Is Lunesta (Eszopiclone) Safe During Pregnancy?

What does the evidence say about lunesta during pregnancy?

1. Eszopiclone itself has no adequate, well-controlled studies in pregnant women, and it has historically carried an FDA pregnancy category C classification, meaning it should be used in pregnancy only if the potential benefit outweighs the potential risk. 1
2. Most of the pregnancy safety data for this drug class actually comes from zolpidem, since data specific to eszopiclone and zaleplon are much more limited. 2
3. Zolpidem, the most-studied drug in this class, hasn't been linked to a higher chance of birth defects across several studies, though some research found a slightly higher chance of early delivery or a smaller baby, an association that didn't fully account for other factors like the insomnia itself. 3
4. Across this drug class as a whole, first-trimester exposure hasn't been clearly tied to a higher rate of birth defects, though evidence on preterm birth and low birth weight is mixed, and cognitive behavioral therapy for insomnia is generally recommended as the first-line approach before medication. 2
5. No data are available specifically on eszopiclone during breastfeeding, but data on the closely related drug zopiclone suggest an exclusively breastfed infant would get roughly 1.2% to 1.4% of the mother's weight-adjusted dose, with reassuring findings in the few case reports available. 4

Is lunesta safe in each trimester?

• First trimester. Eszopiclone hasn't been specifically studied in pregnant women in the first trimester or any other. If insomnia is significant enough that you and your provider are considering medication this early, cognitive behavioral therapy for insomnia is generally recommended as the first approach, with medication reserved for when that's not enough.
• Second trimester. The same evidence gap continues here: there's no dedicated eszopiclone pregnancy data by trimester. Related drugs in this same class as a group haven't been clearly tied to a higher chance of birth defects, though evidence on preterm birth and low birth weight for the class overall is mixed.
• Third trimester. No third-trimester-specific data exists for eszopiclone either. If you and your provider decide medication is the right call, that decision weighs the benefit of managing significant insomnia against the limited data available, rather than against a known, well-quantified risk.