Zolpidem Dosage

Usual Adult Dose for Insomnia

Use the lowest dose possible to minimize the risk of next day impairment of activities that require full alertness.

For the short-term treatment of insomnia characterized by difficulties with sleep initiation:

-IMMEDIATE-RELEASE TABLETS:
5 mg (women) or 5 to 10 mg (men) orally once daily immediately before bedtime
Maximum dose: 10 mg orally daily

-SUBLINGUAL TABLETS:
EDLUAR (R):
5 mg (women) or 5 to 10 mg (men) placed under the tongue to disintegrate once a day immediately before bedtime with at least 7 to 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.

-ORAL SPRAY:
5 mg (women) or 5 to 10 mg (men) orally once daily immediately before bedtime
Maximum dose: 10 mg orally daily

COMMENTS:
-The recommended duration of zolpidem therapy is generally 7 to 10 days.
-The sublingual tablet should not be swallowed or taken with water.
-Each metered actuation (one spray) of zolpidem tartrate oral spray delivers 5 mg of zolpidem.

For insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset):

-EXTENDED-RELEASE TABLETS:
Initial dose:
6.25 mg (women) or 6.25 to 12.5 mg (men) orally once daily immediately before bedtime
Maximum dose: 12.5 mg orally once daily immediately before bedtime

COMMENTS:
-If the 6.25 mg dose is not effective, the dose can be increased to 12.5 mg.

For use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep if the patient has at least 4 hours of bedtime remaining before the planned time of waking:

SUBLINGUAL TABLETS:
-INTERMEZZO (R):
Recommended and maximum dose:
1.75 mg (women) or 3.5 mg (men) SL only once per night

COMMENTS:
-Intermezzo (R) should be taken in bed when a patient wakes in the middle of the night and has difficulty returning to sleep. Place under the tongue and allow to disintegrate completely before swallowing. The tablet should not be swallowed whole and not administered with or immediately after a meal.
-Remove from the pouch just prior to dosing.

Usual Geriatric Dose for Insomnia

For the short-term treatment of insomnia characterized by difficulties with sleep initiation:
-IMMEDIATE-RELEASE TABLETS, ORAL SPRAY, and EDLUAR (R) SUBLINGUAL TABLETS:
Recommended dose:
5 mg orally once daily immediately before bedtime

For insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset):
-EXTENDED-RELEASE TABLETS:
Recommended dose:
6.25 mg orally once daily immediately before bedtime

For use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep if the patient has at least 4 hours of bedtime remaining before the planned time of waking:
-INTERMEZZO (R) SUBLINGUAL TABLETS:
Recommended and maximum dose:
Men and women over 65 years of age: 1.75 mg SL taken only once per night if the patient has at least 4 hours of bedtime remaining before the planned time of waking.

Renal Dose Adjustments

No dosage adjustment recommended.

Liver Dose Adjustments

-IMMEDIATE-RELEASE TABLETS, ORAL SPRAY, and EDLUAR (R) SUBLINGUAL TABLETS:
Recommended dose:
5 mg orally once daily immediately before bedtime

-EXTENDED-RELEASE TABLETS:
Recommended dose:
6.25 mg orally once daily immediately before bedtime

-INTERMEZZO (R) SUBLINGUAL TABLETS:
Recommended and maximum dose:
1.75 mg SL taken only once per night if the patient has at least 4 hours of bedtime remaining before the planned time of waking.

Dose Adjustments

For patients taking concomitant antidepressants:
-Zolpidem like other sedative-hypnotic drugs has central nervous system (CNS) depressant effects. Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of zolpidem in any form and of other concomitant CNS depressants may be necessary when zolpidem is administered with these drugs because of the potentially additive effects.
-The recommended Intermezzo (R) sublingual tablet dose for men and women who are taking concomitant CNS depressants is 1.75 mg. Dose adjustment of concomitant CNS depressants may be necessary when coadministered with Intermezzo (R) because of potentially additive effects.

FDA has recommended that the bedtime dose of zolpidem be lowered because blood levels in some patients may be high enough the morning to impair activities that require alertness, including driving. Women are more susceptible to this risk because they eliminate zolpidem more slowly than men. The recommended doses of Intermezzo (R), a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

Dialysis

Zolpidem is not dialyzable.

Other Comments

Zolpidem tablets should not be taken with or immediately after a meal.

Women clear zolpidem from the body at a lower rate than men; therefore, men can tolerate higher doses.

Immediate-release: The maximum recommended dose is 10 mg per day. Duration of therapy is generally 7 to 10 days. Administration for longer than 5 weeks is not recommended.

Controlled-release: The maximum recommended dose is 12.5 mg per day. The tablet should be swallowed whole, and not divided, crushed, or chewed.

Intermezzo (R) sublingual tablets: Should only be taken if the patient has at least 4 hours of bedtime remaining before the planned time of waking. Tablets should be allowed to disintegrate completely under the tongue before swallowing and not swallowed whole.

Each metered actuation (one spray) of zolpidem oral spray delivers 5 mg of zolpidem.

After an initial priming of 5 actuations of the oral spray, there are 60 metered actuations in each container. The total number of available doses is dependent on the number of actuations per dose (1 or 2 actuations) and the frequency of priming.

The use of Intermezzo (R) sublingual tablets with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

If zolpidem is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.

Intermezzo (R) sublingual tablets: Should only be taken if the patient has at least 4 hours of bedtime remaining before the planned time of waking. Tablets should be allowed to disintegrate completely under the tongue before swallowing and not swallowed whole.

Each metered actuation (one spray) of zolpidem oral spray delivers 5 mg of zolpidem.

After an initial priming of 5 actuations of the oral spray, there are 60 metered actuations in each container. The total number of available doses is dependent on the number of actuations per dose (1 or 2 actuations) and the frequency of priming.

The use of Intermezzo (R) sublingual tablets with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended.

If zolpidem is used daily for more than a few weeks, abrupt discontinuation is not recommended. Such cessation may precipitate symptoms of withdrawal.