reptides / armodafinil

armodafinil

Armodafinil reliably improves wakefulness in approved sleep disorders and reduces vigilance lapses during acute sleep loss. It cannot replace sleep, and the cited evidence does not establish better cognition in rested healthy people.

Small-molecule prescription wakefulness drug

  • Two randomized studies found better wakefulness and simple sustained attention during one acute sleep-loss episode in healthy men.
  • In shift-work disorder, wake latency improved from 2.3 to 5.3 minutes; substantial residual sleepiness remained.
  • The terminal half-life is about 15 hours, which can extend exposure into intended sleep.
  • A 2025 seven-day Chinese PK study reported fever in 6/12 and 7.8-fold sulfone-metabolite accumulation.
Identity and approval Narcolepsy trial Acute sleep loss Night-shift evidence Versus modafinil Other cognition trials Duration and PK Chinese formulation work Risks and interactions

How is armodafinil related to modafinil?

Armodafinil is the isolated R enantiomer of modafinil and a separate US Schedule IV prescription drug.

Its label covers excessive sleepiness associated with adult narcolepsy, obstructive sleep apnea and shift-work disorder. In OSA it treats sleepiness while airway therapy remains necessary; it does not open the airway.

Nuvigil US prescribing information

FDA prescribing information

Apotex. Nuvigil (armodafinil), US prescribing information, 2025 record.

Armodafinil is approved for adult excessive sleepiness associated with narcolepsy, OSA, or shift-work disorder; the label includes serious skin/hypersensitivity, psychiatric, cardiovascular, driving, and contraceptive cautions.

Participants / model
Adults with the specified sleep disorders
Study design
Prescribing information

Approval concerns a prescription formulation and defined indications; it does not establish healthy-person enhancement.

Read the original source
PubChem: armodafinil chemical identity

Government chemical identity database

National Library of Medicine. PubChem CID 9690109.

C15H15NO2S; molecular weight 273.4 g/mol.

Participants / model
Chemical record
Follow-up
Living database
Study design
Curated structure record

Formula and molecular weight establish the recorded structure, not the contents of a retail product or an effective dose.

Read the original source

How much did it help in narcolepsy?

In a 196-person, 12-week trial, armodafinil improved objective wakefulness and clinician-rated global change versus placebo.

Mean morning-to-afternoon wake latency changed by +1.3 and +2.6 minutes in the 150 and 250 mg groups versus −1.9 minutes with placebo. At least minimal global improvement occurred in 69% and 73% versus 33%. This is treatment of pathological sleepiness, not extra cognition above a healthy baseline.

The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy.

Primary human study

Harsh JR et al. Current medical research and opinion. 2006. PMID 16684437. DOI 10.1185/030079906X100050.

In 196 adults, armodafinil improved objective wakefulness and global clinical ratings versus placebo.

Participants / model
196 adults with narcolepsy
Follow-up
12 weeks
Study design
Randomized multicenter double-blind placebo trial

The trial addresses narcolepsy, not general enhancement in rested healthy people.

Read the original source

Does it preserve performance after staying awake?

Yes for wakefulness and simple sustained attention during one acute sleep-loss episode. Two randomized healthy-male studies found longer wake latency and fewer vigilance lapses.

In 107 men, every tested 100 to 300 mg dose improved wake latency and psychomotor-vigilance lapses. In 135 men undergoing 24-hour sleep loss, wake latency was 27.6 minutes with armodafinil versus 15.3 with placebo.

Neither study proves normal judgment, learning, creativity, driving safety or repeated use while chronically sleep deprived. The dose-ranging trial also found lower subsequent sleep efficiency and some blood-pressure or pulse increases.

Pharmacodynamic effects on alertness of single doses of armodafinil in healthy subjects during a nocturnal period of acute sleep loss.

Primary human randomized challenge study

Dinges DF et al. Current Medical Research and Opinion. 2006. PMID 16393442.

All four armodafinil doses increased wake latency and reduced psychomotor-vigilance lapses during one night of sleep loss; effects varied with dose and concentration.

Participants / model
107 healthy men aged 18 to 40 undergoing acute nocturnal sleep loss
Follow-up
One sleep-loss night with nine-day safety follow-up
Study design
Double-blind placebo- and active-controlled dose-ranging trial

This supports acute vigilance under sleep loss, not complex cognition, rested enhancement or safe repeated sleep restriction.

Read the original source
Maintenance of wakefulness with lisdexamfetamine dimesylate, compared with placebo and armodafinil in healthy adult males undergoing acute sleep loss.

Primary human randomized challenge study

Gasior M et al. Journal of Clinical Psychopharmacology. 2014. PMID 25159886.

Armodafinil increased overnight wake latency to 27.6 minutes versus 15.3 with placebo and improved sustained attention during 24-hour sleep loss.

Participants / model
135 healthy men undergoing 24-hour sleep loss across armodafinil, lisdexamfetamine and placebo arms
Follow-up
One acute sleep-loss episode
Study design
Randomized double-blind active- and placebo-controlled trial

Armodafinil was an active control; this does not establish repeated operational safety or sleep replacement.

Read the original source

What improved in shift-work disorder, and what did not?

A 12-week trial improved nighttime wakefulness, attention, reaction time and selected episodic-memory measures, but left marked residual sleep propensity.

The trial enrolled 254 shift workers, treated 245 and analyzed efficacy in 216; 68/245 withdrew. Mean nighttime sleep latency rose from 2.3 to 5.3 minutes versus 2.4 to 2.8 with placebo. Attention continuity and delayed recall improved, while speed of memory did not survive the final analysis.

A mean five-minute wake latency is still severe sleepiness. Diary reports of fewer errors were self-reported, and one suicidal-ideation serious event in a participant with prior depression was considered possibly related.

Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study.

Primary human study

Czeisler CA et al. Mayo Clinic proceedings. 2009. PMID 19880686. DOI 10.1016/S0025-6196(11)60666-6.

Nighttime sleep latency improved from 2.3 to 5.3 minutes with armodafinil versus 2.4 to 2.8 with placebo.

Participants / model
254 enrolled; 245 treated in safety analysis; 216 in efficacy analysis
Follow-up
12 weeks
Study design
Randomized placebo-controlled trial
Funding
Cephalon funded, co-designed and managed the trial and performed the initial analysis; an academic group independently replicated the analysis.

68/245 treated participants withdrew. Analyses required postbaseline data and used the last available observation. Mean final sleep latency remained only 5.3 minutes. One serious suicidal-ideation event in a participant with prior depression was considered possibly treatment-related.

Read the original source
Nuvigil US prescribing information

FDA prescribing information

Apotex. Nuvigil (armodafinil), US prescribing information, 2025 record.

Armodafinil is approved for adult excessive sleepiness associated with narcolepsy, OSA, or shift-work disorder; the label includes serious skin/hypersensitivity, psychiatric, cardiovascular, driving, and contraceptive cautions.

Participants / model
Adults with the specified sleep disorders
Study design
Prescribing information

Approval concerns a prescription formulation and defined indications; it does not establish healthy-person enhancement.

Read the original source

Is armodafinil proven better than modafinil?

No. A 211-person shift-work trial reported response rates of 72.12% with armodafinil and 74.29% with modafinil and did not show superiority.

The trial used subjective sleepiness and was not an equivalence study. Higher late-shift R-enantiomer exposure in a different acute trial cannot be converted into general clinical superiority.

Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial.

Primary human study

Tembe DV et al. Neurology research international. 2011. PMID 21766023. DOI 10.1155/2011/514351.

Responder rates were 72.12% with armodafinil and 74.29% with modafinil; no significant efficacy difference was demonstrated.

Participants / model
211 Indian patients with shift-work sleep disorder
Follow-up
12 weeks
Study design
Randomized double-blind active comparison
Funding
Emcure Pharmaceuticals supplied investigational products and research grants.

The trial was powered to detect a 19-percentage-point response difference, not designed to demonstrate equivalence. It found no significant response difference between armodafinil and modafinil; objective overnight sleep testing was not performed.

Read the original source

Is armodafinil a general cognitive enhancer?

No consistent global effect appears across disease cohorts, and the cited evidence contains no armodafinil-specific rested-healthy enhancement trial.

A 33-person multiple-sclerosis crossover found delayed verbal recall benefit after correction, while executive function, visual memory, processing speed and fatigue were null. A four-week HIV-fatigue trial improved fatigue but not global cognition. A 60-person schizophrenia trial found no apparent MATRICS composite benefit.

Modafinil studies tested the racemate and do not establish the effect of the isolated R enantiomer.

Impact of armodafinil on cognition in multiple sclerosis: a randomized, double-blind crossover pilot study.

Primary human randomized study

Bruce J et al. Cognitive and Behavioral Neurology. 2012. PMID 22960434.

A single 250 mg dose improved delayed verbal recall after correction, while executive function, visual memory, processing speed and fatigue were null.

Participants / model
33 randomized people with multiple sclerosis; 30 analyzed
Follow-up
Single-dose periods
Study design
Double-blind placebo crossover pilot

Small disease-cohort result requiring replication; not healthy-rested enhancement.

Read the original source
Effect of armodafinil on cognition in patients with HIV/AIDS and fatigue.

Primary human randomized study

McElhiney M et al. Journal of Clinical and Experimental Neuropsychology. 2013. PMID 23944194.

Fatigue response favored armodafinil, but global cognitive change did not; mood differences disappeared when fatigue-related items were removed.

Participants / model
70 randomized adults with HIV-related fatigue; 61 completed both cognitive assessments
Follow-up
Four weeks
Study design
Four-week placebo-controlled trial

Repeated-test improvement occurred in both groups; the result does not establish a direct antidepressant or cognition effect.

Read the original source
Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study.

Primary human randomized study

Kane JM et al. Journal of Clinical Psychiatry. 2010. PMID 20816042.

MATRICS cognitive-composite change was similar across placebo and 50, 100 and 200 mg armodafinil groups.

Participants / model
60 stable antipsychotic-treated adults with schizophrenia
Follow-up
Four weeks
Study design
Four-week double-blind placebo-controlled dose-ranging study

An exploratory negative-symptom signal at 200 mg did not establish cognitive enhancement.

Read the original source

What does a 15-hour half-life mean?

A 15-hour terminal half-life means armodafinil leaves the body slowly. Useful focus does not necessarily last 15 hours, and late exposure can disrupt intended sleep.

In pooled healthy-subject studies, peak concentration occurred around two hours fasting, food delayed the peak two to four hours, steady state appeared by day 7, and exposure at steady state was about 1.8 times a single dose.

In 12 healthy Chinese participants taking 200 mg for seven days, parent exposure accumulated 1.5-fold, the sulfone metabolite 7.8-fold, and fever occurred in 6/12. That study measured PK and safety, not benefit.

Nuvigil US prescribing information

FDA prescribing information

Apotex. Nuvigil (armodafinil), US prescribing information, 2025 record.

Armodafinil is approved for adult excessive sleepiness associated with narcolepsy, OSA, or shift-work disorder; the label includes serious skin/hypersensitivity, psychiatric, cardiovascular, driving, and contraceptive cautions.

Participants / model
Adults with the specified sleep disorders
Study design
Prescribing information

Approval concerns a prescription formulation and defined indications; it does not establish healthy-person enhancement.

Read the original source
Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.

Primary human pharmacokinetic analysis

Darwish M et al. Clinical Drug Investigation. 2009. PMID 19133704.

Peak concentration occurred around two hours fasting, mean half-life was about 15 hours, and steady-state exposure was about 1.8 times single-dose exposure.

Participants / model
119 healthy participants across three randomized studies
Follow-up
Single doses and repeated dosing up to 14 days
Study design
Pooled single- and multiple-dose pharmacokinetic studies

Food delayed the peak by two to four hours; elimination half-life does not equal useful-focus duration.

Read the original source
Pharmacokinetics and Safety of Armodafinil in Chinese Healthy Humans After Multiple-Dose Oral Administration.

Primary human pharmacokinetic study

Lang L et al. Clinical Pharmacology in Drug Development. 2025. PMID 40613661.

Armodafinil accumulated 1.5-fold and its sulfone metabolite 7.8-fold after seven days; fever occurred in 6/12 participants.

Participants / model
12 healthy Chinese participants
Follow-up
200 mg daily for seven days
Study design
Single-center self-controlled repeated-dose study

No efficacy outcome was measured; the indexed abstract does not provide a comparator arm or complete event table.

Read the original source

What about the Chinese microneedle patch?

The experimental transdermal patch has only been tested in sleep-deprived mice. It is not an approved human route.

Selected animal cognition measures and exposure changed. Those findings cannot define a human patch dose or replace oral-tablet clinical evidence.

Application of armodafinil-loaded microneedle patches against the negative influence induced by sleep deprivation

Preclinical primary formulation study

Zhu L, Zhang S, Yu X, Zhu S, Ou G, Li Q, Zhang Y, Wang L, Zhuang X, Du L, Jin Y. Application of armodafinil-loaded microneedle patches against the negative influence induced by sleep deprivation. European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V. 2021. DOI 10.1016/j.ejpb.2021.10.009.

An experimental patch changed exposure and improved selected cognitive measures in sleep-deprived mice.

Participants / model
Sleep-deprived mice; China-based formulation research
Study design
Microneedle formulation, pharmacokinetic and animal behavioral experiments

This preclinical mouse study does not authorize a patch or validate human transdermal dosing.

Read the original source

Which risks matter in real use?

Serious rash or multiorgan hypersensitivity, psychiatric reactions, cardiovascular effects, persistent sleepiness and drug interactions are central label risks.

Hormonal contraception can become less effective during treatment and for one month afterward. Headache, nausea, dizziness and insomnia are common. Mania, hallucinations, aggression and suicidal ideation have been reported.

Average improvement never guarantees safe driving or cancels accumulated sleep debt. Late exposure can erode the next sleep opportunity.

Nuvigil US prescribing information

FDA prescribing information

Apotex. Nuvigil (armodafinil), US prescribing information, 2025 record.

Armodafinil is approved for adult excessive sleepiness associated with narcolepsy, OSA, or shift-work disorder; the label includes serious skin/hypersensitivity, psychiatric, cardiovascular, driving, and contraceptive cautions.

Participants / model
Adults with the specified sleep disorders
Study design
Prescribing information

Approval concerns a prescription formulation and defined indications; it does not establish healthy-person enhancement.

Read the original source
Pharmacodynamic effects on alertness of single doses of armodafinil in healthy subjects during a nocturnal period of acute sleep loss.

Primary human randomized challenge study

Dinges DF et al. Current Medical Research and Opinion. 2006. PMID 16393442.

All four armodafinil doses increased wake latency and reduced psychomotor-vigilance lapses during one night of sleep loss; effects varied with dose and concentration.

Participants / model
107 healthy men aged 18 to 40 undergoing acute nocturnal sleep loss
Follow-up
One sleep-loss night with nine-day safety follow-up
Study design
Double-blind placebo- and active-controlled dose-ranging trial

This supports acute vigilance under sleep loss, not complex cognition, rested enhancement or safe repeated sleep restriction.

Read the original source
Pharmacokinetics and Safety of Armodafinil in Chinese Healthy Humans After Multiple-Dose Oral Administration.

Primary human pharmacokinetic study

Lang L et al. Clinical Pharmacology in Drug Development. 2025. PMID 40613661.

Armodafinil accumulated 1.5-fold and its sulfone metabolite 7.8-fold after seven days; fever occurred in 6/12 participants.

Participants / model
12 healthy Chinese participants
Follow-up
200 mg daily for seven days
Study design
Single-center self-controlled repeated-dose study

No efficacy outcome was measured; the indexed abstract does not provide a comparator arm or complete event table.

Read the original source

Studies and sources

Nuvigil US prescribing information

FDA prescribing information

Apotex. Nuvigil (armodafinil), US prescribing information, 2025 record.

Armodafinil is approved for adult excessive sleepiness associated with narcolepsy, OSA, or shift-work disorder; the label includes serious skin/hypersensitivity, psychiatric, cardiovascular, driving, and contraceptive cautions.

Participants / model
Adults with the specified sleep disorders
Study design
Prescribing information

Approval concerns a prescription formulation and defined indications; it does not establish healthy-person enhancement.

Read the original source
The efficacy and safety of armodafinil as treatment for adults with excessive sleepiness associated with narcolepsy.

Primary human study

Harsh JR et al. Current medical research and opinion. 2006. PMID 16684437. DOI 10.1185/030079906X100050.

In 196 adults, armodafinil improved objective wakefulness and global clinical ratings versus placebo.

Participants / model
196 adults with narcolepsy
Follow-up
12 weeks
Study design
Randomized multicenter double-blind placebo trial

The trial addresses narcolepsy, not general enhancement in rested healthy people.

Read the original source
Armodafinil for treatment of excessive sleepiness associated with shift work disorder: a randomized controlled study.

Primary human study

Czeisler CA et al. Mayo Clinic proceedings. 2009. PMID 19880686. DOI 10.1016/S0025-6196(11)60666-6.

Nighttime sleep latency improved from 2.3 to 5.3 minutes with armodafinil versus 2.4 to 2.8 with placebo.

Participants / model
254 enrolled; 245 treated in safety analysis; 216 in efficacy analysis
Follow-up
12 weeks
Study design
Randomized placebo-controlled trial
Funding
Cephalon funded, co-designed and managed the trial and performed the initial analysis; an academic group independently replicated the analysis.

68/245 treated participants withdrew. Analyses required postbaseline data and used the last available observation. Mean final sleep latency remained only 5.3 minutes. One serious suicidal-ideation event in a participant with prior depression was considered possibly treatment-related.

Read the original source
Armodafinil versus Modafinil in Patients of Excessive Sleepiness Associated with Shift Work Sleep Disorder: A Randomized Double Blind Multicentric Clinical Trial.

Primary human study

Tembe DV et al. Neurology research international. 2011. PMID 21766023. DOI 10.1155/2011/514351.

Responder rates were 72.12% with armodafinil and 74.29% with modafinil; no significant efficacy difference was demonstrated.

Participants / model
211 Indian patients with shift-work sleep disorder
Follow-up
12 weeks
Study design
Randomized double-blind active comparison
Funding
Emcure Pharmaceuticals supplied investigational products and research grants.

The trial was powered to detect a 19-percentage-point response difference, not designed to demonstrate equivalence. It found no significant response difference between armodafinil and modafinil; objective overnight sleep testing was not performed.

Read the original source
PubChem: armodafinil chemical identity

Government chemical identity database

National Library of Medicine. PubChem CID 9690109.

C15H15NO2S; molecular weight 273.4 g/mol.

Participants / model
Chemical record
Follow-up
Living database
Study design
Curated structure record

Formula and molecular weight establish the recorded structure, not the contents of a retail product or an effective dose.

Read the original source
Application of armodafinil-loaded microneedle patches against the negative influence induced by sleep deprivation

Preclinical primary formulation study

Zhu L, Zhang S, Yu X, Zhu S, Ou G, Li Q, Zhang Y, Wang L, Zhuang X, Du L, Jin Y. Application of armodafinil-loaded microneedle patches against the negative influence induced by sleep deprivation. European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V. 2021. DOI 10.1016/j.ejpb.2021.10.009.

An experimental patch changed exposure and improved selected cognitive measures in sleep-deprived mice.

Participants / model
Sleep-deprived mice; China-based formulation research
Study design
Microneedle formulation, pharmacokinetic and animal behavioral experiments

This preclinical mouse study does not authorize a patch or validate human transdermal dosing.

Read the original source
Pharmacodynamic effects on alertness of single doses of armodafinil in healthy subjects during a nocturnal period of acute sleep loss.

Primary human randomized challenge study

Dinges DF et al. Current Medical Research and Opinion. 2006. PMID 16393442.

All four armodafinil doses increased wake latency and reduced psychomotor-vigilance lapses during one night of sleep loss; effects varied with dose and concentration.

Participants / model
107 healthy men aged 18 to 40 undergoing acute nocturnal sleep loss
Follow-up
One sleep-loss night with nine-day safety follow-up
Study design
Double-blind placebo- and active-controlled dose-ranging trial

This supports acute vigilance under sleep loss, not complex cognition, rested enhancement or safe repeated sleep restriction.

Read the original source
Maintenance of wakefulness with lisdexamfetamine dimesylate, compared with placebo and armodafinil in healthy adult males undergoing acute sleep loss.

Primary human randomized challenge study

Gasior M et al. Journal of Clinical Psychopharmacology. 2014. PMID 25159886.

Armodafinil increased overnight wake latency to 27.6 minutes versus 15.3 with placebo and improved sustained attention during 24-hour sleep loss.

Participants / model
135 healthy men undergoing 24-hour sleep loss across armodafinil, lisdexamfetamine and placebo arms
Follow-up
One acute sleep-loss episode
Study design
Randomized double-blind active- and placebo-controlled trial

Armodafinil was an active control; this does not establish repeated operational safety or sleep replacement.

Read the original source
Pharmacokinetic profile of armodafinil in healthy subjects: pooled analysis of data from three randomized studies.

Primary human pharmacokinetic analysis

Darwish M et al. Clinical Drug Investigation. 2009. PMID 19133704.

Peak concentration occurred around two hours fasting, mean half-life was about 15 hours, and steady-state exposure was about 1.8 times single-dose exposure.

Participants / model
119 healthy participants across three randomized studies
Follow-up
Single doses and repeated dosing up to 14 days
Study design
Pooled single- and multiple-dose pharmacokinetic studies

Food delayed the peak by two to four hours; elimination half-life does not equal useful-focus duration.

Read the original source
Pharmacokinetics and Safety of Armodafinil in Chinese Healthy Humans After Multiple-Dose Oral Administration.

Primary human pharmacokinetic study

Lang L et al. Clinical Pharmacology in Drug Development. 2025. PMID 40613661.

Armodafinil accumulated 1.5-fold and its sulfone metabolite 7.8-fold after seven days; fever occurred in 6/12 participants.

Participants / model
12 healthy Chinese participants
Follow-up
200 mg daily for seven days
Study design
Single-center self-controlled repeated-dose study

No efficacy outcome was measured; the indexed abstract does not provide a comparator arm or complete event table.

Read the original source
Impact of armodafinil on cognition in multiple sclerosis: a randomized, double-blind crossover pilot study.

Primary human randomized study

Bruce J et al. Cognitive and Behavioral Neurology. 2012. PMID 22960434.

A single 250 mg dose improved delayed verbal recall after correction, while executive function, visual memory, processing speed and fatigue were null.

Participants / model
33 randomized people with multiple sclerosis; 30 analyzed
Follow-up
Single-dose periods
Study design
Double-blind placebo crossover pilot

Small disease-cohort result requiring replication; not healthy-rested enhancement.

Read the original source
Effect of armodafinil on cognition in patients with HIV/AIDS and fatigue.

Primary human randomized study

McElhiney M et al. Journal of Clinical and Experimental Neuropsychology. 2013. PMID 23944194.

Fatigue response favored armodafinil, but global cognitive change did not; mood differences disappeared when fatigue-related items were removed.

Participants / model
70 randomized adults with HIV-related fatigue; 61 completed both cognitive assessments
Follow-up
Four weeks
Study design
Four-week placebo-controlled trial

Repeated-test improvement occurred in both groups; the result does not establish a direct antidepressant or cognition effect.

Read the original source
Armodafinil as adjunctive therapy in adults with cognitive deficits associated with schizophrenia: a 4-week, double-blind, placebo-controlled study.

Primary human randomized study

Kane JM et al. Journal of Clinical Psychiatry. 2010. PMID 20816042.

MATRICS cognitive-composite change was similar across placebo and 50, 100 and 200 mg armodafinil groups.

Participants / model
60 stable antipsychotic-treated adults with schizophrenia
Follow-up
Four weeks
Study design
Four-week double-blind placebo-controlled dose-ranging study

An exploratory negative-symptom signal at 200 mg did not establish cognitive enhancement.

Read the original source

Why is armodafinil in A tier?

A applies to excessive sleepiness in approved adult sleep disorders. Evidence is also strong for acute vigilance under sleep loss, but not for sleep replacement, global cognition, rested enhancement, anxiety treatment, strength or longevity.

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