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Indications & Usage
1 INDICATIONS AND USAGE Zolpidem Tartrate Tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Zolpidem Tartrate Tablets has 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 4–5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. Zolpidem Tartrate Tablets, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily ( 2.1 ) Treatment should be as short as possible ( 2.1 ) Recommended initial dose is a single dose of 5 mg for women and a single dose of 5 or 10 mg for men, immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening ( 2.1 ) Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and women ( 2.2 ) Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Tablets ( 2.3 ) The effect of Zolpidem Tartrate Tablets may be slowed if taken with or immediately after a meal ( 2.4 ) 2.1 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 7-8 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 ( 5.2 )] . The total dose of Zolpidem Tartrate Tablets should not exceed 10 mg once daily immediately before bedtime. Zolpidem Tartrate Tablets should be taken as a single dose and should not be readministered during the same night. The recommended initial doses for women and men are different because Zolpidem clearance is lower in women. Long-term use of Zolpidem Tartrate Tablets is not recommended. Treatment should be as short as possible. Extended treatment should not take place without re-evaluation of the patient's status because the risk of abuse and dependence increase with the duration of treatment [see Drug Abuse and Dependence ( 9.3 )] 2.2 Special Populations Elderly or debilitated patients may be especially sensitive to the effects of Zolpidem tartrate. The recommended dose of Zolpidem Tartrate Tablets in these patients is 5 mg once daily immediately before bedtime [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.5 )]. Patients with mild to moderate hepatic impairment do not clear the drug as rapidly as normal subjects. The recommended dose of Zolpidem Tartrate Tablets in these patients is 5 mg once daily immediately before bedtime. Avoid Zolpidem Tartrate Tablets use in patients with severe hepatic impairment as it may contribute to encephalopathy [see Warnings and Precautions ( 5.8 ), Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )]. 2.3 Use with CNS Depressants Dosage adjustment may be necessary when Zolpidem Tartrate Tablets is combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions ( 5.2 , 5.7 )]. 2.4 Administration The effect of Zolpidem Tartrate Tablets may be slowed by ingestion with or immediately after a meal.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Complex Sleep Behaviors [see Warnings and Precautions ( 5.1 )] CNS-depressant effects and next-day impairment [see Warnings and Precautions ( 5.2 )] Severe anaphylactic and anaphylactoid reactions [see Warnings and Precautions ( 5.4 )] Abnormal thinking and behavior changes [see Warnings and Precautions ( 5.5 )] Withdrawal effects [see Warnings and Precautions ( 5.9 )] Most commonly observed adverse reactions were: Short-term (2 × ULN, alkaline phosphatase ≥2 × ULN, transaminase ≥5 × ULN). Psychiatric disorders: delirium
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Inform patients and their families about the benefits and risks of treatment with Zolpidem Tartrate Tablets. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with Zolpidem Tartrate Tablets and with each prescription refill. Review the Zolpidem Tartrate Tablets Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that Zolpidem Tartrate Tablets should be taken only as prescribed. Complex Sleep Behaviors Instruct patients and their families that Zolpidem Tartrate Tablets may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue Zolpidem Tartrate Tablets and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning, Warnings and Precautions ( 5.1 )] CNS-Depressant Effects and Next-Day Impairment Tell patients that Zolpidem Tartrate Tablets have the potential to cause next-day impairment, and that this risk is increased if dosing instructions are not carefully followed. Tell patients to wait for at least 8 hours after dosing before driving or engaging in other activities requiring full mental alertness. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients. [see Warnings and Precautions ( 5.2 )] Severe Anaphylactic and Anaphylactoid Reactions Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with Zolpidem. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur. [see Warnings and Precautions ( 5.4 )] Suicide Tell patients to immediately report any suicidal thoughts. Alcohol and other Drugs Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use Zolpidem Tartrate Tablets if they drank alcohol that evening or before bed. Concomitant Use with Opioids Inform patients and caregivers that potentially serious additive effects may occur if Zolpidem Tartrate Tablets is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.2 , 5.7 ), Drug Interactions ( 7.1 )] . Tolerance, Abuse, and Dependence Tell patients not to increase the dose of Zolpidem Tartrate Tablets on their own, and to inform you if they believe the drug "does not work." Administration Instructions Patients should be counseled to take Zolpidem Tartrate Tablets right before they get into bed and only when they are able to stay in bed a full night (7-8 hours) before being active again. Zolpidem Tartrate Tablets should not be taken with or immediately after a meal. Advise patients NOT to take Zolpidem Tartrate Tablets if they drank alcohol that evening. Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Zolpidem Tartrate Tablets. Advise patients that use of Zolpidem Tartrate Tablets late in the third trimester may cause respiratory depression and sedation in neonates. Advise mothers who used Zolpidem Tartrate Tablets during the late third trimester of pregnancy to monitor neonates for signs of sleepiness (more than usual), breathing difficulties, or limpness [see Use in Specific Populations ( 8.1 )]. Lactation Advise breastfeeding mothers using Zolpidem Tartrate Tablets to monitor infants for increased sleepiness, breathing difficulties, or limpness. Instruct breastfeeding mothers to seek immediate medical care if they notice these signs. A lactating woman may consider pumping and discarding breastmilk during treatment and for 23 hours after Zolpidem Tartrate Tablets administration to minimize drug exposure to a breastfed infant [see Use in Specific Populations ( 8.2 )]. Manufactured for: The ACME Laboratories Ltd. Dhulivita, Dhamrai, Dhaka, 1350 Bangladesh Distributed by: ACI Healthcare USA, Inc. 10100 W. Sample Road, Suite 406 Coral Springs, FL 3306 Revised: 6/2023
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.