Zolpidem

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 )

• Use the lowest dose effective for the patient and must not exceed a total of 10 mg daily Treatment should be as short as possible 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 Geriatric patients and patients with mild to moderate hepatic impairment: Recommended dose is 5 mg for men and women Lower doses of CNS depressants may be necessary when taken concomitantly with Zolpidem Tartrate Tablets The effect of Zolpidem Tartrate Tablets may be slowed if taken with or immediately after a meal 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 ]
• 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. …

Zolpidem Tartrate Tablets, USP is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored. Zolpidem Tartrate Tablets, USP 5 mg is pink film coated, round biconvex tab lets, debossed "IT 117" on one side, other side is plain. Zolpidem Tartrate Tablets, USP 10 mg is white film coated, round biconvex tab lets, debossed "IT 118" on one side, other side is plain. …

• Zolpidem Tartrate Tablets is not recommended for use in children
• Safety and effectiveness of Zolpidem
• In pediatric patients below the age of 18 years have not been established
• In an 8-week study, in pediatric patients (aged 6-17 years) with insomnia associated with attention-deficit/hyperactivity disorder (ADHD) an oral solution of Zolpidem Tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. …

A total of 154 patients in U.S. controlled clinical trials and 897 patients in non-U.S. clinical trials who received Zolpidem were ≥60 years of age. For a pool of U.S. patients receiving Zolpidem at doses of ≤10 mg or placebo, there were three adverse reactions occurring at an incidence of at least 3% for Zolpidem and for which the Zolpidem incidence was at least twice the placebo incidence (i.e., they could be considered drug related). …

• 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. …

• Zolpidem Tartrate Tablets is contraindicated in patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Tablets [see Warnings and Precautions ] with known hypersensitivity to zolpidem
• Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions ] Patients who have experienced complex sleep behaviors after taking Zolpidem Tartrate Tablets Known hypersensitivity to Zolpidem

CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.1 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect ( 7.2 ) Ketoconazole: Combination use may increase effect ( 7.2 ) 7.1 CNS-Active Drugs CNS Depressants Coadministration of Zolpidem with other CNS depressants increases the risk of CNS depression. …

CNS-Depressant Effects: Impairs alertness and motor coordination including risk of morning impairment. Risk increases with dose and use with other CNS depressants and alcohol. Caution patients against driving and other activities requiring mental alertness the morning after use. Instruct patients on correct use. ( 5.2 ) Need to Evaluate for Comorbid Diagnoses: Re-evaluate if insomnia persists after 7 to 10 days of use. ( 5.3 ) Severe Anaphylactic/Anaphylactoid Reactions: Angioedema and anaphylaxis have been reported. Do not rechallenge if such reactions occur. …

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

8.1 Pregnancy Risk Summary Neonates born to mothers using Zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of respiratory depression and sedation [see Clinical Considerations and Data]. Published data on the use of Zolpidem during pregnancy have not reported a clear association with Zolpidem and major birth defects [see Data]. …

10.1 Signs and Symptoms In postmarketing experience of overdose with Zolpidem Tartrate alone, or in combination with CNS-depressant agents, impairment of consciousness ranging from somnolence to coma, cardiovascular and/or respiratory compromise, and fatal outcomes have been reported. 10.2 Recommended Treatment General symptomatic and supportive measures should be used along with immediate gastric lavage where appropriate. Intravenous fluids should be administered as needed. …

9.1 Controlled Substance Zolpidem Tartrate is classified as a Schedule IV controlled substance by federal regulation. 9.2 Abuse Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug effects over time. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.