"Nov. 23, 2011 -- Insomniacs wide awake in the wee hours now have a get-back-to-sleep pill -- Intermezzo.
The FDA approved the pill on Wednesday. Designed by Transcept Pharmaceuticals for people who wake in the middle of the night, the"...
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 [see 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.
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 7-8 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 AMBIEN 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 AMBIEN in both of these patient populations is 5 mg once daily immediately before bedtime [see WARNINGS AND PRECAUTIONS; Use in Specific Populations].
Use With CNS Depressants
Dosage adjustment may be necessary when AMBIEN is combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS].
The effect of AMBIEN may be slowed by ingestion with or immediately after a meal.
Dosage Forms And Strengths
AMBIEN is available in 5 mg and 10 mg strength tablets for oral administration. Tablets are not scored.
AMBIEN 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other.
AMBIEN 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other.
Storage And Handling
AMBIEN 5 mg tablets are capsule-shaped, pink, film coated, with AMB 5 debossed on one side and 5401 on the other and supplied as:
|0024-5401-31||bottle of 100|
AMBIEN 10 mg tablets are capsule-shaped, white, film coated, with AMB 10 debossed on one side and 5421 on the other and supplied as:
|0024-5421-31||bottle of 100|
|0024-5421-50||bottle of 500|
Store at controlled room temperature 20°–25°C (68°–77°F).
sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY. Revised: October 2014
Last reviewed on RxList: 10/17/2014
This monograph has been modified to include the generic and brand name in many instances.
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