Zolpidem Dosage

Usual Adult Dose for Insomnia

Immediate release:
Men: 10 mg orally once daily immediately before bedtime
Women: 5 mg orally once daily immediately before bedtime

Alternatively, the dose may be administered as a sublingual tablet placed under the tongue to disintegrate once a day immediately before bedtime. The sublingual tablet should not be swallowed or taken with water. The recommended duration of zolpidem therapy is generally 7 to 10 days. Each metered actuation (one spray) of zolpidem tartrate oral spray delivers 5 mg of zolpidem.

Controlled release:
Men: 12.5 mg orally once daily immediately before bedtime
Women: 6.25 mg orally once daily immediately before bedtime

Sublingual: The recommended and maximum dose is 1.75 mg SL for women and 3.5 mg SL for men only once per night (to be taken only if the patient has at least 4 hours of bedtime remaining before the planned time of waking).

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

The safety of immediate release zolpidem has only been established for treatment regimens of up to 5 weeks. Administration of immediate release zolpidem for therapies longer than 5 weeks is not recommended.

Comments: FDA is recommending 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. This includes products which are marketed as generics and under the brand names Ambien (R), Ambien CR (R), Edluar (R), and Zolpimist (R). Patients who take insomnia drugs can experience impairment of mental alertness even if they feel fully awake. The risk for next morning impairment is highest for patients taking the extended-release forms. FDA is requiring manufacturers to lower the dose for women from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for extended-release products. FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next morning impairment for activities that require mental alertness. The recommended doses of Intermezzo (R), a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

Usual Geriatric Dose for Insomnia

Immediate release: 5 mg once a day immediately before bedtime. Alternatively, the dose may be administered as one 5 mg sublingual tablet placed under the tongue to disintegrate. The sublingual tablet should not be swallowed or taken with water. The recommended duration of zolpidem therapy is generally 7 to 10 days. The dosage can be titrated up to 10 mg nightly if necessary depending on patient response.

Controlled release: 6.25 mg orally once a day immediately before bedtime.

Sublingual: The recommended and maximum dose is 1.75 mg only once per night (to be taken only if the patient has at least 4 hours of bedtime remaining before the planned time of waking).

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

The safety of immediate release zolpidem has only been established for treatment regimens of up to five weeks. Administration of immediate release zolpidem for therapies longer than five weeks is therefore not recommended.

Comments: FDA is recommending 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. This includes products which are marketed as generics and under the brand names Ambien (R), Ambien CR (R), Edluar (R), and Zolpimist (R). Patients who take insomnia drugs can experience impairment of mental alertness even if they feel fully awake. The risk for next morning impairment is highest for patients taking the extended-release forms. FDA is requiring manufacturers to lower the dose for women from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for extended-release products. FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next morning impairment for activities that require mental alertness. The recommended doses of Intermezzo (R), a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Immediate release: 5 mg once a day immediately before bedtime. Alternatively, the dose may be administered as one 5 mg sublingual tablet placed under the tongue to disintegrate. The sublingual tablet should not be swallowed or taken with water. The recommended duration of zolpidem therapy is generally 7 to 10 days.

Controlled release: 6.25 mg orally once a day immediately before bedtime.

Sublingual: 1.75 mg SL only once per night if needed (to be taken only if the patient has at least 4 hours of bedtime remaining before the planned time of waking).

Dose Adjustments

The recommended zolpidem sublingual 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 because of potentially additive effects.

Comments: FDA is recommending 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. This includes products which are marketed as generics and under the brand names Ambien (R), Ambien CR (R), Edluar (R), and Zolpimist (R). Patients who take insomnia drugs can experience impairment of mental alertness even if they feel fully awake. The risk for next morning impairment is highest for patients taking the extended-release forms. FDA is requiring manufacturers to lower the dose for women from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for extended-release products. FDA urges health care professionals to caution all patients (men and women) who use these products about the risks of next morning impairment for activities that require mental alertness. The recommended doses of Intermezzo (R), a lower dose zolpidem product approved for middle-of-the-night awakenings, are not changing.

Precautions

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

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Patients should be counseled to take zolpidem right before they get into bed and only when they are able to stay in bed a full night (7 to 8 hours) before being active again.

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.

Sublingual: 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 tartrate 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.

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