Monograph Details
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Central Nervous System
> Insomnia
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SONATA |
| Manufacturer |
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King Pharmaceuticals, Inc. |
| Legal Classification |
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CIV |
| Pharmacological Class |
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Pyrazolopyrimidine hypnotic. |
| Generic Name |
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Zaleplon 5mg, 10mg; caps; contains tartrazine. |
| Indications |
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Short-term treatment of insomnia. |
| Children |
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Not recommended. |
| Adults |
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Usually 10mg at bedtime (at least 4 hours before becoming active again); max 20mg. Mild-to-moderate hepatic impairment, elderly, debilitated, concomitant cimetidine, or low weight patients: 5mg; max 10mg. Max 1month/Rx. Effect delayed if taken with high-fat/heavy meals. |
| Precautions |
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Severe hepatic impairment: not recommended. Compromised respiratory function, mild-to-moderate hepatic impairment, debilitated: monitor closely. Depression. Behavioral changes. Drug or alcohol abuse. Conditions that affect metabolism or hemodynamic response. Write Rx for smallest practical amount. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C), nursing mothers: not recommended. |
| Interactions |
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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). May be antagonized by promethazine. |
| Adverse Reactions |
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CNS effects, complex sleep-related behaviors (eg, sleep-driving), GI upset, abdominal pain; anaphylaxis, angioedema, others (see literature). |
| How Supplied |
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Caps—100 |
| Additional Resources |
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• Related Prescribing Note |
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