |
| Diphenhydramine citrate | M010.10 (Part 338) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
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