Dosing and uses of Somnote (chloral hydrate)
Adult dosage forms and strengths
capsule: Schedule IV
- 500mg
syrup: Schedule IV
- 500mg/5mL
Insomnia
Indicated for use as hypnotic for simple insomnia; rarely used for this indication
500 mg to 1 g PO 15-30 minutes before bedtime; for short-term use only (ie, up to 2 weeks); not to exceed 2 g/24hr
Sedative/Anxiety
250 mg PO PC q8hr; not to exceed 2 g/day
Renal Impairment
Contraindicated in moderate-severe renal impairment
Hepatic Impairment
Contraindicated in moderate-severe hepatic impairment
Administration
Upon discontinuation withdraw gradually over 2 weeks if patient maintained on high doses for prolong periods of time; abrupt discontinuation may result in delirium
Pediatric dosage forms and strengths
capsule: Schedule IV
- 500mg
syrup: Schedule IV
- 500mg/5mL
Sedation for Procedures (Off-label)
50-75 mg/kg PO 30-60 min before procedure; may repeat in 30 min if necessary
Not to exceed 120 mg/kg or 1 g/dose in infants or 2 g/dose in children
Sedation/Anxiety (Off-label)
May be used prior to procedure or EEG evaluation
25-50 mg/kg/day PO divided q6-8hr; not to exceed 500 mg/dose
Interactions
Frequency not defined
Common
- Hangover
- Sedation
- Diarrhea
- GI upset
- Nausea
- Vomiting
Less Common
- Angioedema
- Somnambulism
- Disorientation
- Paranoia
- Rash
- Erythema multiforme
- Leukopenia
- Eosinophilia
Rare
- Ataxia
- Confusion
- Delirium
- Dizziness
- Headache
- Nightmares
- Vertigo
- Ketonuria
Warnings
Contraindications
Hypersensitivity/idiosyncrasy to chloral derivatives
Marked renal, hepatic impairment; severe cardiac disease; gastritis & ulcers
Cautions
Potential toxic dose <6 years old: 50 mg/kg
Use with caution in porphyria
Use caution in long term care patients, elderly, and neonates
Use not recommended for >2 weeks
Abrupt discontinuation may cause withdrawal symptoms
Pregnancy and lactation
Pregnancy category: C
Lactation: small amount secreted into breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Somnote (chloral hydrate)
Mechanism of action
Unknown; produces central nervous system depression
Absorption
Onset: 30-60 min
Duration: 4-8 hr
Peak Plasma Levels: 7-10 mcg/mL
Metabolism
Metabolized by alcohol dehydrogenase, glucuronidation
Metabolites: trichloroethanoL
Elimination
Half-Life: 8-11 hr (active metabolite)
Excretion: Mostly in urine; some feces
