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The dose may be increased to 10 mg if the 5 mg dose is not effective. The clinical trials in support of efficacy were 4 to 5 weeks in duration. The dose may be increased to The clinical trials in support of efficacy were up to 3 and 24 weeks in duration. The recommended initial doses for women and men are different due to the lower rate of drug clearance in females. Short-term treatment of insomnia characterized by difficulties with sleep initiation. As needed treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Men and Women Over the Age of 65 Years: Dose adjustment may be required; however, no specific guidelines have been suggested. Safety and efficacy have not been established in patients younger than 18 years. Advise patients to administer this drug orally once a day immediately before or at bedtime with at least 7 to 8 hours remaining before the planned time of awakening. Advise patients to administer this drug orally once a night as needed if a middle-of-the-night awakening is followed by difficulty returning to sleep AND with at least 4 hours remaining before the planned time of awakening.
Advise patients to swallow this dose form whole, and not to divide, crush, or chew it. Consult the manufacturer product information for instructions on how to administer this dose form. Advise patients to place the tablet under the tongue and allow it to disintegrate completely; this dose form should not be swallowed whole or taken with water.
Advise patients to remove the tablet from the pouch just prior to dosing. Consult the manufacturer product information for management recommendations.