chloral hydrate (Rx)

Brand and Other Names:Somnote
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Dosing & Uses

AdultPediatric

Dosage Forms & 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

Dosage Forms & 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  

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Interactions

Interaction Checker

and chloral hydrate

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            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

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            Pregnancy & 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.

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            Pharmacology

            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

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.