ZOLPIDEM TARTRATE
ZOLPIDEM TARTRATE is one of 8,063 medications in the MedPlain dataset. Key details — Brand name: ZOLPIDEM TARTRATE; Generic name: ZOLPIDEM TARTRATE; Manufacturer: Aphena Pharma Solutions - Tennessee, LLC.
| Brand name | ZOLPIDEM TARTRATE |
|---|---|
| Generic name | ZOLPIDEM TARTRATE |
| Manufacturer | Aphena Pharma Solutions - Tennessee, LLC |
| Used for | 1 INDICATIONS AND USAGE Zolpidem tartrate extended-release tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset).) The clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see CLINICAL STUDIES ( 14 )]. Zolpidem tartrate extended-release tablet, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficult |
| Dosage | 2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient and must not exceed a total of 12.5 mg daily ( 2.1 ) Treatment should be as short as possible ( 2.1 ) Recommended initial dose is a single dose of 6.25 mg for women, and a single dose of 6.25 or 12.5 mg for men, immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening ( 2.1 ) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 6.25 mg for |
| Warnings | WARNING: COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of zolpidem tartrate extended-release tablets. Some of these events may result in serious injuries, including death. Discontinue zolpidem tartrate extended-release tablets immediately if a patient experiences a complex sleep behavior [see CONTRAINDICATIONS ( 4 ) and WARNINGS AND PRECAUTIONS ( 5.1 )] . WARNING: COMPLEX SLEE |
| Active ingredient(s) | ZOLPIDEM TARTRATE |
| Route | ORAL |
| Official label | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=08411424-e8a8-4964-bd04-5b0b5aa5baaf |