"The U.S. Food and Drug Administration today announced it required the manufacturer of the sleep drug Lunesta (eszopiclone) to change the drug label and lower the current recommended starting dose. Data show that eszopiclone levels in some patient"...
HALCION is indicated for the short-term treatment of insomnia (generally 7–10 days). Use for more than 2– 3 weeks requires complete reevaluation of the patient (see WARNINGS).
Prescriptions for HALCION should be written for short-term use (7–10 days) and it should not be prescribed in quantities exceeding a 1-month supply.
DOSAGE AND ADMINISTRATION
It is important to individualize the dosage of HALCION Tablets for maximum beneficial effect and to help avoid significant adverse effects.
The recommended dose for most adults is 0.25 mg before retiring. A dose of 0.125 mg may be found to be sufficient for some patients (e.g., low body weight). A dose of 0.5 mg should be used only for exceptional patients who do not respond adequately to a trial of a lower dose since the risk of several adverse reactions increases with the size of the dose administered. A dose of 0.5 mg should not be exceeded.
In geriatric and/or debilitated patients the recommended dosage range is 0.125 mg to 0.25 mg. Therapy should be initiated at 0.125 mg in these groups and the 0.25 mg dose should be used only for exceptional patients who do not respond to a trial of the lower dose. A dose of 0.25 mg should not be exceeded in these patients.
As with all medications, the lowest effective dose should be used.
HALCION Tablets are available in the following strengths and package sizes:
0.25 mg (powder blue, elliptical, scored, imprinted HALCION 0.25):
Unit Dose (100) NDC 0009-0017-55
10–10 Tablet Bottles NDC 0009-0017-59
Bottles of 10 NDC 0009-0017-58
Bottles of 500 NDC 0009-0017-02
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Distributed by: Pharmacia & Upjohn Co., Division of Pfizer Inc., NY, NY 10017. Revised September 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/2/2014
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