Adult Dosing

Hypnotic

• 500-1000 mg PO 15-30 mins qhs

Preoperative sedation

• 500-1000 mg PO 30 mins prior to surgery

Sedation

• 250 mg PO tid
• Single dose/daily dose should not >2 g

Alcohol withdrawal symptoms

• 500-1000 mg PO q6 hrs PRN

Pediatric Dosing

Pre EEG sedation

• Child >1 month: 20-25 mg/kg PO 30–60 mins prior

Sedation prior to dental/medical procedures

• Child >1 month: 50-75 mg/kg PO 30–60 mins prior; may repeat within 30 min PRN
• Max: 1 g total single dose (for infants); 2 g total single dose (for children)

Hypnotic

• 50 mg/kg PO; max. 2 g/day PO

Sedation/anxiety

• Child >1 month: 25-50 mg/kg/day PO divided q6–8 hrs; max. 500 mg/dose PO

[Outline]

• Adult Dosing
• Pediatric Dosing

• Short-term sedative and hypnotic
• Sedation or reduction of anxiety preoperatively (anesthetic adjunct) or prior to diagnostic procedures
• Management of alcohol withdrawal symptoms

• Hypersensitivity to any of the ingredients of the product
• Severe cardiac disease
• Severe renal impairment (CrCl <50 mL/min)
• Marked hepatic impairment
• Coma or pre-existing CNS depression
• Uncontrolled severe pain
• Esophagitis, gastritis, or ulcer disease
• Impaired respiratory function
• Sleep apnea

• N/A

Renal Dose Adjustment

• Renal impairment: Contraindicated

Hepatic Dose Adjustment

• Hepatic impairment: Contraindicated

See Supplemental Patient Information

• Therapy may cause anaphylaxis (severe allergic reaction) or angioedema with the first dose
• Complex sleep-related behaviors including sleep-driving, making phone calls, and preparing and eating food have also been reported
• Effectiveness of warfarin may decrease if used concomitantly; the prothrombin time of patients on anticoagulant therapy must be followed continually
• Cautiously administer to patients who are mentally depressed, have suicidal tendencies or a history of drug abuse, or whose history indicates they may increase dosage on their own initiative
• Do not use large doses in patients with severe cardiac disease. Chronic use may cause gastritis, skin eruptions, or parenchymatous renal damage
• To avoid precipitation of withdrawal symptoms following chronic administration, chloral hydrate should be withdrawn slowly
• Chloral Hydrate has been reported to precipitate attacks of acute intermittent porphyria and should be used with caution in susceptible patients

Caution: Use cautiously in

• Mental depression
• History of drug abuse
• Neonates
• Porphyria
• CNS depressant use

Supplemental Patient Information

• Therapy is not recommended during pregnancy or for those patients who are planning to become pregnant or who a are currently breast-feeding. Contact physician or health-care provider before use.

Pregnancy Category:C

Breastfeeding: Short-term or occasional use of chloral hydrate during breastfeeding is unlikely to adversely affect the breastfed infant, especially if the infant is older than 2 months. Other sedative-hypnotics are preferred for long-term use during breastfeeding, especially while nursing a neonate or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 21 June 2011). Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• CNS: Hangover, dizziness
• PSYCHIATRIC: Somnambulistic reaction, disorientation, incoherence
• GI: Nausea, vomiting, diarrhea
• DERM: Erythematous rash, urticaria, angioedema, purpura, eczema, bullous lesions, erythema multiforme
• MUSC: Ataxia
• MISC: Fever

• Sedative/hypnotic; converted to trichloroethanol which is the active drug. Has generalized CNS depressant properties
• Metabolized by liver, plasma, kidney
• Excreted in urine
• Half-life:
• Chloral hydrate: 1 hr (infants)
• Trichloroethanol: 8.5-66 hrs (neonates); 10 hrs (children); 8-11 hrs (adults)

US Trade Name(s)

• Somnote

US Availability

chloral hydrate (generic)

• SYRUP: 500 mg/5 mL

Somnote

• CAPS: 500 mg

Canadian Trade Name(s)

• Only generic available

Canadian Availability

chloral hydrate (generic)

• CAPS: 500 mg
• SYRUP: 100 mg/mL

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Only generic available

Australian Availability

chloral hydrate (generic)

• SYRUP: 100 mg/mL

[Outline]

Psychiatric

Sedative Hypnotics

Analgesics

Antimigraine Agents

Other

Pricing data from www.DrugStore.com in U.S.A.

• Somnote 500 MG CAPS [Box] (BRECKENRIDGE)
  50 mg = $79.99
  150 mg = $229.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Somnote (Chloral Hydrate 500 mg)

Ingredient(s): N/A

Imprint: B080

Color(s): Gray

Shape: Oval

Size (mm): 15.00

Score: 1

Inactive Ingredient(s): polyethylene glycol 400 / gelatin / glycerin / sorbitol / mannitol / titanium dioxide / ferric oxide red

Drug Label Author:
Breckenridge Pharmaceutical, Inc.

DEA Schedule:
CIV