Monograph Details
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Central Nervous System
> Insomnia
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RESTORIL |
| Manufacturer |
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Mallinckrodt, Inc. |
| Legal Classification |
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CIV |
| Pharmacological Class |
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Benzodiazepine. |
| Generic Name |
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Temazepam 7.5mg, 15mg, 22.5mg, 30mg; caps. |
| Indications |
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Short-term (7–10 days) treatment of insomnia. |
| Children |
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<18yrs: not recommended. |
| Adults |
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7.5mg–30mg at bedtime. Elderly or debilitated: 7.5mg. Max 1 month/Rx. |
| Contraindications |
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Pregnancy (Cat.X). |
| Precautions |
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Drug or alcohol abuse. Suicidal tendencies. Depression. Renal, hepatic, or respiratory impairment. Reevaluate if used ≥2–3 wks. Sleep disturbances after stopping drug. Avoid abrupt cessation after prolonged use. Nursing mothers. |
| Interactions |
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Potentiates CNS depression with alcohol, other CNS depressants. |
| Adverse Reactions |
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CNS depression, complex sleep-related behaviors (eg, sleep-driving), lethargy, confusion, weakness, ataxia, paradoxical excitement, euphoria; anaphylaxis, angioedema. |
| How Supplied |
7.5mg, 22.5mg—30, 100
15mg, 30mg—100, 500 |
| Additional Resources |
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• Related Prescribing Note |
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