Zolpidem

AMBIEN (zolpidem tartrate) is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. AMBIEN has been shown to decrease sleep latency for up to 35 days in controlled clinical studies. 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. AMBIEN, a gamma-aminobutyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.

Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α1 subunit containing GABA A receptors, increasing the frequency of chloride channel opening resulting in the inhibition of neuronal excitation.

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 AMBIEN. The effect of AMBIEN may be slowed if taken with or immediately after a meal

AMBIEN is contraindicated in patients who have experienced complex sleep behaviors after taking AMBIEN. with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema. Patients who have experienced complex sleep behaviors after taking AMBIEN. Known hypersensitivity to zolpidem

Boxed 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 AMBIEN. Some of these events may result in serious injuries, including death. Discontinue AMBIEN immediately if a patient experiences a complex sleep behavior. CNS-Depressant Effects: Impaired 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. Need to Evaluate for Comorbid Diagnoses: Reevaluate if insomnia persists after 7 to 10 days of use. 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 CNS-Depressant Effects and Next-Day Impairment Severe Anaphylactic and Anaphylactoid Reactions Abnormal Thinking and Behavior Changes Withdrawal Effects Most commonly observed adverse reactions were: Short-term (<10 nights): Drowsiness, dizziness, and diarrhea Long-term (28–35 nights): Dizziness and drugged feelings

CNS depressants, including alcohol: Possible adverse additive CNS-depressant effects. Opioids: Concomitant use may increase risk of respiratory depression. Imipramine: Decreased alertness observed. Chlorpromazine: Impaired alertness and psychomotor performance observed. CYP3A4 inducers (rifampin or St. John's wort): Combination use may decrease effect. Ketoconazole: Combination use may increase effect

Store at controlled room temperature 20°C–25°C (68°F–77°F).