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warnings
WARNINGS Anaphylaxis (severe allergic reaction) and angioedema (severe facial swelling), which can occur as early as the first time the product is taken. Complex sleep-related behaviors which may include sleep-driving, making phone calls, and preparing and eating food (while asleep). Chloral Hydrate may be habit-forming. Chloral Hydrate may increase the rate of metabolism of concomitantly administered Warfarin anticoagulants, thus reducing their effectiveness. Upon withdrawal of Chloral Hydrate, the rate of metabolism of the anticoagulant drug will decrease and its plasma level will rise, with the possibility of a sudden increase of anticoagulant effects (i.e., development of bleeding tendency and hemorrhage). The prothrombin time of patients on anticoagulant therapy normally must be followed continually; however, when Chloral Hydrate is added to or subtracted from the therapeutic regimen, or when changes in dosage of Chloral Hydrate are contemplated, the effect of the sedative on prothrombin time deserves special attention. Use of this product is not recommended if you are pregnant, or planning to become pregnant or are currently breast-feeding. Please contact your physician, or health-care provider before using or continuing use. (see PRECAUTIONS, Pregnancy )
ADVERSE REACTIONS Gastric irritation manifested by nausea, vomiting, and diarrhea is the most frequent side effect of oral Chloral Hydrate administration. This effect may be minimized by administering the capsule with a full glass of water or other liquid. There is no evidence in the published literature to support the claim that the complex, chloral betaine, causes less gastric irritation than does Chloral Hydrate. Residual sedation or "hangover" occurs infrequently following usual hypnotic doses. Cutaneous reactions to Chloral Hydrate are not common but have included scarlatiniform or erythematous rash, urticaria, angioedema, purpura, eczema, bullous lesions, and erythema multiforme. Sometimes these cutaneous reactions have been accompanied by fever; ataxia and dizziness have also occurred. Rarely, a somnambulistic reaction characterized by disorientation and incoherence has been reported.