Zolpidem Tartrate

ZOLPIDEM TARTRATE- zolpidem tartrate capsule
Almatica Pharma LLC

WARNING: COMPLEX SLEEP BEHAVIORS

Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of Zolpidem Tartrate Capsules. Some of these events may result in serious injuries, including death. Discontinue Zolpidem Tartrate Capsules immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

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 [see Dosage and Administration (2.1) and Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage Information

Zolpidem Tartrate Capsules are only available in a 7.5 mg strength. Use another zolpidem tartrate immediate-release product for the 5 mg or 10 mg dose of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products.

  • Zolpidem Tartrate Capsules are not indicated in geriatric patients. Avoid use of Zolpidem Tartrate Capsules in geriatric patients because the recommended dosage in these patients cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength [see Use in Specific Populations (8.5)]. Use another zolpidem tartrate product for geriatric patients.
  • The recommended starting dosage for females is different than males because zolpidem clearance is lower in females [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Do not use Zolpidem Tartrate Capsules to initiate zolpidem tartrate treatment in females because the recommended starting dosage in females cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength. Use another zolpidem tartrate immediate-release product to initiate treatment in females [see Dosage and Administration (2.2)].
  • Avoid Zolpidem Tartrate Capsules in patients with mild or moderate hepatic impairment because the recommended dosage in such patients cannot be achieved with the Zolpidem Tartrate Capsules 7.5 mg strength [see Warnings and Precautions (5.8), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
  • Avoid any zolpidem tartrate use in patients with severe hepatic impairment because its use may contribute to encephalopathy [see Warnings and Precautions (5.8), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

2.2 Recommended Dosage

Use the lowest effective zolpidem tartrate dosage. For instructions on administration of Zolpidem Tartrate Capsules, see Dosage and Administration (2.4).

  • The recommended starting dosage of zolpidem tartrate immediate-release in females is 5 mg once nightly. Use another zolpidem tartrate immediate-release product for dosage initiation in females [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
  • The recommended starting dosage of zolpidem tartrate immediate-release in males is either zolpidem tartrate immediate-release 5 mg, Zolpidem Tartrate Capsules 7.5 mg, or zolpidem tartrate immediate-release 10 mg, once nightly.

In both males and females, if a 5 mg once nightly dose of another zolpidem tartrate immediate-release product is not effective, the zolpidem tartrate dosage may be increased to Zolpidem Tartrate Capsules 7.5 mg 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 Capsules should be taken as a single dose and should not be readministered during the same night.

2.3 Recommended Duration of Treatment

Zolpidem Tartrate Capsules are for short-term use only. Re-evaluate the patient’s status during treatment because the risk of abuse and dependence increases with duration of treatment [see Drug Abuse and Dependence (9.3)].

2.4 Administration Instructions

Administer Zolpidem Tartrate Capsules orally once per night immediately before bedtime with at least 7 to 8 hours remaining before the planned time of awakening [see Warnings and Precautions (5.2)].

Zolpidem Tartrate Capsules should not be administered with food or immediately after a meal [see Clinical Pharmacology (12.3)]. Swallow Zolpidem Tartrate Capsules whole; do not open, crush, or chew.

2.5 Dosage Modifications with CNS Depressants

Dosage modifications may be necessary when Zolpidem Tartrate Capsules are combined with other CNS-depressant drugs because of the potentially additive effects [see Warnings and Precautions (5.2, 5.7)]. Use another zolpidem tartrate immediate-release product for the 5 mg dosage of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products.

3 DOSAGE FORMS AND STRENGTHS

Capsules: 7.5 mg, hard gelatin capsules with “ALM” printed axially on the opaque light green cap and “775” printed axially on the opaque white body. All printing is in grey ink.

4 CONTRAINDICATIONS

Zolpidem Tartrate Capsules are contraindicated in patients:

  • who have experienced complex sleep behaviors after taking zolpidem [see Warnings and Precautions (5.1)].
  • with known hypersensitivity to zolpidem. Observed reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.4)].

5 WARNINGS AND PRECAUTIONS

5.1 Complex Sleep Behaviors

Complex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fully awake, may occur following the first or any subsequent use of Zolpidem Tartrate Capsules. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. Other complex sleep behaviors (e.g., preparing and eating food, making phone calls, or having sex) have also been reported. Patients usually do not remember these events. Postmarketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosage, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants [see Drug Interactions (7)]. Discontinue Zolpidem Tartrate Capsules immediately if a patient experiences a complex sleep behavior [see Contraindications (4)].

5.2 CNS-Depressant Effects and Next-Day Impairment

Zolpidem tartrate, like other sedative-hypnotic drugs, has CNS-depressant effects. Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression [see Drug Interactions (7)]. Dosage adjustments of zolpidem tartrate and of other concomitant CNS depressants may be necessary when Zolpidem Tartrate Capsules are administered with such agents because of the potentially additive effects. Use another zolpidem tartrate immediate-release product for the 5 mg dose of zolpidem tartrate immediate-release. Refer to the Prescribing Information of other zolpidem tartrate immediate-release products for the recommended dosage for those products. The use of Zolpidem Tartrate Capsules with other sedative-hypnotics (including other zolpidem products) at bedtime or the middle of the night is not recommended [see Dosage and Administration (2.5)].

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 [see Dosage and Administration (2.5), Clinical Studies (14.2)]. Vehicle drivers and machine operators should be warned that, as with other hypnotics, there may be a possible risk of adverse reactions including drowsiness, prolonged reaction time, dizziness, sleepiness, blurred/double vision, reduced alertness, and impaired driving the morning after therapy. In order to minimize this risk a full night of sleep (7 to 8 hours) is recommended.

Because Zolpidem Tartrate Capsules can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.