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zaleplon (Rx)Brand and Other Names:Sonata

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule: Schedule IV

  • 5mg
  • 10mg
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Insomnia (Short-term Use)

10-20 mg PO qHS, range 5-20 mg/day

Renal Impairment

Mild to moderate impairmet: No dose adjustment necessary

Severe impairment: Not studied

Hepatic Impairment

Mild to moderate impairment: 5 mg at bedtime

Severe impairment: Not recommended

Not recommended

5 mg PO qHS; not to exceed 10 mg/day

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Interactions

Interaction Checker

zaleplon and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (38%)

            1-10%

            Dizziness (7-9%)

            Nausea (6-8%)

            Abdominal pain (6%)

            Weakness (5-7%)

            Dysmenorrhea (3-4%)

            Eye pain (3-4%)

            Amnesia (2-4%)

            Parasthesia (3%)

            Tremor (2%)

            <1%

            Fever

            Photosensitivity

            Anorexia

            Colitis

            Periphipheral edema

            Amnesia

            Anxiety

            Depersonalization

            Hallucination

            Hypesthesia

            Vertigo

            Epistaxis

            Abnl vision

            Ear pain

            Hyperacusis

            Parosmia

            Postmarketing Reports

            Anaphylactic/anaphylactoid reactions, including severe reactions

            Nightmares

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            Warnings

            Contraindications

            Hypersensitivity

            Severe hepatic impairment

            Cautions

            May impair ability to perform hazardous tasks

            Depression, hepatic impairment

            Amnesia may occur

            Sleep related activities may occur

            Use caution in patients respiratory diseases or patients experiencing clinical depression (condition may worsen)

            Effects of other CNS depressants being taken concurrently may be potentiated

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: small amount secreted in breast milk, not recommended

            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

            Pyrazolopyrimidine; GABA-BZD receptor complex agonist

            Pharmacokinetics

            Half-life elimination: 1 hr

            Duration: Shorter than  zolpidem

            Peak Plasma Time: 1 hr

            Bioavailability: 30% (undergoes extensive presystemic metabolism)

            Protein Bound: 45-75%

            Vd: 1.4 L/kg

            Metabolism: mostly by aldehyde oxidase; some by CYP3A4

            Metabolites: Inactive

            Total Body Clearance: 3 L/hr/kg

            Excretion: urine 70%; feces 17%

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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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