WASHINGTON -- The Food and Drug Administration Wednesday approved the notorious date-rape drug, GHB for treating a small population of patients with narcolepsy who experience episodes of cataplexy, a condition characterized by weak or paralyzed muscles.

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Because of safety concerns associated with the use of the drug, the distribution of GHB, to be sold under the brand name Xyrem (sodium oxybate or gamma hydroxybutyrate), will be dispensed under some of the tightest restrictions ever imposed on a medication, according to an FDA news release.

In the early 1990s GHB, which was originally used as an anesthetic, was marketed as a dietary supplement, for enhancing athletic performance and sexual activity, and for inducing sleep.

GHB is probably best known for being abused as a recreational drug and for use in date rape. Colorless and odorless, it made headlines when people slipped it into drinks, knocking out victims who often had no memory of what happened.

As the result of a number of serious adverse events, including death, FDA officials intervened to prohibit marketing of GHB.

Xyrem, manufactured by Orphan Medical Inc., was designated Wednesday as a Schedule III Controlled Substance for medical use, meaning it cannot be sold, distributed, or provided to anyone other than for its prescribed use. Illicit use of Xyrem will be subject to the most restrictive schedule of the Controlled Substances Act, the FDA said in its news release.

Narcolepsy patients suddenly fall asleep from a few seconds to an hour. GHB doesn't treat that symptom. But approximately 20,000 to 50,000 narcolepsy patients also suffer from cataplexy, a muscle-weakness complication that can cause people to collapse without warning.