Generic Name and Formulations:
Zaleplon 5mg, 10mg; caps; contains tartrazine.
Indications for SONATA:
Short-term treatment of insomnia.
Usually 10mg at bedtime (at least 4hrs before becoming active again); max 20mg. Mild-to-moderate hepatic impairment, elderly, debilitated, concomitant cimetidine, or low weight patients: 5mg; max 10mg. Max 1month/℞. Effect delayed if taken with high-fat/heavy meals.
Severe hepatic impairment: not recommended. Compromised respiratory function, mild-to-moderate hepatic impairment, debilitated: monitor closely. Depression. Behavioral changes. Suicidal tendencies. Drug or alcohol abuse. Conditions that affect metabolism or hemodynamic response. Write ℞ for smallest practical amount. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C), nursing mothers: not recommended.
Potentiates CNS depression with alcohol, other CNS depressants. Efficacy may be compromised by drug(s) that induce CYP3A4. May be potentiated by drugs that inhibit aldehyde oxidase (eg, cimetidine, possibly diphenhydramine). May be antagonized by promethazine.
CNS effects, complex sleep-related behaviors (eg, sleep-driving), GI upset, abdominal pain, migraine; anaphylaxis, angioedema, others (see full labeling).
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