Indications and Usage for Zolpidem
Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem tartrate tablets have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see Clinical Studies (14)].
The clinical trials performed in support of efficacy were 4 to 5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment.
Zolpidem Dosage and Administration
Dosage in Adults
Use the lowest effective dose for the patient. The recommended initial dose is 5 mg for women and either 5 or 10 mg for men, taken only once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening. If the 5 mg dose is not effective, the dose can be increased to 10 mg. In some patients, the higher morning blood levels following use of the 10 mg dose increase the risk of next day impairment of driving and other activities that require full alertness [see Warnings and Precautions (5.1)]. The total dose of Zolpidem tartrate tablets should not exceed 10 mg once daily immediately before bedtime.
The recommended initial doses for women and men are different because Zolpidem clearance is lower in women.
Elderly or debilitated patients may be especially sensitive to the effects of Zolpidem tartrate. Patients with hepatic insufficiency do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem tartrate tablets in both of these patient populations is 5 mg once daily immediately before bedtime [see Warnings and Precautions (5.1); <
Use with CNS Depressants
Dosage adjustment may be necessary when Zolpidem tartrate tablet is combined with other CNS depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.1)].
Dosage Forms and Strengths
Zolpidem tartrate tablets 5 mg are pink, film coated, capsule shaped tablets, debossed with “W714” on one side and plain on the other side. Zolpidem tartrate tablets 10 mg are white, film coated, capsule shaped tablets, debossed with “W715” on one side and plain
on the other side.
Zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to Zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3)].