Zolpidem Capsules

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.