Zolpidem (Ambien Generic) – 5mg – 30 Tablets

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ZOLPIDEM – ORAL

(ZOHL-pee-dem)

COMMON BRAND NAME(S): Ambien

USES: Zolpidem is used to treat sleep problems (insomnia) in adults. If you have trouble falling asleep, it helps you fall asleep faster, so you can get a better night’s rest. Zolpidem belongs to a class of drugs called sedative-hypnotics. It acts on your brain to produce a calming effect. This medication is usually limited to short treatment periods of 1 to 2 weeks or less.

Usual Adult Dose for Insomnia

IMMEDIATE RELEASE (IR) TABLETS, ORAL SPRAY, and SUBLINGUAL TABLETS (5 and 10 mg formulations):
Initial dose:

• Women: 5 mg orally once a day immediately prior to bedtime
• Men: 5 to 10 mg orally once a day immediately prior to bedtime

Maintenance dose: 5 to 10 mg orally once a day immediately prior to bedtime
Maximum dose: 10 mg/day

CONTROLLED/EXTENDED RELEASE (CR/ER) TABLETS:
Initial dose:

• Women: 6.25 mg orally once a day immediately prior to bedtime
• Men: 6.25 to 12.5 mg orally once a day immediately prior to bedtime

Maintenance dose: 6.25 to 12.5 mg orally once a day immediately prior to bedtime
Maximum dose: 12.5 mg/day

SUBLINGUAL TABLETS (1.75 and 3.5 mg Formulations):
Women: 1.75 mg orally once a day at night as needed

• Maximum dose: 1.75 mg/day

Men: 3.5 mg orally once a day at night as needed

• Maximum dose: 3.5 mg/day

Comments:

• The recommended initial doses for women and men are different due to the lower rate of drug clearance in females.
• Clinical trials supporting IR tablet efficacy were 4 to 5 weeks’ duration, while CR/ER tablet efficacy were 3 to 24 weeks in duration.
• The 1.75 and 3.5 mg sublingual tablet formulations should be taken when the patient wakes in the middle of the night and has trouble falling back to sleep.
• LIMITATION OF USE: The 1.75 and 3.5 mg sublingual tablet formulations are not indicated for the treatment of insomnia in patients who have less than 4 hours of bedtime remaining before the planned awakening time.

Uses:

• IR Tablets, Oral Spray, and Sublingual Tablets (5 and 10 mg Formulations): Short-term treatment of insomnia characterized by difficulties with sleep initiation
• CR/ER Tablets: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset)
• Sublingual Tablets (1.75 and 3.5 mg Formulations): As needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep