Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

ZOLPIMIST (NDA-022196)

(ZOLPIDEM TARTRATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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08/18/2019 (SUPPL-12)

Approved Drug Label (PDF)

Boxed Warning

Newly added:

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 ZOLPIMIST. Some of these events may result in serious injuries, including death. Discontinue ZOLPIMIST immediately if a patient experiences a complex sleep behavior.

4 Contraindications

Additions and/or revisions underlined:

ZOLPIMIST is contraindicated in patients:

who have experienced complex sleep behaviors after taking ZOLPIMIST

5 Warnings and Precautions

Newly added subsection:

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. 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. Post-marketing reports have shown that complex sleep behaviors may occur with zolpidem alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants. Discontinue ZOLPIMIST immediately if a patient experiences a complex sleep behavior.

6 Adverse Reactions

Underlined additions of the following to the bulleted line listing:

Complex Sleep Behaviors
CNS-Depressant Effects and Next Day Impairment

6.1 Clinical Trials Experience

Respiratory System

Addition of ‘lower respiratory infection’ and ‘respiratory depression’

8 Use in Specific Populations

8.1 Pregnancy

Additions and/or revisions underlined:

Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS depressants. Children born to mothers taking sedative- hypnotic drugs may be at risk for withdrawal symptoms during the postnatal period. Neonatal flaccidity has also been reported in infants born to mothers who received sedative-hypnotic drugs during pregnancy. ZOLPIMIST should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus.

Administration of zolpidem to pregnant rats … than the zolpidem tartrate maximum recommended human dose (MRHD) of 10 mg/day (approximately 8 mg/day zolpidem base) …

When zolpidem was administered at oral doses of 4, 20, and 100 mg base/kg/day to pregnant rats during the period of organogenesis, dose-related decreases in fetal skull ossification occurred at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m2 basis. In rabbits treated during organogenesis with zolpidem at oral doses of 1, 4, and 16 mg base/kg/day, increased embryo-fetal death and incomplete fetal skeletal ossification occurred at the highest dose tested. The no-effect dose for embryo-fetal toxicity in rabbits is approximately 10 times the MRHD on a mg/m2 basis. Administration of zolpidem to rats at oral doses of 4, 20, and 100 mg base/kg/day during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose, which is approximately 5 times the MRHD on a mg/m2 basis.

8.4 Pediatric Use

Additions and/or revisions underlined:

ZOLPIMIST is not recommended for use in children. Safety and effectiveness of zolpidem in pediatric patients below the age of 18 years have not been established.

In an 8-week controlled study of pediatric patients (6-17 years of age) with insomnia associated with attention- deficit/hyperactivity-disorder (ADHD) an oral solution of zolpidem tartrate dosed at 0.25 mg/kg at bedtime did not decrease sleep latency compared to placebo. Psychiatric and nervous system disorders comprised the most frequent (>5%) treatment emergent adverse reactions observed with zolpidem versus placebo and included dizziness (23.5% vs. 1.5%), headache (12.5% vs. 9.2%), and hallucinations were reported in 7% of the pediatric patients who received zolpidem; none of the pediatric patients who received placebo reported hallucinations …

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

Additions and/or revisions underlined:

What is the most important information I should know about ZOLPIMIST?

Complex sleep behaviors that have caused serious injury and death … that you do not know you are doing (complex sleep behaviors). These activities may happen whether or not you drink alcohol …

Stop taking Zolpimist and call your doctor right away …

Important:

Do not take ZOLPIMIST if you:

have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking ZOLPIMIST.

Keep ZOLPIMIST and all medicines out of reach of children.

General Information about ZOLPIMIST

… For more information about ZOLPIMIST, call 1- 855-298-8246.

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Complex Sleep Behaviors

Instruct patients and their families that ZOLPIMIST may cause complex sleep behaviors, including sleep- walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue ZOLPIMIST and notify their healthcare provider immediately if they develop any of these symptoms.

CNS-Depressant Effects and Next-Day Impairment

Inform patients that ZOLPIMIST should be administered …

02/06/2019 (SUPPL-11)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.5 CNS-depressant effects

(additions underlined)

…

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

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

MEDICATION GUIDE

(additions underlined)

…

General Information about Zolpimist

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
Do not use Zolpimist for a condition for which it was not prescribed.
Do not share Zolpimist with other people, even if you think they may have the same symptoms that you have. It may harm them and it is against the law.

…

PATIENT COUNSELING INFORMATION

(new subsection added)

17.3 CNS-depressant effects

Inform patients that Zolpimist should be administered immediately prior to going to bed. Caution patients against engaging in hazardous occupations requiring complete mental alertness or motor coordination such as driving. Inform patients that potential impairment of the performance of such activities may occur the day following administration of Zolpimist. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.