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It is important to be aware of the safety information and potential risks associated with the use of this medication. Below are some key warnings and precautions to consider:

• Abnormal Sleep Behaviors: This medication can lead to activities like sleepwalking, sleep-driving, or sleep-eating while not fully awake. Such behaviors can be dangerous and possibly lead to serious injury or death. These incidents may occur even at the recommended dose and users might not recall them. If you experience any such events, discontinue the medication and consult your healthcare provider immediately. Combining this medication with alcohol or other sleep-inducing medications can increase these risks.

• Daytime Sleepiness and Lowered Alertness: Users may experience daytime drowsiness, dizziness, or confusion, especially when the drug is used with alcohol, benzodiazepines, opioids, or tricyclic antidepressants. Inform your healthcare provider if you are taking these substances, as dosage adjustments might be necessary.

• Severe Allergic Reactions: There is a risk of severe allergic reactions, such as angioedema characterized by swelling of the tongue, lips, throat, or mouth, and symptoms like difficulty breathing, nausea, or vomiting. These reactions can be life-threatening, and emergency medical assistance should be sought immediately if they occur.

• Abnormal Thoughts, Behavior Changes, and Depression: The medication may cause changes in mood or behavior, including aggression, agitation, or hallucinations. It is important to report any such changes to your healthcare provider for evaluation. This is particularly relevant for individuals with a history of depression or suicidal thoughts.

• Slowed Breathing: The drug may cause slowed breathing, particularly in individuals with sleep apnea or who are using opioids or similar medications. Notify your healthcare provider if you experience any changes in breathing patterns.

• Liver Damage in Individuals with Liver Problems: Those with liver conditions may not process the medication efficiently, increasing the risk of side effects. It is advised to avoid this medication if you have severe liver issues, as it could lead to brain damage (encephalopathy). Inform your healthcare provider about any pre-existing liver conditions before starting treatment.

• Withdrawal Symptoms: Long-term use of this medication can lead to tolerance and dependence. Abrupt cessation or dose reduction may cause withdrawal symptoms such as nausea, vomiting, sweating, tremors, panic attacks, and other distressing symptoms. Consult your healthcare provider if you experience withdrawal symptoms.

• Contraindications: Do not use this medication if you have experienced abnormal sleep behaviors like sleepwalking, sleep-driving, or sleep-eating after taking it.

Always discuss with your healthcare provider any concerns or conditions that might affect the use of this medication to ensure its safe use.

Common side effects:

• headache
• sleepiness
• dizziness
• diarrhea

Less common but important to monitor:

• nausea
• dry mouth
• back pain
• flu-like symptoms
• chest pain
• fatigue
• lightheadedness
• depression
• abnormal dreams
• memory loss
• stomach pain
• constipation
• sinus infections
• sore throat
• rash

Serious side effects:

• dangerous sleep behaviors (e.g., sleepwalking or sleep driving)
• slowed brain activity leading to excessive sleepiness or confusion
• trouble breathing with shallow or slow breaths
• severe allergic reactions
• thoughts of suicide
• changes in mood

Interactions with high risk of serious adverse effects and should be avoided:

• Sodium Oxybate
• Calcium Oxybate
• Magnesium Oxybate
• Potassium Oxybate

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Alprazolam
• Carisoprodol
• Codeine
• Cyclobenzaprine
• Diazepam
• Hydrocodone
• Ketoconazole
• Lorazepam
• Bupropion
• Desipramine
• Fluvoxamine
• Rifampin
• Sertraline
• St. John's Wort
• Venlafaxine