Stronger warnings for the labeling for 13 sedative-hypnotics were recently requested by the FDA.
Stronger warnings for the labeling for 13 sedative-hypnotics were recently requested by the FDA. Severe allergic reactions and sleep-related behaviors, including "sleep driving," are among the serious risks that can occur following ingestion of the drugs. Sleep driving is the name given to driving while not fully awake without memory of the event. In addition to the revisions, the agency has also requested that manufacturers send letters to providers alerting them to the labeling changes and develop Patient Medication Guides for the products to inform consumers of the potential risks. The FDA also sent a letter on March 5 to the manufacturer of ramelteon (Rozerem, Takeda) asking it to cease distribution of promotional materials that feature school-age children, calling a TV ad ?especially concerning? since the drug is not approved for pediatric use.