"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 CR (zolpidem tartrate extended-release tablets) is indicated for the 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 patientreported assessment in adult patients only) in duration [see Clinical Studies].
DOSAGE AND ADMINISTRATION
Dosage In Adults
Use the lowest effective dose for the patient. The recommended initial dose is 6.25 mg for women and either 6.25 or 12.5 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 6.25 mg dose is not effective, the dose can be increased to 12.5 mg. In some patients, the higher morning blood levels following use of the 12.5 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 CR should not exceed 12.5 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 CR in both of these patient populations is 6.25 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 CR is combined with other CNS depressant drugs because of the potentially additive effects [see WARNINGS AND PRECAUTIONS].
AMBIEN CR extended-release tablets should be swallowed whole, and not be divided, crushed, or chewed. The effect of AMBIEN CR may be slowed by ingestion with or immediately after a meal.
Dosage Forms And Strengths
AMBIEN CR is available as extended-release tablets containing 6.25 mg or 12.5 mg of zolpidem tartrate for oral administration. Tablets are not scored.
AMBIEN CR 6.25 mg tablets are pink, round, bi-convex, and debossed with A~ on one side.
AMBIEN CR 12.5 mg tablets are blue, round, bi-convex, and debossed with A~ on one side.
Storage And Handling
AMBIEN CR 6.25 mg tablets are composed of two layers* and are coated, pink, round, biconvex, debossed with A~ on one side and supplied as:
|0024-5501-31||bottle of 100|
AMBIEN CR 12.5 mg tablets are composed of two layers* and are coated, blue, round, biconvex, debossed with A~ on one side and supplied as:
|0024-5521-31||bottle of 100|
|0024-5521-50||bottle of 500|
|0024-5521-10||carton of 30 unit dose|
|*Layers are covered by the coating and are indistinguishable.|
Store between 15°-25° C (59°-77°F). Limited excursions permissible up to 30° C (86°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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