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.

SONATA (NDA-020859)

(ZALEPLON)

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

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08/18/2019 (SUPPL-16)

Approved Drug Label (PDF)

Boxed Warning

Newly added section:

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

4 Contraindications

Additions and/or revisions underlined:

Sonata is contraindicated in patients:

who have experienced complex sleep behaviors after taking Sonata.

5 Warnings and Precautions

PRECAUTIONS

General

Additions and/or revisions underlined:

Use in Patients with Depression

In primarily depressed patients treated with sedative-hypnotics, worsening of depression, including suicidal thoughts and actions (including completed suicides), have been reported. As with other sedative/hypnotic …

Allergic-Type Reactions FD&C Yellow No. 5

This product contains FD&C Yellow No. 5 (tartrazine) …

Information for Patients

Instruct patients and their families that Sonata 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 Sonata and notify their healthcare provider immediately if they develop any of these symptoms.

WARNINGS

Newly added:

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 Sonata. Patients can be seriously injured or injure others during complex sleep behaviors. Such injuries may result in a fatal outcome. a. 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 Sonata alone at recommended dosages, with or without the concomitant use of alcohol or other central nervous system (CNS) depressants.

CNS-Depressant Effects and Next-Day Impairment

… Coadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression. Dosage adjustments of Sonata and of other concomitant CNS depressants may be necessary when Sonata is administered with such agents because of the potentially additive effects. The use of Sonata 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 Sonata is taken with less than a full night of sleep remaining (7 to 8 hours); if a higher than the recommended dose is taken; if coadministered with other CNS depressants or alcohol; or if coadministered with other drugs that increase the blood levels of zaleplon. Patients should be warned against driving and other activities requiring complete mental alertness if Sonata is taken in these circumstances.

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 (7-8 hours) is recommended.

Additions and/or revisions underlined:

Need to Evaluate for Co-morbid Diagnoses

Because sleep disturbances …

Withdrawal Effects

Following rapid dose decrease or abrupt discontinuation …

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 SONATA?

SONATA may cause serious side effects including complex sleep behaviors that may cause serious injury and death. After taking SONATA, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with SONATA whether or not you drink alcohol or take other medicines that make you sleepy.

Important

Do not take SONATA 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 SONATA.

Stop taking SONATA and call your doctor right away if you find out that you have done any of the above activities after taking SONATA.

02/06/2019 (SUPPL-15)

Approved Drug Label (PDF)

5 Warnings and Precautions

WARNINGS

Abnormal Thinking and Behavioral Changes

(additions underlined)

…

Because Sonata 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)

Information for Patients

(additions underlined)

…

Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients.