Somnote (Chloral Hydrate) - Indications and Dosage

INDICATIONS AND USAGE

Chloral Hydrate is used primarily as a hypnotic in the management of simple insomnia. It is effective as a hypnotic only for short term use. Chloral Hydrate has been found to lose much of its effectiveness for both inducing and maintaining sleep by the end of a 2 week period of administration. Chloral Hydrate may also be used as a routine sedative. It has been used preoperatively or prior to electroencephalographic evaluation to allay anxiety and produce sedation and/or sleep. Chloral Hydrate, alone or in conjunction with Paraldehyde, may be effective in suppressing and/or reducing alcohol withdrawal symptoms. It may also be effective in reducing anxiety associated with withdrawal of other drugs such as narcotics or barbiturates.

DOSAGE AND ADMINISTRATION

The usual hypnotic dose of Chloral Hydrate for adults is 500 mg to 1 gram 15 to 30 minutes before retiring. The usual sedative dosage is 250 mg 3 times daily after meals. When Choral Hydrate is administered in the management of alcohol withdrawal symptoms, the usual dosage is 500 mg to 1 gram repeated at 6-hour intervals if needed. Generally, single doses or daily dosage for adults should not exceed 2 grams.

HOW SUPPLIED

Somnote^® Capsules are supplied as gray, oval-shaped softgel capsules, imprinted "B-080". Available in unit dose packaging 50 capsules (5 — 10), NDC 51991-080-51, and bottles containing 50 capsules, NDC 51991-080-52.

Store at 25°C (77°F); excursions permitted to 15°-30°C(59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

WARNING: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Manufactured by:
G. Pohl Boskamp GmbH & Co.
Hohenlockstedt, Germany

Distributed By:
Breckenridge Pharmaceutical, Inc.
Boca Raton, FL 33487

REV. 5/09
Rx Only