Regulations last checked for updates: Feb 12, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 338.3 - Definition.

As used in this part:

Nighttime sleep-aid. A drug that is useful for the relief of occasional sleeplessness by individuals who have difficulty falling asleep.

source: 54 FR 6826, Feb. 14, 1989, unless otherwise noted.
cite as: 21 CFR 338.3