Zolpidem Capsules

The kind of sleep your patients are looking for.

Actor portrayal.

Zolpidem Tartrate 7.5 mg Capsules provide an additional dosing option to help patients with insomnia fall asleep faster and stay asleep longer compared with placebo.12

Sleep parameters

In a clinical study comparing the effects of another 7.5 mg zolpidem dose with placebo, volunteers experienced decreased sleep latency, increased sleep efficiency, and increased sleep maintenance.2

Variable	Placebo (n=102)	Zolpidem 7.5 mg (n=102)
Mean sleep latency (minutes)
Polysomnography	27.1 ± 2.6*	17.0 ± 1.4 (P<0.001)†
Patient assessment	28.8 ± 3.0	18.9 ± 1.2 (P=0.009)*
Sleep efficiency‡ (measured by polysomnography)	87.8 ± 3.0	91.7 ± 0.7 (P<0.001)†
Sleep maintenance (measured by polysomnography)
Number of awakenings	6.7 ± 0.4	5.0 ± 0.3 (P=0.004)†
Wake time during sleep (minutes)	31.4 ± 3.1	21.2 ± 2.4 (P=0.004)†
The 5 mg, 10 mg, 15 mg, and 20 mg zolpidem results, along with overall P values, have been removed from the original version of this table. To view the original table, see Roth T, Roehrs T, Vogel G. Sleep. 1995;18(4):246-251.	^*Data were unavailable for 1 patient. ^†Compared with placebo. ^‡Sleep efficiency=total time asleep/time in bed.

Next-day performance and alertness

In the same clinical study comparing the effects of another 7.5 mg zolpidem dose with placebo, next-day performance test scores showed no statistically significant differences.2

Variable	Placebo (n=102)	Zolpidem 7.5 mg (n=102)
Digit Symbol Substitution Test	53.9 ± 1.6	54.3 ± 1.3
Symbol Copying Test	121.1 ± 2.7	119.1 ± 2.5
Ability to concentrate§	1.9 ± 0.1	1.8 ± 0.1
Morning sleepiness¶	69.0 ± 2.3	64.0 ± 2.5
Daytime sleepiness\|\|	39.2%	31.0%
Drugged feeling**	85.6 ± 1.9	85.2 ± 2.0
The 5 mg, 10 mg, 15 mg, and 20 mg zolpidem results, along with overall P values, have been removed from the original version of this table. To view the original table, see Roth T, Roehrs T, Vogel G. Sleep. 1995;18(4):246-251.	^§1=excellent, 2=very good, 3=fair, 4=poor. ^¶Not at all sleepy, 100=very sleepy. ^\|\|Percent responding yes. ^**0=very drugged, 100=not at all drugged.

In another study, there was a small but statistically significant decrease in performance of the Digit Symbol Substitution Test compared with placebo.1

Prescribing Zolpidem Tartrate 7.5 mg Capsules1

Zolpidem Tartrate Capsules are only available in a 7.5 mg dose strength. Use another zolpidem tartrate product for 5 mg and 10 mg doses. Use the lowest effective dose for the patient
In both males and females: If a 5 mg nightly dose of another zolpidem tartrate immediate-release product is not effective, the zolpidem tartrate dosage may be increased to Zolpidem Tartrate 7.5 mg Capsules once nightly or 10 mg once nightly of another zolpidem tartrate immediate-release product. The maximum recommended dosage of zolpidem tartrate immediate-release is 10 mg once nightly
Zolpidem Tartrate 7.5 mg Capsules should not be taken with or immediately after a meal
Avoid use of Zolpidem Tartrate 7.5 mg Capsules in geriatric patients

For additional dosage, administration, and safety information about Zolpidem Tartrate 7.5 mg Capsules, click here for the Full Prescribing Information.

Automatic savings at the pharmacy counter with eVoucherRx™††

Eligible, commercially insured patients enjoy automatic savings at over 50,000 pharmacies nationwide. Copay savings are automatically applied at the pharmacy counter, without any action required by the patients.

Zolpidem Tartrate eVoucher Program Terms and Conditions: The Almatica Zolpidem Tartrate eVoucher Program helps commercially insured individuals, 18 years of age or older who are permanent residents of the United States (including the United States Territories) and who are prescribed/dispensed Almatica-labeled Zolpidem Tartrate Capsules for a use approved by the Food and Drug Administration pay for their eligible copay for Almatica-labeled Zolpidem Tartrate Capsules. Under the program, eligible commercially insured patients may pay as little as $10 per 30-day supply of Almatica-labeled Zolpidem Tartrate Capsules. A maximum savings limit per 30-day supply applies. The eVoucher automatically applies at over 50,000 pharmacies nationwide without any action required by patients. Patients with drug coverage under Medicare, Medicaid or TRICARE are not eligible for the Almatica Zolpidem Tartrate eVoucher Program. Furthermore, patients residing in any state where such assistance is prohibited by law are not eligible for the Almatica Zolpidem Tartrate eVoucher Program. This offer is void if copied, transferred, purchased, altered, or traded. The Almatica Zolpidem Tartrate eVoucher Program is not insurance. Almatica reserves the right to change, rescind, revoke, or discontinue the program at any time without notice. Limit one program enrollment per individual. If you have any questions regarding this program, your eligibility, or benefits or if you wish to discontinue your participation in the program, please call 844-889-8686, option 1.

INDICATION FOR USE

Zolpidem Tartrate Capsules are indicated for the short-term treatment of transient insomnia characterized by difficulties with sleep initiation in adults younger than 65 years of age.

CONTRAINDICATIONS

Zolpidem Tartrate Capsules are contraindicated in patients

who have experienced complex sleep behaviors after taking zolpidem
with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS

CNS-Depressant Effects and Next-Day Impairment

Zolpidem tartrate has CNS-depressant effects and coadministration with other CNS depressants increases the risk. Dosage adjustments of zolpidem tartrate and of other concomitant CNS depressants may be necessary. The use of Zolpidem Tartrate Capsules with other sedative-hypnotics at bedtime or the middle of the night is not recommended.
The risk of next-day psychomotor impairment, including impaired driving, is increased if Zolpidem Tartrate Capsules are taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dosage is taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase the blood levels of zolpidem. Patients should be warned against driving and other activities requiring complete mental alertness if Zolpidem Tartrate Capsules are taken in these circumstances.

Need to Evaluate for Comorbid Diagnoses

Symptomatic treatment of insomnia should be initiated only after careful evaluation of the patient. If insomnia continues after 7 to 10 days of Zolpidem Tartrate Capsules, this may indicate a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder.

Severe Anaphylactic and Anaphylactoid Reactions

Cases of angioedema involving the tongue, glottis or larynx have been reported and can be fatal. Patients who develop angioedema after treatment with Zolpidem Tartrate Capsules should not be rechallenged with zolpidem tartrate.

Abnormal Thinking and Behavioral Changes

Abnormal thinking and behavior changes have been reported in patients treated with zolpidem tartrate immediate-release. Some of these changes included decreased inhibition, bizarre behavior, agitation and depersonalization. Visual and auditory hallucinations have been reported.

Use in Patients with Depression

In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughts and actions (including completed suicides), have been reported. Intentional overdosage is more common in this group of patients; therefore, the lowest number of Zolpidem Tartrate Capsules that is feasible should be prescribed for the patient at any one time.

Respiratory Depression

The risk of respiratory depression should be considered and precautions should be taken if Zolpidem Tartrate Capsules are prescribed to patients with compromised respiratory function or concomitant use with opioids or other CNS depressants.

Precipitation of Hepatic Encephalopathy

Zolpidem tartrate has been associated with precipitation of hepatic encephalopathy in patients with hepatic insufficiency. Avoid Zolpidem Tartrate Capsules use in patients with severe hepatic impairment.

Withdrawal Effects

There have been reports of withdrawal signs and symptoms following the rapid dose decrease or abrupt discontinuation of zolpidem tartrate. Monitor patients for tolerance, abuse, and dependence.

ADVERSE REACTIONS

Most commonly observed adverse reactions were headache, drowsiness, dizziness, and diarrhea.

DRUG INTERACTIONS

Imipramine and Chlorpromazine: Impaired alertness and psychomotor performance observed
CYP3A4 inducers: Combination use may decrease effect
CYP3A4 inhibitors: Combination use may increase effect

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause respiratory depression and sedation in neonates with exposure late in the third trimester.
Lactation: A lactating woman may pump and discard breast milk during treatment and for 23 hours after Zolpidem Tartrate Capsules administration.
Hepatic Impairment: Avoid use.

For additional safety information about Zolpidem Tartrate Capsules, click here for the Zolpidem Tartrate Capsules Full Prescribing Information.

References:

Zolpidem Tartrate Capsules. Prescribing information. Almatica Pharma LLC; 2023.
Roth T, Roehrs T, Vogel G. Zolpidem in the treatment of transient insomnia: a double-blind, randomized comparison with placebo. Sleep. 1995;18(4):246-251. (The zolpidem capsules administered during the Roth study are not Almatica products.)